Tuesday, December 28, 2010

I think this one deserves...

...the "Cheesiest PR effort of the year by a dry eye product company" award.

It's official: Men make women cry the most

Women knew it all along. And now, a study has confirmed it to the entire world -- nothing makes a girl cry as much as a man.


More than three in four women blame their partners for making them cry, not to mention their fathers or sons, reports The Daily Express.

But 63 per cent of men reckon their wives, girlfriends and even mothers can reduce them to tears, said the study by Rohto Dry Eye Relief.

The survey of 2,000 adults also found that when it comes to men, the pressures of work, being treated badly by the boss or horrid workmates can also bring on the tears.

Work woes have left 32 per cent of Brit women and 22 per cent of English men in tears in the past six months. While family, work and friends are responsible for crying, then modern life has the opposite effect in general because it leaves eyes dry and irritable, said Rohto.

A spokesman for Rohto said: "Despite all the tears, Britain actually has a far greater problem from dry eyes rather than wet ones."

A GP, Dr Sarah Brewer, said: "Dry eyes are a common problem for people who use computer screens, work in a dry, centrally heated environment, use the contraceptive Pill or have underlying illnesses and health conditions.

"Dryness causes discomfort with grittiness and stinging."

Abstract: Prostaglandins for glaucoma - relationship to MGD

And the march goes on... more and more studies will be coming, I'm sure, on the long term side effects of glaucoma meds. This one is interesting, as most have focused on the BAK aspect alone.

Topical Antiglaucoma Treatment With Prostaglandin Analogues May Precipitate Meibomian Gland Disease.
Ophthal Plast Reconstr Surg. 2010 Dec 20. [Epub ahead of print]
Cunniffe MG, Medel-Jiménez R, González-Candial M.
Instituto de Microcirugía Ocular, Barcelona, Spain.

The popular use of topical prostaglandin analogues (TPAs) in glaucoma patients has a well-documented association with changes in number, length, thickness, and growth pattern of eyelashes. A link between meibomian gland disease and seborrheic blepharitis resulting from topical administration of prostaglandin analogues has not been made to the authors' knowledge. A retrospective study of 43 patients presenting for incision and curettage of chalazion to the operating theatre over a 2-year period was performed. The patients' histories were reviewed to establish whether they were using TPAs for glaucoma at the time of surgery. Eight patients (19%) were using TPAs at the time of surgery. No patient had a history of eyelid margin disease before the commencement of TPAs. The exact pathogenesis of how meibomian gland disease is linked to TPA use is unclear. We postulate that the topical application of prostaglandin analogues may contribute to the formation of chalazion by acting directly to stimulate meibomian gland secretion. The authors present the findings of a preliminary case series showing a higher-than-expected incidence of patients using TPAs requiring surgical intervention for chalazion.

Abstract: Strip meniscometry

The Efficacy, Sensitivity and Specificity of Strip Meniscometry in Conjunction with Tear Function tests in the Assessment of Tear Meniscus.
Invest Ophthalmol Vis Sci. 2010 Dec 22. [Epub ahead of print]
Ibrahim OM, Dogru M, Ward SK, Matsumoto Y, Hitomi Wakamatsu T, Ishida K, Tsuyama A, Kojima T, Shimazaki J, Tsubota K.
Johnson & Johnson Ocular Surface and Visual Optics Department, Keio University School of Medicine, Tokyo, Japan;

Purpose:
To evaluate the specificity and sensitivity of strip meniscometry testing (SM) in conjunction with tear function tests in the diagnosis of dry eye (DE) disease and to investigate the effect of SM on reflex tearing.

Methods:
One hundred and seven left eyes of 107 patients with definite DE disease according to the Japanese dry eye diagnostic criteria and 68 left eyes of 68 age and sex matched control subjects were studied. Tear meniscus height (TMH) measurements, fluorescein tear film break-up time (FTBUT), fluorescein (F), Rose Bengal (RB) staining and Schirmer's test-1 (ST) were also performed. The assessment of reflex tearing before and after SM application was assessed with a graticule scale at slit-lamp and by Visante optical coherence tomography. The sensitivity and specificity of SM alone and in combination with tear function tests were also sought.

Results:
The SM scores, TMH measurements, FTBUT values and ST values were significantly lower in dry eye patients compared to the controls (p< 0.001). The RB and F staining scores were significantly higher in the dry eye group than in the control group (p < 0.001). SM strips didn't induce significant changes in relation to reflex tearing. SM had an acceptable sensitivity and specificity.

Conclusions:
Strip meniscometry is a swift, noninvasive and promising method for assessing the tear meniscus volume. The combined SM and FTBUT examination appears to be a sensitive approach in assessment of dry eye disease.

Abstract: Lacrisert case study (long term use)

Sorry but I'm not impressed. OK, so this individual who successfully used Lacriserts for years has Sjogrens, but apparently his/her dry eye was mild enough (we are not told her Schirmer or any other clinical data in the abstract) that she could wear soft contacts all these years.

Long-term use of hydroxypropyl cellulose ophthalmic insert to relieve symptoms of dry eye in a contact lens wearer: case-based experience.
Eye Contact Lens. 2011 Jan;37(1):39-44.
Wander AH.
From the Department of Ophthalmology, University of Cincinnati College of Medicine and Academic Health Center, Cincinnati, OH.

OBJECTIVES:
To report a case in which hydroxypropyl cellulose ophthalmic inserts were successfully used for the treatment of dry eye disease in a contact lens (CLs) wearer for more than 25 years.

METHODS:
Review of clinical findings in a female CL wearer with dry eye spanning more than 30 years. The patient was diagnosed with the Sjögren syndrome and demonstrated inadequate lacrimation as assessed by Schirmer testing. Slitlamp examination demonstrated bilateral corneal stippling with fluorescein and signs of superior limbic keratoconjunctivitis.

RESULTS:
Initially, the patient's symptoms improved with infrequent use of artificial tears. As the signs and symptoms of dry eye disease worsened, the patient initiated therapy with once-daily hydroxypropyl cellulose ophthalmic inserts. Punctal plugs and updating to increasingly oxygen-permeable soft CLs, in combination with continued use of the inserts, largely controlled the signs and symptoms of dry eye disease during a 25-year period. Simultaneous use of the hydroxypropyl cellulose ophthalmic inserts and CLs was well tolerated without any significant side effects or changes in visual acuity.

CONCLUSIONS:
Dry eye is a chronic disease often requiring long-term management. In this case, daily use of hydroxypropyl cellulose ophthalmic inserts effectively treated autoimmune dry eye, providing symptomatic relief, and resulted in improved objective measures of disease severity across several decades. Such an experience is consistent with the available evidence-based data for hydroxypropyl cellulose ophthalmic inserts and supports their use in clinical practice for the treatment of moderate-to-severe dry eye disease.

Abstract: Anxiety and depression in patients with dry eye syndrome

Thank you, thank you, thank you to the doctors in China who took the time to conduct this study. US doctors, can't you get on the ball one of these days and do the same? This is a widespread problem. It's a door I've been beating on for ages and I'd be really gratified to see something more than a passive interest taken in it one of these days.

To me, depression is simply a given with dry eye - the vast majority of people I have been in contact with over the years have suffered from severe depression at some stage in their journey and some have chronic problems with it so long as their pain levels remain high.

This study validates everything I've ever seen. The primary correlation they found was between OSDI (symptom scores... how bad I feel) and depression. Yet still, doctors who don't see a terrible Schirmer or TBUT or a cornea sloughing off persist on brushing off these patients as having nothing to fuss about. This is just wrong, wrong, wrong. When we hurt, it affects a lot more than our eyes.

Curr Eye Res. 2011 Jan;36(1):1-7.
Anxiety and depression in patients with dry eye syndrome.
Li M, Gong L, Sun X, Chapin WJ.
Department of Ophthalmology, EYE & ENT Hospital of Fudan University, Shanghai, China.

Purpose:
This study aimed to determine whether patients with dry eye syndrome [DES] have more symptoms of anxiety and depression than controls without DES.

Methods: In this case-control study, the sample consisted of 89 DES subjects (13 diagnosed with Sjögren's syndrome [SS]) and 73 control subjects. Each subject was diagnosed as having DES or was chosen as a control subject by an ophthalmologist. The Zung Self Rating Anxiety Scales (SAS), Zung Self Rating Depression Scales (SDS), and Ocular Surface Disease Index (OSDI) were administered to all subjects. Scores of SAS and SDS, measuring level of anxiety and depression symptoms, were compared between the DES group and the control group. Correlations with other health status measures were conducted.

Results:
The SAS and SDS scores of the DES group were significantly higher than the control group (P < 0.001, P < 0.001). The prevalence of DES subjects with anxiety or depression symptoms was significantly higher than in the control group (P = 0.003, P < 0.001). In the DES group, SAS scores were found to be correlated with OSDI and educational level. SDS scores were found to be correlated with OSDI. Neither SAS nor SDS scores were correlated with age, sex, household income, tear break up time (BUT), Schirmer Test 1 (S1T), corneal fluorescein staining (FL), or visual acuity.

Conclusion:
Anxiety and depression are correlated with DES, demonstrating that DES is an important public health problem that merits increased attention and research.

Abstract: Graves disease and dry eye

Ocular surface and dry eye in graves' disease.
Curr Eye Res. 2011 Jan;36(1):8-13.
Gürdal C, Saraç O, Genç I, Kırımlıoğlu H, Takmaz T, Can I.
Ankara Atatürk Training and Research Hospital, 2nd Ophthalmology Department, Ankara, Turkey.

Purpose:
To evaluate the tear function tests and the ocular surface damage in Graves' disease (GD) patients either with or without thyroid associated orbitopathy (TAO).

Methods:
Forty-two eyes of 21 randomly selected patients with GD, and 30 eyes of 15 healthy subjects were included in this prospective study. The presence of TAO was evaluated clinically. The palpebral fissure height, degree of proptosis, ocular surface disease index (OSDI), Schirmer tear test, tear break-up time (TBUT), and conjunctival impression cytology were assessed. The results were first compared between the patient and the control groups. Results were then compared between the patients with TAO (group I) and without TAO (group II).

Results:
The mean OSDI score in the patient group was 44.79 ± 11.83 and it was 21.17 ± 9.89 in the control group (p  =  0.001). The mean Schirmer tear test score was 14.4 ± 8.32 mm and 24.9 ± 3.57 mm in the patient and control group, respectively (p  =  0.001). The mean TBUT in the patient group was 7.1 sec. In the control group it was significantly increased to 10 sec (p  =  0.003). The mean proptosis and interpalpebral distance did not show any difference between the GD patients and controls (p > 0.05). The patients with GD showed significant ocular surface damage in which 75.71% had grade 2-3 squamous metaplasia in temporal interpalpebral conjunctiva. Twenty-four (57%) eyes composed group I. There were no differences in the mean OSDI score, Schirmer tear test score, TBUT, and the amount of ocular surface damage between group I and group II (p > 0.05).

Conclusions:
Dry eye findings and the ocular surface damage in GD were most likely associated with the ocular surface inflammation. Before the development of the classic findings of TAO, ocular surface inflammation can be the only presenting clinical sign in GD.

Abstract: Tear proteins during Ramadan fasting

Effect of Ramadan fasting on tear proteins.
Acta Medica (Hradec Kralove). 2010;53(3):147-51.
Sariri R, Varasteh A, Sajedi RH.
Department of Biochemistry, University of Guilan, Faculty of Science, Rasht, Iran. sariri@guilan.ac.ir

Muslims abstain from eating, drinking and smoking from dawn to sunset during the holy month of Ramadan. Prolonged fasting is thought to be among risk factors for many diseases, e.g., cardiovascular, gastrointestinal and various infectious diseases. It could also play a part in several eye diseases, including dry eye syndrome, glaucoma, and cataract. Toxic and oxidative effects due to increased concentrations of some biochemicals as a result of reduction in tear volume thought to play an important role in damaging ocular tissue. Human tear is an important biological fluid similar to blood in many aspects. Tear film is composed of three basic layers i.e. lipid, aqueous and mucin. The tear film covering the ocular surface presents a mechanical and antimicrobial barrier, and endures an optical refractive surface. The aim of this study was to analyze and compare tear protein of volunteers during fasting. Using two reliable analytical methods, i.e. electrophoresis and high performance liquid chromatography (HPLC), we compared tear protein content of sixty volunteers (35 males and 25 females, 23-27 years old) during fasting in holly month of Ramadan (FAST: n = 62) and one month before Ramadan (CTRL: n = 60). The results showed that some identified tear proteins decreased during fasting. On the other hand, the activity of some enzymes such as lysozyme, lactoferrin and alpha amylase also decreased in fasting samples. Electrophoresis results showed that tear protein patterns in FAST (P < 0.05) were different from those of CTRL. There were a few more protein peaks in the FAST group (P < 0.005) than in CTRL.

Abstract: Ocular manifestations of HIV/AIDS

(Shudder) This is the kind of study that just makes you thankful for the 'devil you know'.

Ocular manifestations in HIV/AIDS cases in Nepal.
Nepal J Ophthalmol. 2010 Jan-Jun;2(1):45-50.
Lamichhane G, Shah DN, Sharma S, Chaudhary M.
Lumbini Eye Institute, Bhairahawa, Nepal. gyanu813@gmail.com

BACKGROUND: A significant number of patients with HIV/AIDS can have ocular manifestations. Almost every structure in the eyes can be affected in this condition.

OBJECTIVE: To study various ocular manifestations in the cases known to be infected with HIV.

MATERIALS AND METHODS: A cross-sectional descriptive study was carried out including 117 subjects positive for HIV using the purposive sampling method. Their demographic pattern and ocular findings were studied. Findings were recorded in the pro forma developed for the study.

STATISTICS: SPSS ver 14.0 was used for data analysis. The p value of < 0.05 was considered as significant.

RESULTS: A total of 117 HIV infected cases were included in this study. Among them, 76 (64.95%) were male and 41 (35.05%) female. The mean age of the subjects was 30.04 +/- 11.32 years. The duration of HIV detection ranged from 1-5 years. Ocular complaints were present in 26.49% of the subjects. Ocular manifestations were present in 56% of the patients with complaints and in 27.3% of asymptomatic patients. Ocular involvement was seen in 55 (47%) patients. The common anterior segment findings were herpes zoster ophthalmicus (4.27%), anterior uveitis (2.56%), blepharitis (2.56%) and conjunctivitis (1.7%), whereas HIV retinopathy (19.6%), CMV retinitis (5.1%), ocular toxoplasmosis (2.5%) and presumed ocular tuberculosis (0.85%) were common posterior segment findings. Conclusion: Herpes zoster ophthalmicus, anterior uveitis, HIV retinopathy and CMV retinitis are common ocular manifestations associated with HIV infections.

Abstract: N-3 PUFA deficiency and rat dry eye

Eeeesh... I guess this sort of study is interesting to someone somewhere, but not me, at least not yet.

No consequences of dietary n-3 polyunsaturated fatty acid deficiency on the severity of scopolamine-induced dry eye.
Graefes Arch Clin Exp Ophthalmol. 2010 Dec 16. [Epub ahead of print]
Viau S, Pasquis B, Maire MA, Fourgeux C, Grégoire S, Acar N, Bretillon L, Creuzot-Garcher CP, Joffre C.
Eye and Nutrition Research Group, UMR CSGA 1324 INRA - 6265 CNRS - Université de Bourgogne, 21000, Dijon, France.

PURPOSE:
Epidemiological studies suggest that dietary n-3 polyunsaturated fatty acids (PUFAs) may protect against dry eye. This study aimed to evaluate whether a dietary deficiency in n-3 PUFAs may increase the severity of the pathology in a scopolamine-induced model of dry eye in the rat.

METHODS:
Lewis rats of three consecutive generations were bred under a balanced diet or a diet deprived of n-3 PUFAs. Dry eye was experimentally induced by continuous scopolamine delivery in female animals from the third generation of both groups. After 10 days of treatment, the clinical signs of ocular dryness were evaluated in vivo using fluorescein staining. MHC II and the rat mucin rMuc5AC were immunostained on ocular sphere cryosections. The transcript levels of the pro-inflammatory cytokines interleukin (IL)-1β, IL-6, tumor necrosis factor (TNF)-α and interferon (IFN)-γ were quantified in the exorbital lacrimal glands (LG) and in the conjunctiva using reverse transcription followed by polymerase chain reaction. Lipids were extracted from the exorbital LG for fatty acid analysis of the phospholipids using gas chromatography.

RESULTS:
When compared to control animals, the scopolamine treatment induced an increase in the cornea fluorescein staining score (from 0.5 ± 0.0 to 2.5 ± 1.0 arbitrary units (AU) for the balanced diet and from 1.2 ± 0.8 to 2.6 ± 0.5 AU for the n-3 PUFA-deficient diet); a decrease in rMuc5AC immunostaining in the conjunctival epithelium (-34% for the balanced diet and -23% for the n-3 PUFA-deficient diet); an increase in the LG transcript levels of TNF-α for the balanced diet and of TNF-α and IFN-γ for the deficient diet; an increase in the conjunctival transcript levels of IL-1β and IL-6 for the deficient diet; an increase in arachidonic acid (AA) and in the ∆5-desaturase index (ratio of AA to dihomo-gamma-linolenic acid) in the exorbital LG for both diets. When compared to the balanced diet, the n-3 PUFA-deficient diet induced an increase in the LG transcript levels of IL-6 for the control animals and of TNF-α for the control and dry eye animals as well as an increase in the conjunctival transcript levels of IL-6 for the dry eye animals. There was no significant diet difference in fluorescein staining, rMuc5AC, and MHC II immunostaining scores.

CONCLUSIONS:
sOur data suggest that an n-3 PUFA deficiency does not increase the severity of dry eye in a rat model of dry eye.

Abstract: DHA and dry eye

Docosahexaenoic acid, protectins and dry eye.
Curr Opin Clin Nutr Metab Care. 2010 Dec 13. [Epub ahead of print]
Cortina MS, Bazan HE.
aDepartment of Ophthalmology and Visual Sciences, Illinois Eye and Ear Infirmary, University of Illinois at Chicago, Chicago, Illinois, USA bNeuroscience Center of Excellence, USA cDepartment of Ophthalmology, Louisiana State University Health Sciences Center, New Orleans, Louisiana, USA.

PURPOSE OF REVIEW:
To report recent data on the potential role of omega-3 fatty acids, in particular docosahexaenoic acid and its derivatives, in the treatment of dry eye syndrome.

RECENT FINDINGS:
Dietary supplementation with polyunsaturated fatty acids yields positive results in the improvement of dry eye signs and symptoms. Although several studies have shown this, evidence is still lacking as to which fatty acid or what combination constitutes the most effective treatment. Studies show that treatment with alpha-linoleic acid reduces dry eye-induced inflammation. Eicosapentaenoic acid and docosahexaenoic acid derivatives, particularly resolvin E1 (RvE1) and neuroprotectin D1, appear to be responsible for docosahexaenoic acid's anti-inflammatory effect. This is supported in a study in which topical RvE1 resulted in decreased inflammation in a mouse dry eye model. Topical administration of pigment epithelium-derived factor in combination with docosahexaenoic acid accelerates the regeneration of corneal nerves after their damage during corneal surgery, promoting the return of sensitivity and reducing the signs of dry eye. This combined treatment also reduces objective signs of dry eye, such as rose bengal staining.

SUMMARY:
No firm recommendations can be made regarding optimal dietary supplementation of essential fatty acids that benefit dry eye patients. On the basis of animal data and preliminary human studies, docosahexaenoic acid and its derivatives appear to be a safe, effective topical treatment for dry eye patients. This may result from their role in the resolution of inflammation and the regeneration of damaged corneal nerves.

Abstract: No dry eye, mild dry eye, severe dry eye in the office

This was really rather interesting, comparing 3 different groups (nothing, mild dry eye and severe dry eye, according to symptom scores) on various tests. The mild dry eye group seemed normal on some tests but not others.

Tear Dynamics and Corneal Confocal Microscopy of Subjects with Mild Self-Reported Office Dry Eye.
Ophthalmology. 2010 Dec 9. [Epub ahead of print]
Zhang X, Chen Q, Chen W, Cui L, Ma H, Lu F.

PURPOSE: To investigate changes in tear dynamics and corneal microstructure in mild self-reported office dry eye.

DESIGN: Prospective laboratory investigation.

PARTICIPANTS: Twenty healthy office workers, 20 office workers with mild self-reported dry eye, and 20 office workers with moderate to severe dry eye as determined by the Ocular Surface Disease Index (OSDI).

METHODS: Real-time anterior segment optical coherence tomography was used to obtain upper (UTMV), lower (LTMV), tear meniscus volumes. The total tear meniscus volume (TTMV) was the sum of the UTMV and LTMV. This was followed by measurement of noninvasive tear breakup time (NITBUT), fluorescein tear breakup time (FTBUT), fluorescein staining, Schirmer I test, and in vivo confocal microscopy of cornea.

MAIN OUTCOME MEASURES: Upper tear meniscus volume, LTMV, TTMV, NITBUT, fluorescein tear FTBUT, fluorescein staining, Schirmer I test, and in vivo confocal microscopy of cornea.

RESULTS: There were no significant differences in UTMV and LTMV between the control and mild self-reported dry eye groups (P>0.05). These values in the moderate to severe dry eye group were significantly lower than those in the control and mild dry eye groups (P<0.01). Both mild and moderate to severe office dry eye groups had decreased NITBUT (P<0.05 each) and FTBUT (P<0.01 each) compared with controls. On the basis of receiver operating characteristic curves, the cutoff value for abnormal FTBUT was 3.3 seconds, yielding good diagnostic accuracy with a sensitivity of 0.75 and specificity of 0.80. For NITBUT, when the cutoff time was 9.7 seconds, the sensitivity was 0.90 and specificity was 0.50. The moderate to severe office dry eye group had decreased Schirmer I test values and increased subbasal nerve tortuosity compared with the mild office dry eye and control groups (P<0.05 each). Both the mild dry eye and moderate to severe dry eye groups had decreased cell densities in superficial, intermediate, and basal epithelial layers compared with the controls (P<0.05 each).

CONCLUSIONS: Although the quantity of tears in patients with mild self-reported office dry eye was not decreased, ocular surface damage was present.

FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Wednesday, December 22, 2010

Drug news: DIQUAS launched in Japan

After approval earlier this year, DIQUAS (diquafosol tetrasodium - known as Prolacria in the US where it failed three times to achieve FDA approval) was launched in Japan this month.

Inspire Pharmaceuticals Inc unveils DIQUAS for dry eye patients in Japan
December 14 - Tradingmarkets.com

Biopharmaceutical company Inspire Pharmaceuticals Inc (NASDAQ: ISPH | PowerRating) revealed on Monday the receipt of pricing approval of DIQUAS Ophthalmic Solution 3% (diquafosol tetrasodium) as a new treatment option for dry eye patients in Japan.

The product DIQUAS has been launched today in Japan by the company's partner, Santen Pharmaceutical Co Ltd.

Under an agreement, Inspire will receive a related milestone payment of USD1.25m in the fourth quarter of 2010 as well as is entitled to receive payments based upon a tiered royalty rate on net sales of DIQUAS in Japan, with a minimum rate in the high single digits and a maximum rate in the low double digits.

Monday, December 13, 2010

Abstract: Dry eye from systemic drugs

This is just a very brief abstract but I thought it was encouraging that dry eye was at the top of the list of ocular side effects being looked at in systemic drugs.

Ocular Complications of Systemic Medications.
Am J Med Sci. 2010 Dec 6. [Epub ahead of print]
Blomquist PH.
From the Department of Ophthalmology, University of Texas Southwestern Medical Center, Dallas, Texas.

Systemic medications can have adverse effects on the eyes that range from dry eye syndrome, keratitis and cataract to blinding complications of toxic retinopathy and optic neuropathy. This review focuses on major drugs with common ocular side effects and highlights more recently recognized associations with systemic medications. Recommendations for ocular monitoring are given for medications with frequent and/or severe adverse ocular effects.

Abstract: Acupuncture (again)

Acupuncture reduces symptoms of dry eye syndrome: a preliminary observational study.
J Altern Complement Med. 2010 Dec;16(12):1291-4.
Jeon JH, Shin MS, Lee MS, Jeong SY, Kang KW, Kim YI, Choi SM.
1 Acupuncture, Moxibustion, and Meridian Research Center, Korea Institute of Oriental Medicine , Daejeon, South Korea .

Objective:
The aim of this study was to evaluate the effect of acupuncture treatment on dry eye syndrome.

Design: This was a prospective observational study.

Setting: The study was conducted at a clinical evaluation center for acupuncture and moxibustion of the Korean Institute of Oriental Medicine, Republic of Korea.

Subjects: The subjects were patients with dry eye disease (N = 36), defined by Schirmer test scores of <10 mm/5 min and tear film break-up times (BUTs) of <10 seconds.

Treatments: Participants were treated with acupuncture three times per week for 4 weeks. Measure of effectiveness: Schirmer test scores, BUTs, symptom scores, ocular surface disease index (OSDI) scores and dry eye symptom questionnaires were compared before and after treatment to evaluate the efficacy of acupuncture treatment.

Results: After treatment, symptom scores, OSDI scores and the number of dry eye symptoms were all significantly lower (p < 0.0001). Although tear wettings were significantly higher (left: p < 0.0001, right: p = 0.0012), there were no significant differences in BUTs.

Conclusions: This study suggests that acupuncture treatment can effectively relieve the symptoms of dry eye and increase watery secretion.

Abstract: Tobradex vs. Azasite for bleph

Evaluation of clinical efficacy and safety of tobramycin/dexamethasone ophthalmic suspension 0.3%/0.05% compared to azithromycin ophthalmic solution 1% in the treatment of moderate to severe acute blepharitis/blepharoconjunctivitis.
Curr Med Res Opin. 2010 Dec 7. [Epub ahead of print]
Torkildsen GL, Cockrum P, Meier E, Hammonds WM, Silverstein B, Silverstein S.
Andover Eye Associates, Andover, MA, USA.

Objective:
To evaluate the clinical efficacy and safety of tobramycin/dexamethasone (TobraDex ST * ; 'ST') ophthalmic suspension 0.3%/0.05% compared to azithromycin (Azasite † ) ophthalmic solution (1%) in the treatment of moderate to severe blepharitis/blepharoconjunctivitis.

Research design and methods:
The study was a multicenter, randomized, investigator-masked, and active-controlled, 15-day study. Enrolled in the study were 122 adult subjects (at least 18 years of age) diagnosed with moderate to severe blepharitis/blepharoconjunctivitis, defined by a minimum score of at least '1' for one of the lid signs, one of the conjunctival signs, and one of the symptoms in at least one eye and a minimum global score (total signs and symptoms score) of '5' in the same eye. One group of 61 subjects received ST with instructions to dose 1 drop four times daily (QID) for 14 days. The other group of 61 subjects received azithromycin and dosed with 1 drop twice daily (BID) for 2 days followed by once daily (QD) dosing for 12 days. Visits were conducted at Day 1 (baseline), Day 8 and Day 15. The a priori primary outcome parameter of the study was the seven-item global score defined as the total score of lid margin redness, bulbar conjunctival redness, palpebral conjunctival redness, ocular discharge (0-3 scale), and lid swelling, itchy eyelids, and gritty eyes (0-4 scale). The study utilized standardized, validated photograph control scales developed by Ora, Inc. (Andover, MA).

Clinical trial registration:
The study was registered at ClinicalTrials.gov under the registry number NCT01102244.

Results: A statistically significant lower mean global score (p = 0.0002) was observed in subjects treated with ST compared to subjects treated with azithromycin at Day 8. No serious adverse events were reported during the course of the study in either group.

Conclusion: ST provides a fast and effective treatment of acute blepharitis compared to azithromycin. Initial therapy with the combination of tobramycin/dexamethasone provides faster inflammation relief than azithromycin for moderate to severe blepharitis/blepharoconjunctivitis.

Abstract: Lotemax buffering Restasis

We needed another study to tell us that Lotemax helps Restasis not to burn?

Topical Loteprednol Pretreatment Reduces Cyclosporine Stinging in Chronic Dry Eye Disease.
J Ocul Pharmacol Ther. 2010 Dec 6. [Epub ahead of print]
Sheppard JD, Scoper SV, Samudre S.
1 Virginia Eye Consultants and the Department of Ophthalmology, Eastern Virginia Medical School , Norfolk, Virginia.

Purpose:
This retrospective, clinical comparative analysis describes differences in clinical signs and symptoms and medication tolerability between those patients who receive topical corticosteroids prior to initiation of topical cyclosporine 0.5% emulsion (tCSA) therapy for chronic dry eye disease (CDED) and those who received tCSA and were not first induced with corticosteroid drops. tCSA is the only approved medication for CDED. Stinging is the most common side effect of tCSA and reason for tCSA discontinuation. This analysis describes an effective pharmacologic means to reduce tCSA stinging and subsequent discontinuation.

Methods:
Thirty-six consecutive patients were initially treated with loteprednol etabonate (LE) 0.5% (Lotemax; Bausch & Lomb) for a period ranging from 2 to 16 months prior to institution of concomitant tCSA (Restasis™; Allergan). Clinical parameters (fluorescein staining, conjunctival redness, tear meniscus) were compared over a period of 6 months to a second cohort of 36 consecutive patients who were initially prescribed continuous tCSA without concomitant LE pretreatment. Patients in the LE pretreatment group discontinued LE after 3-6 months of concomitant therapy while continuing tCSA therapy.

Results:
Of the 36 LE pretreatment patients, only 2 developed significant stinging (5.5%) and 1 discontinued the use of tCSA because of stinging (2.8%). Of the patients without LE pretreatment, 8 developed stinging (22%) and 3 discontinued tCSA as a result (8.3%). The intergroup P value was significant for severe stinging (<0.02) and for tCSA discontinuation because of severe stinging (<0.04). Patients in the LE pretreatment group had no statistically significant differences in preenrollment disease severity or demographics (P range from 0.19 to 0.59) compared with the group without pretreatment.

Conclusion:
Topical corticosteroid preparation of the ocular surface in CDED with LE induction therapy may reduce discomfort from subsequent long-term maintenance topical medications, particularly tCSA. This analysis describes a readily available induction and maintenance pharmacologic strategy to reduce tCSA stinging and subsequent discontinuation.

Abstract: Impression cytology and dry eye signs/symptoms

How closely does impression cytology correlate with dry eye signs and symptoms? Not very, apparently.

[Clinical- histological correlation in pacients with dry eye.]
Arch Soc Esp Oftalmol. 2010 Jul;85(7):239-245.
[Article in Spanish]
Morales-Fernández L, Pérez-Álvarez J, García-Catalán R, Benítez-Del-Castillo JM, García-Sánchez J.
Unidad de Superficie ocular, Hospital Clínico San Carlos, Madrid, España.

AIM: It is well known that there is a lack of association between symptoms and signs in patients with dry eye disease. The purpose of this study was to assess if there was any agreement between common dry eye diagnostic tests and to compare them with impression cytology.

METHODS: A total of 40 patients were enrolled in this cases-controls study. The group of cases consisted of 20 patients previously diagnosed with dry eye and the controls were 20 volunteers. The examination included: the quality of life test OSDI, break up time test (BUT), fluorescein staining, Schirmer's test and finally the study of goblet and conjunctival epithelial cells with impression cytology. The Student t and U Mann-Whitney tests were used to evaluate the results, and Spearmańs Rho coefficient to assess their correlation.

RESULTS: Statistical differences were observed between cases and controls Group for all tests (P<0.0001). After assessing the good correlation between BUT, fluorescein staining and Schirmer's test, we studied their association with the impression cytology. The number of isolated goblet cells showed a weak association with the majority of tests, however the grade of metaplasia showed a greater association.

CONCLUSION: Impression cytology is a valuable test in the diagnosis of dry eye. Although the number of goblet cells is not a sufficient diagnostic criterion, its joint assessment with the grade of metaplasia and the other dry eye tests is useful.

Abstract: Gold weight implants for non-facial palsy

Wish they told us how these patients actually felt and what clinical dry eye signs they might have had.

Blink Lagophthalmos and Dry Eye Keratopathy in Patients with Non-facial Palsy: Clinical Features and Management with Upper Eyelid Loading.
Ophthalmology. 2010 Nov 18. [Epub ahead of print]
Patel V, Daya SM, Lake D, Malhotra R.
Corneoplastic Unit, Queen Victoria Hospital, East Grinstead, United Kingdom.

PURPOSE: To evaluate the outcome of using upper eyelid gold weight implantation for patients with non-paralytic lagophthalmos on blink (LOB) only. We highlight the features of incomplete blink and reduced blink rate in patients with non-facial palsy as an exacerbating factor in dry eye keratopathy.

DESIGN: Retrospective, noncomparative case series.

PARTICIPANTS: Twelve patients (21 procedures) who underwent upper eyelid gold weight implantation for non-paralytic LOB only.

METHODS: Retrospective case note review of patients who underwent upper eyelid loading for non-paralytic LOB only over a 5-year period at a single institution.

MAIN OUTCOME MEASURES: Improvement in LOB, gentle and forced closure, increased frequency of blinking (FOB), degree of corneal staining, incidence of epithelial defects or corneal ulcer, improvement in vision, and subjective improvement in ocular discomfort.

RESULTS: Twenty-one procedures in 12 patients. Nine patients underwent bilateral surgery. Mean age was 56 (range, 8-80) years. Median postoperative follow-up was 15 months, and mean follow-up was 20.38±16.61 (6-58) months. Eleven of 12 patients had an improvement in LOB and increased FOB, resulting in improvement of keratopathy and reduced ocular discomfort. One patient developed superior corneal thinning and descemetocele, requiring removal of the gold weight; 1 patient required ptosis surgery; and 1 patient developed a gold allergy and underwent platinum chain exchange.

CONCLUSIONS: We highlight the need to consider incomplete blink and reduced FOB as exacerbating factors for corneal-related disorders, including dry eye. Upper eyelid loading with gold weight implantation is a useful and predictive method of improving exposure-related keratopathy due to LOB in the absence of facial palsy.

FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.

Abstract: SPHP700-3 (OTC drop)

Don't get excited yet. It's apparently a povidone OTC drop "showed to be safe and effective in mild to moderate dry eye". The same could probably be said of any OTC lubricant drop... No information available yet to tell us what if anything is different here.

A Multicenter, Double-Blind, Parallel Group, Placebo-Controlled Clinical Study to Examine the Safety and Efficacy of T-Clair SPHP700-3 in the Management of Mild to Moderate Dry Eye in Adults.
Cornea. 2010 Nov 17. [Epub ahead of print]
Villani E, Laganovska G, Viola F, Pirondini C, Baumane K, Radecka L, Ratiglia R.

From the *UO Oculistica, Dipartimento di Neuroscienze e Organi di Senso, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Universitá degli Studi di Milano, Milan, Italy; and †Department of Ophthalmology, Stradins University Hospital, Riga, Latvia.

PURPOSE: To study the safety and efficacy of T-Clair SPHP700-3, a new over-the-counter preservative-free formulation, in the management of mild to moderate dry eye in adults.

METHODS: Sixty adult patients with mild to moderate dry eye were consecutively recruited in 2 eye clinics and randomized into 2 groups: treatment and placebo. Signs and symptoms of dry eye were compared along 28 days of treatment.

RESULTS: No adverse events were reported during the study. Symptoms and signs of dry eye showed significant differences between the 2 groups after 2 and 4 weeks of treatment.

CONCLUSIONS: SPHP700-3 preservative-free formulation showed to be safe and effective in mild to moderate dry eye, improving tear film stability, ocular surface lubrification, and patients' symptomatology.

Abstract: Age-related variations of human tear meniscus...

Age-related Variations of Human Tear Meniscus and Diagnosis of Dry Eye With Fourier-domain Anterior Segment Optical Coherence Tomography.
Cornea. 2010 Nov 23. [Epub ahead of print]
Qiu X, Gong L, Sun X, Jin H.
From the *Department of Ophthalmology, Eye Ear Nose and Throat Hospital of Fudan University, Shanghai, China; and †Department of Biostatistics and Social Medicine, School of Public Health, Fudan University, Shanghai, China.

PURPOSE: To determine the age-related variations in the human tear meniscus using Fourier-domain anterior segment optical coherence tomography (FD-ASOCT) and evaluate its application in dry eye screening and diagnosis.

METHODS: One hundred forty-six patients with dry eye and 160 healthy controls were enrolled in this prospective, randomized, case-control study and grouped according to age: group A (0-19 years), group B (20-39 years), group C (40-59 years), and group D (>60 years). Tear meniscus height, tear meniscus depth, and tear meniscus cross-sectional area (TMA) were measured using FD-ASOCT (RTVue-100); corneal fluorescein staining, tear film breakup time, Schirmer I test, and a dry eye questionnaire were also estimated.

RESULTS: Tear meniscus values were significantly correlated with clinical examination results and dry eye syndrome. Mean tear meniscus height, tear meniscus depth, and TMA values of patients with dry eye were significantly lower than those of the controls (P < 0.05). Tear meniscus values were negatively correlated with age in healthy Chinese subjects. Intraindividual variations in optical coherence tomography results were small in each group. Accuracy of dry eye diagnosis by FD-ASOCT was approximately 70%, and the clinical diagnostic critical point became lower with increasing age. Significant differences were observed in the tear meniscus borderline, TMA, and tear transparency between the 2 groups.

CONCLUSIONS: FD-ASOCT provides blur-free imaging and precise measurement of the tear meniscus, which is consistent with clinical examinations. Therefore, FD-ASOCT is expected to become a valuable technique in dry eye screening and diagnosis.

Drug news: Mimetogan's MIM-D3 starting human clinical

Mimetogen Pharmaceuticals Announces Initiation of Phase II Clinical Trial of Novel NGF Mimetic in Patients with Dry Eye

The Vancouver Sun, November 22, 2010

Mimetogen Pharmaceuticals Inc., a clinical-stage biotechnology company focused on developing novel small molecule compounds that mimic the effects of neurotrophins, today announced that it has initiated the first human clinical trial evaluating MIM-D3, a mimetic of nerve growth factor (NGF), in a Phase II clinical trial in patients with moderate to severe dry eye disease. MIM-D3 is a small cyclic peptidomimetic of NGF, a naturally occurring protein in the eye that is responsible for the maintenance of corneal nerves and epithelium, mucin and tear production.

"This is a key development milestone for Mimetogen, as this trial represents the first use of small molecule mimetics of neurotrophins to treat an ocular disease. Encouraging data in animal models of dry eye suggests that the use of neurotrophin mimetics to treat dry eye and other degenerative ocular indications such as glaucoma is an important new approach to treat ocular diseases for which there are currently very limited treatment options, said Garth Cumberlidge, Ph.D., Chief Executive Officer of Mimetogen. "We are excited to have initiated this study, and anticipate receiving data in mid-2011.”

Drug news: Restasis approved in Canada

I know I reported on this before, but at that time there still weren't any news reports about it. Here's one, albeit with a rather inappropriate title:

NEW TREATMENT TARGETS NATURAL TEARS FOR DRY EYES
TradingMarkets.com

ORONTO, Nov. 25, 2010 (Canada NewsWire via COMTEX) --
RESTASIS(®)(1) is Now Approved by Health Canada for the Treatment of Dry Eye Disease

Allergan is pleased to announce that Health Canada has approved RESTASIS(®) (cyclosporine) ophthalmic emulsion, 0.05% w/v for the treatment of moderate to moderately severe Dry Eye disease ("Dry Eye"). RESTASIS(®) is the first prescription eye drop to target the underlying cause of chronic Dry Eye.

Abstract: Azasite for posterior blepharitis

Efficacy of azithromycin 1% ophthalmic solution for treatment of ocular surface disease from posterior blepharitis.
Clin Exp Optom. 2010 Nov 17. doi: 10.1111/j.1444-0938.2010.00540.x. [Epub ahead of print]
Opitz DL, Tyler KF.
Illinois College of Optometry, Chicago, Illinois, USA Midwest Eye Professionals, Palos Heights, Illinois, USA
E-mail: dopitz@ico.edu.

Background: 
Posterior blepharitis is an eyelid disease primarily of the meibomian glands. Bacteria and chronic inflammation are contributing factors for meibomian gland disease, which leads to ocular surface and tear film alterations and chronic patient symptoms. Azithromycin 1.0% ophthalmic solution is a broad spectrum topical antibiotic with anti-inflammatory properties. The present study evaluates the efficacy of azithromycin 1.0% ophthalmic solution in the treatment of the clinical signs and symptoms, including vision-related function, associated with meibomian gland dysfunction.

Methods: 
In an open label study, 33 patients with meibomian gland dysfunction were treated with azithromycin 1.0% ophthalmic solution twice a day for two days, then every evening for a total of 30 days. Tear break-up time, corneal staining, conjunctival staining, Schirmer scores with anaesthetic, meibomian gland score and patient's symptom scores were evaluated at baseline and after 30 days of treatment. The Ocular Surface Disease Index (OSDI) was administered at baseline, after two weeks of treatment and after 30 days of treatment.

Results: 
Twenty-six of 33 patients completed the study. Tear break-up time and Schirmer score increased by 52.7 per cent (p < 0.0001) and 24 per cent (p < 0.05), respectively. There was a reduction in corneal and conjunctival staining by 83.2 and 67.9 per cent, respectively (p < 0.0001). Lid margin scores were reduced by 33.9 per cent (p < 0.0001). The patient's symptom score improved from 2.73 at baseline to 2.21 after 30 days of treatment (p < 0.01). The mean OSDI at baseline was 34.44. After two weeks and 30 days of treatment, the ODSI was 14.51 and 13.15 respectively (p < 0.0001).

Conclusion: 
These results demonstrate clinically and statistically significant improvement in the signs and symptoms associated with posterior blepharitis. Based on these results, azithromycin 1% ophthalmic solution offers a viable option for the treatment of posterior blepharitis.

Abstract: Avoiding problems in cosmetic eyelid surgery

Eyelid surgeries are a significant cause of dry eye. If you ever consider it, you should have a good corneal specialist involved and make sure the oculaplast really "gets" the issues that can affect the ocular surface.

I really appreciate that in this abstract the author specifically refers to previous LASIK as well as other dry eye risk factors. For too many, eyelid surgery was the the last straw.

Complications in periocular rejuvenation.
Facial Plast Surg Clin North Am. 2010 Aug;18(3):435-56.
Mack WP.
Division of Oculoplastics Surgery, University of South Florida, Tampa, FL, USA. drmack@tampabay.rr.com

Thorough preoperative evaluation with meticulous surgical planning to achieve facial aesthetic balance between the forehead, eyelids, and midface is imperative to avoid or decrease potential functional and/or cosmetic complications in cosmetic periocular surgery. Before performing surgery, the physician should be aware of the patient's history of dry eyes, previous facial trauma, previous injection of Botox Cosmetic, history of previous laser-assisted in situ keratomileusis, and past facial surgery. A full evaluation should be performed on the upper eyelid/brow region to assess for the presence of brow ptosis, brow/eyelid asymmetry, dermatochalasis/pseudodermatochalasis, eyelid ptosis, and deep superior sulcus. On the lower eyelid/cheek examination, special attention should be directed to the diagnosis of underlying negative vector, dry eyes, prominent eyes, lower lid retraction, ectropion, lateral canthal dystopia, lower eyelid laxity, scleral show, and lagophthalmos, with a rejuvenation goal that focuses on obtaining a youthful fullness through repositioning and reinforcing efforts to avoid the negative effects of hollowness. Intraoperative and postoperative medical and surgical management of cosmetic periocular surgery complications focus on decreasing the risk of postoperative ptosis, lagophthalmos, lid retraction, and lid asymmetry, with special attention to limiting the risk of visual loss secondary to orbital hemorrhage.

Abstract: Recalling dry eye symptoms

This is quite an interesting study, all about how well we recall our symptoms. And we remembered pretty darned well, especially if it hurt a lot.

I'd be much more interested to see something tracking this over a longer period. I think most dry eye patients have a pretty good handle on their short term ups and downs - however, longer term it's much harder, which is one of the reasons why I think it's quite useful to complete an OSDI at regular intervals (as well as have objective tests done at the doctor's) to be able to more objectively track our progress and our response to treatments we're on.

Temporal stability in the perception of dry eye ocular discomfort symptoms.
Optom Vis Sci. 2010 Dec;87(12):1023-9.
Cardona G, Marcellán C, Fornieles A, Vilaseca M, Quevedo L.
*PhD †MSc Department of Optometry, University Vision Centre, Universitat Politècnica de Catalunya, Terrassa, Catalonia, Spain (GC, CM, LQ), Centre for Sensors, Instruments and Systems Development (CD6), Universitat Politècnica de Catalunya, Terrassa, Catalonia, Spain (MV), and Psychobiology and Health Sciences Methodology Department, Universitat Autònoma de Barcelona, Bellaterra, Spain (AF).

PURPOSE.:
A prospective longitudinal study was designed to investigate the ability of patients with tear deficiency to correctly recall their past symptoms. The ultimate goal of the study was to contribute to the ongoing research concerning the lack of association between dry eye symptomatology and clinical tests of tear film evaluation.

METHODS.:
A total of 26 subjects with ages ranging from 29 to 61 years participated in the study. All subjects reported symptoms associated with tear deficiency, although none had been diagnosed with dry eye disease. Subjects were instructed to grade their symptoms on two different occasions, at the precise moment they were experiencing them, by means of a home questionnaire, and through a recall questionnaire, which was administered within a maximum interval of 10 days from the first questionnaire. Tear evaluation tests were performed at this second time. Non-parametric statistical analyses were used to investigate the relationship between present and recalled symptoms and between symptoms and signs, as well as between the different dry eye tests. The contributions of age, gender, and recall period were also evaluated.

RESULTS.:
With the exception of irritation (p = 0.029) and scratchiness (p = 0.025), no statistically significant difference was encountered between home and recall questionnaires, although females were found to recall their symptoms slightly better than males (p = 0.048). An increase in the severity of the symptoms was associated with a better recollection (p = 0.007). Symptoms (home or recalled) and clinical signs were not correlated, although the recalled symptom of scratchiness presented moderately strong correlations with several dry eye tests.

CONCLUSIONS.:
Although the lack of correlation between dry eye tests and symptoms mirrored previous research, symptoms recall was found to follow certain interesting patterns, similar to those published in pain research literature.

Abstract: Punctal plugs as a tool for Restasis drug delivery

Ophthalmic delivery of cyclosporine a by punctal plugs.
J Control Release. 2010 Nov 11. [Epub ahead of print]
Gupta C, Chauhan A.

Dry eyes are treated by instillation of eye drops of cyclosporine A emulsion or by punctal plug insertion in canaliculus to block tear drainage. This paper focuses on a novel approach of developing a punctal plug that can also release cyclosporine A to provide a dual mechanism for treating dry eyes. The punctal plug consists of a cylindrical hydroxy ethyl methacrylate core containing drug microparticles surrounded by an impermeable silicone shell that covers about 50% of the core, with the uncovered part directed towards the eyes. The geometry of this design is significantly different from those in patent literature, which are mostly designed to be rods. Plugs release cyclosporine A for a period of about 3months at zero-order at a rate of about 3μg/day. The in vivo release rates are expected to be about half of this value. A mathematical model is presented that provides an accurate estimate of the release without any fitting parameter. Pharmacokinetic models are also developed for drug delivered through Restasis® and punctal plugs, and based on these models the release rate of about 1.5μg/day may be therapeutically effective. The predictions of the ocular pharmacokinetic model are in reasonable agreement with reported measurements in humans.

Abstract: Discoid lupus erythematosus as rare cause of blepharitis

Palpebral involvement as a presenting and sole manifestation of discoid lupus erythematosus.
ScientificWorldJournal. 2010 Nov 4;10:2130-1.
Yaghoobi R, Feily A, Behrooz B, Yaghoobi E, Mokhtarzadeh S.
Department of Dermatology, Jundishapur University of Medical Sciences, Ahvaz, Iran. Yaghoobi_rz@yahoo.com

A 28-year-old woman presented with a 2-year history of idiopathic, chronic blepharitis unresponsive to several courses treatment of corticosteroid eye drops. Physical examination was notable for edematous, erythematous plaques of the lower eyelids with madarosis in the absence of preceding skin scarring. Biopsy specimen was obtained and diagnosis of discoid lupus erythematosus (DLE) was made. DLE is a chronic, cutaneous disease that is clinically characterized by a malar rash, acute erythema, and discoid lesions. Localized DLE occurs when the head and neck only are affected, while widespread DLE occurs when other areas are affected, regardless of whether disease of the head and neck is seen. Patients with widespread involvement often have hematologic and serologic abnormalities, are more likely to develop systemic lupus erythematosus, and are more difficult to treat. A number of skin diseases may be confused with DLE, such as psoriasis, seborrheic dermatitis, acne, rosacea, lupus vulgaris, sarcoidosis, Bowen's disease, polymorphous light eruption, lichen planopilaris, dermatomyositis, granuloma annulare, and granuloma faciale. Palpebral lesions may rarely be the presenting or sole manifestation of the disease and lower eyelid involvement is seen in 6% of patients with chronic, cutaneous lupus erythematosus. DLE should therefore be considered as a differential diagnosis in chronic blepharitis or madarosis that persists despite usual medical management and eyelid hygiene. The patient was treated successfully with hydroxychloroquine. The skin lesions resolved with minimal scarring.

Abstract: Acupuncture for dry eye

Acupuncture for treating dry eye: a randomized placebo-controlled trial.
Acta Ophthalmol. 2010 Dec;88(8):e328-33. doi: 10.1111/j.1755-3768.2010.02027.x. Epub 2010 Nov 10.
Shin MS, Kim JI, Lee MS, Kim KH, Choi JY, Kang KW, Jung SY, Kim AR, Kim TH.
Korea Institute of Oriental Medicine, Daejeon, Korea.

PURPOSE: To evaluate the efficacy and safety of acupuncture for ocular symptoms, tear film stability and tear secretion in dry eye patients.

METHODS: This is a randomized, patient-assessor blinded, sham acupuncture controlled trial. Forty-two participants with defined moderate to severe dry eye underwent acupuncture treatment three times a week for 3 weeks. Seventeen standard points (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8 on the left for men and right for women) with 'de qi' manipulation for the verum acupuncture group and seventeen sham points of shallow penetration without other manipulation for the sham group were applied during the acupuncture treatment. Differences were measured using the ocular surface disease index (OSDI), the visual analogue scale (VAS) of ocular discomfort, the tear film break-up time (BUT) and the Schimer I test with anaesthesia. In addition, adverse events were recorded.

RESULTS: There were no statistically significant differences between results on the OSDI, VAS, BUT or Schimer I tests from baseline between the verum and sham acupuncture groups. However, results from the within-group analysis showed that the OSDI and VAS in both groups and the BUT in the verum acupuncture group were significantly improved after 3 weeks of treatment. No adverse events were reported during this trial.

CONCLUSION: Both types of acupuncture improved signs and symptoms in dry-eye patients after a 4-week treatment. However, verum acupuncture did not result in better outcomes than sham acupuncture.

Drug news: Otsuka seeking approval for Rebamipide in Japan

Otsuka Pharmaceutical Files For Regulatory Approval In Japan For Mucosta® Ophthalmic Suspension For Dry Eye
Medical News Today - November 12, 2010

Otsuka Pharmaceutical Co., Ltd. announced it has applied for regulatory approval in Japan to manufacture and market Mucosta® (rebamipide) ophthalmic suspension for treatment of dry eye. Dry eye is a chronic condition of the corneal and conjunctival epithelia resulting from a range of factors, and involves subjective symptoms including ocular discomfort and visual disturbance.

By its novel mechanism of action to promote the production of mucin in the ocular surface (both the cornea and the conjunctiva), Mucosta ophthalmic suspension stabilizes the tear film and has demonstrated effectiveness in dry eye treatment. In a clinical trial conducted in Japan, it was confirmed that in addition to the improvement in corneal-conjunctival damage in patients with dry eye, Mucosta ophthalmic suspension also showed improvements in subjective symptoms.

Abstract: Herpes zoster ophthalmicus

I have just one word for herpes zoster in the eye... OUCH!!!!!!!!!!

I wish they had mentioned PROSE (Boston scleral) among treatments here as it can be helpful for the pain.

Herpes Zoster Ophthalmicus.
Curr Treat Options Neurol. 2010 Oct 12. [Epub ahead of print]
Sanjay S, Huang P, Lavanya R.
Ophthalmology and Visual Sciences, Khoo Teck Puat Hospital, Alexandra Health, 90 Yishun Central, Singapore, 768828, Singapore, sanjay_s@alexandrahealth.sg.

Abstract
OPINION STATEMENT: The management of herpes zoster (HZ) usually involves a multidisciplinary approach aiming to reduce complications and morbidity. Patients with herpes zoster ophthalmicus (HZO) are referred to ophthalmologists for prevention or treatment of its potential complications. Without prompt detection and treatment, HZO can lead to substantial visual disability. In our practice, we usually evaluate patients with HZO for corneal complications such as epithelial, stromal, and disciform keratitis; anterior uveitis; necrotizing retinitis; and cranial nerve palsies in relation to the eye. These are acute and usually sight-threatening. We recommend oral acyclovir in conjunction with topical 3% acyclovir ointment, lubricants, and steroids for conjunctival, corneal, and uveal inflammation associated with HZO. Persistent vasculitis and neuritis may result in chronic ocular complications, the most important of which are neurotrophic keratitis, mucus plaque keratitis, and lipid degeneration of corneal scars. Postherpetic complications, especially postherpetic neuralgia (PHN), are observed in well over half of patients with HZO. The severe, debilitating, chronic pain of PHN is treated locally with cold compresses and lidocaine cream (5%). These patients also receive systemic treatment with NSAIDs, and our medical colleagues cooperate in managing their depression and excruciating pain. Pain is the predominant symptom in all phases of HZ disease, being reported by up to 90% of patients. Ocular surgery for HZO-related complications is performed only after adequately stabilizing pre-existing ocular inflammation, raised intraocular pressure, dry eye, neurotrophic keratitis, and lagophthalmos. Cranial nerve palsies are common and most often involve the facial nerve, although palsy of the oculomotor, trochlear, and abducens nerves may occur in isolation or (rarely) simultaneously. In our setting, complete ophthalmoplegia is seen more often than isolated palsies, but recovery is usually complete. Vasculitis within the orbital apex (orbital apex syndrome) or brainstem dysfunction is postulated to be the cause of cranial nerve palsies. A vaccine of a lyophilized preparation of the oka strain of live, attenuated varicella-zoster virus is suggested for patients who are at risk of developing HZ and has been shown to boost immunity against HZ virus in older patients.

Abstract: Curcumin

Interesting. Curcumin has been used in dry eye nutritional supplements for quite some time.

Management of chronic anterior uveitis relapses: efficacy of oral phospholipidic curcumin treatment. Long-term follow-up.
Clin Ophthalmol. 2010 Oct 21;4:1201-6.
Allegri P, Mastromarino A, Neri P.
Uveitis Center, Ophthalmological Department of Lavagna Hospital, Genova, Italy.

Curcumin has been successfully applied to treat inflammatory conditions in experimental research and in clinical trials. The purpose of our study is to evaluate the efficacy of an adjunctive-to-traditional treatment with Norflo tablets (curcumin-phosphatidylcholine complex; Meriva) administered twice a day in recurrent anterior uveitis of different etiologies. The study group consisted of 106 patients who completed a 12-month follow-up therapeutic period. We divided the patients into three main groups of different uveitis origin: group 1 (autoimmune uveitis), group 2 (herpetic uveitis), and group 3 (different etiologies of uveitis). The primary end point of our work was the evaluation of relapse frequency in all treated patients, before and after Norflo treatment, followed by the number of relapses in the three etiological groups. Wilcoxon signed-rank test showed a P < 0.001 in all groups. The secondary end points were the evaluation of relapse severity and of the overall quality of life. The results showed that Norflo was well tolerated and could reduce eye discomfort symptoms and signs after a few weeks of treatment in more than 80% of patients. In conclusion, our study is the first to report the potential therapeutic role of curcumin and its efficacy in eye relapsing diseases, such as anterior uveitis, and points out other promising curcumin-related benefits in eye inflammatory and degenerative conditions, such as dry eye, maculopathy, glaucoma, and diabetic retinopathy.

Abstract: Systane vs. Optive

Nobody wins....

Effect of systane and optive on aqueous tear evaporation in patients with dry eye disease.
Eye Contact Lens. 2010 Nov;36(6):358-60.
Wojtowicz JC, Arciniega JC, McCulley JP, Mootha VV.
Department of Ophthalmology, University of Texas Southwestern Medical Center at Dallas, Dallas, TX 75390-9057, USA.

OBJECTIVE: To compare the effect on aqueous tear (AT) evaporation rate of Systane and Optive at 30 min postinstillation in patients with dry eye.

METHODS: In a crossover study of 20 patients with keratoconjunctivitis sicca, the evaporation rate of AT was measured. Evaporometry was used at two relative humidity (RH) ranges of 25% to 35% and 35% to 45%. The measurements were made at baseline (before the instillation of the study agent) and at 30 min after the instillation of 40 μL of either Systane or Optive per randomization assignment per visit with a 1-week interval between visits.

RESULTS: No significant effects on AT evaporation rates at both RHs were found between study agents.

CONCLUSIONS: In our study, neither Systane nor Optive has a significant impact on AT evaporation at 30 min postinstillation in patients with dry eye.

Abstract: Kids, contacts and dry eye

You know, I find the trend to fit younger and younger children with contacts very disturbing. We know from the literature that tear film degrades with age and is at its very best in childhood. Since their tear film is best able to support a lens... this means it's OK to give them lenses and thus extend the years they're going to expose their eyes to this risk?

I myself started wearing contacts in 6th grade, which was unusual back in those days. There was a reason, though, and I certainly didn't seek contacts on my own. I was a very high myope and always had some trouble seeing well with glasses. They tried to put hard lenses on me and it didn't work out. A year or so later I started wearing soft lenses. Over time more and more peers joined me. I kind of think that the younger you start wearing contacts, the more potential for getting really well established in poor eyecare habits. To this day I shudder to think of how I cared for (or didn't) those contacts. During my mid teens I think I did alright, but during late teens and early twenties, I suppose I succumbed to the invincible attitude typical of those ages, not to mention the starving student's attitude to paying for eyecare.

If I could do it all over again, I really think I would have stuck with glasses. But it would have been much easier if small frames had been fashionable when I was young. They weren't, and large frames looked ridiculous in my prescription.

Dry eye in pediatric contact lens wearers.
Eye Contact Lens. 2010 Nov;36(6):352-5.
Greiner KL, Walline JJ.
Davis Duehr Dean Eye Care, Madison, WI, USA.

OBJECTIVE: To determine whether children who wear contact lenses truly have fewer dry eye complaints than adults do.

METHODS: Ninety-four pediatric contact lens wearers, aged 8 to 14 years, were recruited and given the Contact Lens Dry Eye Questionnaire (CLDEQ) short form. The survey is designed to diagnose dry eye syndrome by obtaining information on the frequency of dryness and light sensitivity and their corresponding intensity levels within the first 2 hr of putting in the lenses, in the middle of the day, and at the end of the day. The responses were scored by multiplying the frequency by the average intensity and a constant. A composite score was calculated by subtracting the photophobia score from the dryness score, and the results were compared with those of adult samples from the literature. The questionnaire also asked whether the subject believed he or she had dry eyes while wearing contact lenses. Subjects who believed that they had dry eyes and exhibited a CLDEQ composite score >0.03 were diagnosed with dry eye. Subjects who were unsure if they had dry eyes or said they did not have dry eyes but scored >1.29 were also diagnosed with dry eye.

RESULTS: The average (±SD) age of the sample was 11.7 ± 1.5 years, 56.4% were female, 59.6% were white, and 19.1% were black. The mean (±SD) CLDEQ composite score was 0.25 ± 0.50 (range = -1.20 to 1.45). In the literature, the adult mean (±SD) CLDEQ composite score was 1.02 ± 0.80 (range = -0.74 to 4.50). Of the 94 surveys collected, 4.3% of children were categorized as having dry eye compared with 56.2% of the adults who completed the CLDEQ survey in the adult study.

CONCLUSIONS: Pediatric contact lens wearers have fewer complaints about dry eyes than do adult contact lens wearers, which may be because of improved tear film, differences in reporting of symptoms, or modality of contact lens wear.

Abstract: Causes of inflammation in Demodex-induced bleph

Tear cytokines and chemokines in patients with Demodex blepharitis.
Cytokine. 2011 Jan;53(1):94-9. Epub 2010 Nov 2.
Kim JT, Lee SH, Chun YS, Kim JC.
Department of Ophthalmology, College of Medicine, Chung-Ang University, Yongsan Hospital, 65-207, Hangangro-3Ga, Yongsan-Gu, Seoul 140-757, Republic of Korea.

PURPOSE: The purpose of the study is to evaluate the causes of inflammation in Demodex-induced blepharitis by analyzing cytokine levels in lacrimal fluid.

METHODS: Fifteen Demodex blepharitis patients were selected for assessment of tear cytokine concentrations. Fifteen Demodex-free blepharitis patients and 15 subjects with no ocular symptoms were selected as control groups. Minimally stimulated tear samples (20μl) were collected from each eye and analyzed using a Luminex® 200™ Total System for detection of IL-1β, IL-5, IL-7, IL-12, IL-13, IL-17, granulocyte colony-stimulating factor (G-CSF), and macrophage inflammatory protein-1 beta (MIP-1β).

RESULTS: The concentration of IL-17 in tears was significantly higher in the Demodex blepharitis group than in the Demodex-free blepharitis group. Tear IL-7 and IL-12 levels show serial increases for these three groups (p<0.05). There were no significant differences in the other cytokines levels between both blepharitis groups. We confirmed that elevated cytokines normalized after treatments.

CONCLUSIONS: Infestation of Demodex mites induces change of tear cytokine levels, IL-17 especially, which cause inflammation of the lid margin and ocular surface. These findings might increase our understanding of the mechanism of ocular discomfort and telangiectasias frequently found in Demodex blepharitis patients.

Recruiting for study: Omega 3 study in Houston (post-menopausal women)

Post-menopausal women over 40 needed for dry eye study

Women over the age of 40 who are past menopause can take part in a research study evaluating omega-3 fatty acids or fish oil as a treatment for dry eye.

Recruiting for study: Omega 3 study in Houston

Post-menopausal women over 40 needed for dry eye study

Women over the age of 40 who are past menopause can take part in a research study evaluating omega-3 fatty acids or fish oil as a treatment for dry eye.

Abstract: Surfactant properties of human meibomian lipids

Surfactant properties of human meibomian lipids.
Invest Ophthalmol Vis Sci. 2010 Nov 4. [Epub ahead of print]
Mudgil P, Millar TJ.
School of Natural Sciences, University of Western Sydney, Penrith South DC, Australia.

Purpose:
Human meibomian lipids are the major part of the lipid layer of the tear film. Their surfactant properties enable their spread across the aqueous layer and help maintain a stable tear film. The purpose of this study was to investigate surfactant properties of human meibomian lipids in vitro and to determine effects of different physical conditions such as temperature and increased osmolarity, such as occurs in dry eye, on these properties.

Methods: Human meibomian lipids were spread on an artificial tear solution in a Langmuir trough. The lipid films were compressed and expanded to record the surface pressure-area (Π-A) isocycles. The isocycles were recorded under different physical conditions such as high pressure, increasing concentration and size of divalent cations, increasing osmolarity, and varying temperature.

Results: Π-A isocycles of meibomian lipids showed that they form liquid films which are compressible and multilayered. The isocycles were unaffected by increasing concentrations or size of divalent cations and increasing osmolarity in the subphase. Temperature had a marked effect on the lipids. Increase in temperature caused lipid films to become fluid, an expected feature, but decrease in temperature unexpectedly caused expansion of lipids and an increase in pressure suggesting enhanced surfactant properties.

Conclusions: Human meibomian lipids form highly compressible, non-collapsible, multilayered liquid films. These lipids have surfactants that allow them to spread across an aqueous subphase. Their surfactant properties are unaffected by increasing divalent cations or hyperosmolarity but are sensitive to temperature. Cooling of meibomian lipids enhances their surfactant properties.

Abstract: Diagnosing obstructive MGD vs. aqueous deficient dry eye

I highlighted just one sentence below which I thought was quite interesting. Between aqueous deficient dry eye (naughty lacrimal glands) and obstructive MGD (naughty meibomian glands) not just the symptoms were similar BUT also the lid margins looked the same and the TBUT was similar. Phew. For a moment there I almost felt a little more sympathy for doctors who chronically overlook MGD. But only for a moment. Docs, ya gotta educate yerselves about MGD. Really.

Efficacy of diagnostic criteria for the differential diagnosis between obstructive meibomian gland dysfunction and aqueous deficiency dry eye.
Jpn J Ophthalmol. 2010 Sep;54(5):387-91. Epub 2010 Nov 5.
Arita R, Itoh K, Maeda S, Maeda K, Tomidokoro A, Amano S.
Itoh Clinic, Saitama, Japan.

PURPOSE: To evaluate diagnostic criteria for obstructive meibomian gland dysfunction (MGD) using three parameters (symptom score, lid margin abnormality score, and meibomian gland morphologic change scores) for differentiating obstructive MGD from aqueous deficiency dry eye (ADDE).

METHODS: Twenty-five eyes of 25 patients (mean age, 66.6 years) diagnosed with obstructive MGD and 15 eyes of 15 patients (mean age, 61.3 years) diagnosed with ADDE were analyzed. Ocular symptoms were scored from 0 to 14 according to the number of symptoms. Lid margin abnormality was scored from 0 to 4 according to the number of abnormalities. Meibomian gland changes were scored from 0 to 6 using noncontact meibography (meibo-score). Superficial punctate keratopathy was scored from 0 to 3. Meibum was graded from 0 to 3 according to volume and quality. Tear film break-up time was measured consecutively three times after instillation of fluorescein, and the median value was adopted. Tear film production was evaluated using the Schirmer test.

RESULTS: Ocular symptom and lid margin abnormality scores and tear film break-up time did not differ significantly between the obstructive MGD and ADDE groups. The meibum score and meibo-score were significantly higher in the obstructive MGD group than in the ADDE group. The Schirmer value was significantly lower in the ADDE group than in the obstructive MGD group. When obstructive MGD was diagnosed on the basis of three scores (ocular symptom score, lid margin abnormality score, and meibo-score) all being abnormal, the sensitivity and specificity for differentiating between obstructive MGD and ADDE were 68.0% and 80%, respectively.

CONCLUSIONS: Although the criteria were moderately reliable for differentiating patients with obstructive MGD from those with ADDE when the diagnosis of obstructive MGD was made on the basis of three abnormal scores, they do not provide comprehensive diagnostic tools for differentiating MGD, ADDE, and healthy individuals. We need to add other parameters such as the Schirmer test value and the meibum score to the diagnostic criteria to enhance their reliability for differentiating MGD and ADDE.

Abstract: Sodium hyaluronate and carboxymethylcellulose

This kind of study drives me nuts, because irrespective of the validity of the data, it never tells the real story.

Sounds like a simple proposition: Compare a sodium hyaluronate drop to a carboxymethylcellulose drop. (They're all alike, a dime a dozen, right?) And conclude that they both made people's eyes wetter. Get out. Really? And we all nod and say, I told you so, all artificial tears are more or less the same. But are they?

Back in the days (wave of nostalgia coming...) when I had a little capital and I was able to be more involved with my beloved Dr. Holly's drops, I got a little much-needed education on what goes on in these drops that never shows up on the label... or the study abstract, and probably not even in the whole paper. Take Dwelle for instance. It's povidone and polyvinyl alcohol. Big deal. There's several drops with these ingredients on the market and I think I won't hurt anyone's feelings if I say none of them has ever been thought earth-shattering. Tried one PVA drop, tried 'em, all, right? No, actually, Dr. Holly's drops have a combination of grades of PVA not used in any other drop and this combination (along with the additional polymer) creates uniquely high oncotic pressure values which is what makes his drops effective especially for those with a compromised epithelium.

So circling back to sodium hyaluronate... My industry friends say it's all about the molecular weight. All SH drops are NOT equal, just as all PVA drops are NOT equal.

Bottom line: Do your homework on drops. Don't write them off (and likewise, don't embrace them) just because of a fancy name in the active or in some cases inactive ingredients. Sometimes what's NOT on the label is more telling than what is.

Efficacy of Sodium Hyaluronate and Carboxymethylcellulose in Treating Mild to Moderate Dry Eye Disease.
Cornea. 2010 Oct 28. [Epub ahead of print]
Lee JH, Ahn HS, Kim EK, Kim TI.
From the Department of Ophthalmology, Institute of Vision Research, Yonsei University College of Medicine, Seoul, Korea.

PURPOSE: We compared the efficacy and safety of sodium hyaluronate (SH) and carboxymethylcellulose (CMC) in treating mild to moderate dry eye.

METHODS: Sixty-seven patients with mild to moderate dry eye were enrolled in this prospective, randomized, blinded study. They were treated 6 times a day with preservative-free unit dose formula eyedrops containing 0.1% SH or 0.5% CMC for 8 weeks. Corneal and conjunctival staining with fluorescein, tear film breakup time, subjective symptoms, and adverse reactions were assessed at baseline, 4 weeks, and 8 weeks after treatment initiation.

RESULTS: Thirty-two patients were randomly assigned to the SH group and 33 were randomly assigned to the CMC group. Both the SH and CMC groups showed statistically significant improvements in corneal and conjunctival staining sum scores, tear film breakup time, and dry eye symptom score at 4 and 8 weeks after treatment initiation. However, there were no statistically significant differences in any of the indices between the 2 treatment groups. There were no significant adverse reactions observed during follow-up.

CONCLUSIONS: The efficacies of SH and CMC were equivalent in treating mild to moderate dry eye. SH and CMC preservative-free artificial tear formulations appropriately manage dry eye sign and symptoms and show safety and efficacy when frequently administered in a unit dose formula.

Abstract: Theratears Nutrition

This is kind of, sort of a little bit interesting. Test everyone. Give everyone fish & flaxseed oil daily for three months. Then test 'em again. On the one hand, it sounds like very little changed for anybody in terms of clinical findings. On the other hand, 70% "became asymptomatic". WTH? I'd like to know what they were like to start with. The interesting part is, the authors' conclusions was that it may have helped tear production but didn't do a thing for the lipids or TBUT.

Pilot, Prospective, Randomized, Double-masked, Placebo-controlled Clinical Trial of an Omega-3 Supplement for Dry Eye.
Cornea. 2010 Oct 28. [Epub ahead of print]
Wojtowicz JC, Butovich I, Uchiyama E, Aronowicz J, Agee S, McCulley JP.
From the Department of Ophthalmology, The University of Texas Southwestern Medical Center at Dallas, Dallas, TX.

PURPOSE: To investigate the potential effect of dietary supplementation with omega-3 fatty acid on lipid composition of meibum, aqueous tear evaporation, and tear volume in patients with dry eye.

METHODS: In a pilot, prospective, randomized, double-masked study, patients with dry eye received a daily dose of fish oil, containing 450 mg of eicosapentaenoic acid, 300 mg of docosahexaenoic acid, and 1000 mg of flaxseed oil (TheraTears Nutrition; Advanced Vision Research, Woburn, MA) for 90 days. There were 2 patient visits: baseline and final. At these visits, patients completed the ocular surface disease index to score subjective symptoms, and slit-lamp examinations, breakup time, corneal staining, Schirmer type I, fluorophotometry, evaporometry, and collection of meibomian gland secretion samples for lipid composition analysis were performed.

RESULTS: A total of 36 patients with dry eye completed the study. At the end of the study, 70% of the patients became asymptomatic, whereas for the placebo group, 7% of the symptomatic patients became asymptomatic. Schirmer testing and fluorophotometry suggested that the omega-3 supplement increased tear secretion. The lipid composition of the samples collected from the omega-3 group was found to be very similar to that from the placebo group. No trends between groups were seen for other objective parameters.

CONCLUSIONS: Dietary supplementation with omega-3 fatty acids in dry eye showed no significant effect in meibum lipid composition or aqueous tear evaporation rate. On the other hand, the average tear production and tear volume was increased in the omega-3 group as indicated by both Schirmer testing and fluorophotometry.

Abstract: The economic burden of dry eye disease in the US

This is an interesting summary of estimated costs of managing dry eye. I wonder where they got their recruits? I wish somebody would recruit some DryEyeTalk members.

I suspect this study is looking at people with considerably milder dry eye symptoms than your average DryEyeTalk member or DryEyeBulletin reader. The $783 estimated total annual cost per patient supposedly covers all direct (medical, OTC, etc) and indirect costs. Geez, most dry eye patients I know spend something in that neighborhood annually just in over-the-counter products and eyewear, let alone the cost of doctor visits and prescription drugs and indirect costs like lost workdays. In fact I know an awful lot of people who spend that much on artificial tears each year.

I suppose it is progress that they've included the cost of nutritional supplements, not just drugs, but someday I'd like to see a study that includes things like night goggles and moisture chambers, since protective eyewear is increasingly being recognized as a vital tool for severe dry eye and is usually the highest dollar item on the dry eye shopping list.


The Economic Burden of Dry Eye Disease in the United States: A Decision Tree Analysis.
Cornea. 2010 Oct 28. [Epub ahead of print]
Yu J, Asche CV, Fairchild CJ.
From the *University of Utah, College of Pharmacy, Pharmacotherapy Outcomes Research Center, University of Utah, Salt Lake City, UT; and †Alcon Research, Ltd, Fort Worth, TX.

PURPOSE:
The aim of this study was to estimate both the direct and indirect annual cost of managing dry eye disease (DED) in the United States from a societal and a payer's perspective.

METHODS:
A decision analytic model was developed to estimate the annual cost for managing a cohort of patients with dry eye with differing severity of symptoms and treatment. The direct costs included ocular lubricants, cyclosporine, punctal plugs, physician visits, and nutritional supplements. The indirect costs were measured as the productivity loss because of absenteeism and presenteeism. The model was populated with data that were obtained from surveys that were completed by dry eye sufferers who were recruited from online databases. Sensitivity analyses were employed to evaluate the impact of changes in parameters on the estimation of costs. All costs were converted to 2008 US dollars.

RESULTS:
Survey data were collected from 2171 respondents with DED. Our analysis indicated that the average annual cost of managing a patient with dry eye at $783 (variation, $757-$809) from the payers' perspective. When adjusted to the prevalence of DED nationwide, the overall burden of DED for the US healthcare system would be $3.84 billion. From a societal perspective, the average cost of managing DED was estimated to be $11,302 per patient and $55.4 billion to the US society overall.

CONCLUSIONS: DED poses a substantial economic burden on the payer and on the society. These findings may provide valuable information for health plans or employers regarding budget estimation.

Wednesday, November 3, 2010

Restasis approved in Canada

No fanfare or press release but I just ran across a mention of it in Allergan's 3Q results.

Abstract: MMF

Mol Vis. 2010 Oct 1;16:1913-9.
Effects of mycophenolate mofetil on proliferation and mucin-5AC expression in human conjunctival goblet cells in vitro.
He H, Ding H, Liao A, Liu Q, Yang J, Zhong X.

PURPOSE: To investigate the effects of mycophenolate mofetil (MMF) on proliferation and mucin-5AC (MUC5AC) mRNA expression of normal human conjunctival goblet cells (CGCs) in vitro and to understand mechanisms of MMF in treatment of dry eye syndrome at molecular level.

METHODS: Purified human CGCs were treated with a series of graded concentrations of MMF after being confirmed by immunocytochemistry and flow cytometry. Proliferation and MUC5AC mRNA expression of CGCs were measured by Cell Count Kit-8 (CCK-8) and quantitative nested real-time reverse transcription polymerase chain reaction (QNRT-PCR at 24 h after treatment. The cell proliferation and MUC5AC mRNA expressiion were compared among different doses of MMF.

RESULTS: MMF induced a dose-dependent upregulation of MUC5AC mRNA expression (F=238.851, p<0.01) but a biphase effect on proliferation of the CGCs over 24 h of co-incubation. This biphase effect manifested as a dose-dependent increase in cell numbers with MMF from 0.25 to 2.5 ng/ml, an unchanged population of the cells from 2.5 to 10 ng/ml and a reduced population of the cells from 25 to 100 ng/ml.

CONCLUSIONS: MMF exerts biphase effects on cell regeneration and upregulates MUC5AC mRNA expression in CGCs in vitro. It appears that the use of MMF at low concentrations is attractive in dry eye (DE) treatment.

Abstract: MGD and proteins

Br J Ophthalmol. 2010 Oct 28. [Epub ahead of print]
Association of tear proteins with Meibomian gland disease and dry eye symptoms.
Tong L, Zhou L, Beuerman RW, Zhao SZ, Li XR.
Singapore, Singapore.

Aim
Tear proteins have an important role in the maintenance of the ocular surface and modulation of biological processes, including inflammation, in dry eye. Meibomian gland disease (MGD) is a condition that can increase inflammation in the ocular surface, but tear protein changes due to MGD have not been documented. This study evaluated the possible association of tear proteins with severity of MGD in dry eye.

Methods
Twenty-four patients with dry eye were evaluated. The panel of proteins found previously to be of interest and evaluated in this study were α-enolase, α-1-acid glycoprotein 1, S100A8 (calgranulin A), S100A9 (calgranulin B), S100A4 and S100A11 (calgizzarin), prolactin-inducible protein (PIP), lipocalin-1, lactoferrin and lysozyme. Tear protein ratios for each of 24 patients were calculated relative to pooled control from 18 healthy people, using isobaric tagging for relative and absolute quantification (iTRAQ)-based proteomics combined with two-dimensional-nanoliquid chromatography (LC)-nano-electrospray ionisation (ESI)-mass spectrometry (MS)/MS. The severity of MGD was clinically classified into grades 0-3 based on biomicroscopic signs.

Results
The levels of S100A8 and S100A9 were correlated to MGD severity. The level of S100A8 protein was significantly correlated to grittiness, whereas S100A8 and S100A9 were correlated to symptoms of redness and transient blurring. Lipocalin-1 was associated with heaviness of the eyelids and tearing.

Conclusions
Distinct tear proteins are associated with MGD in dry eye patients, and some proteins were associated with distinct dry eye symptoms. These findings suggest that MGD may independently contribute to the symptomatology of dry eye patients.

Thursday, October 28, 2010

Minor drug updates - RGN259 and RX-10045

1) RGN259 is enrolling for a Phase II trial this quarter and the trial will take place through 2011, according to a recent news report.

2) Rexolvyx has a new partner, Celtic Therapeutics, who have an option to acquire and license RX-10045, according to a press release.

Abstract: Interferometry in evaluating tear film thickness

Am J Ophthalmol. 2010 Oct 21. [Epub ahead of print]
Interferometry in the Evaluation of Precorneal Tear Film Thickness in Dry Eye.
Hosaka E, Kawamorita T, Ogasawara Y, Nakayama N, Uozato H, Shimizu K, Dogru M, Tsubota K, Goto E.
Department of Ophthalmology, School of Dental Medicine, Tsurumi University, Yokohama, Japan.

PURPOSE: To compare tear film thickness between normal subjects and aqueous tear deficiency dry eye patients by tear interferometry.

DESIGN: Prospective case-control study.

METHODS: Central precorneal tear film thickness was measured noninvasively using an interference thin-film thickness measurement device (Quore MSPA1100; Mamiya-OP). Tear film thickness of 14 eyes from 14 normal subjects and of 28 eyes from 28 aqueous tear deficiency dry eye patients were compared along with noninvasively measured tear meniscus height, DR-1 (Kowa) dry eye severity grading, fluorescein and rose bengal staining scores, tear film break-up time, and Schirmer test results. Among dry eye patients, 13 eyes underwent punctal occlusion, and tear film thickness was compared before and after the surgery.

RESULTS: Tear film was significantly thinner in dry eye patients (2.0 ± 1.5 μm) than normal subjects (6.0 ± 2.4 μm; P < .0001). Tear film thickness showed good correlation with other dry eye examinations. After punctal occlusion, tear film thickness increased significantly from 1.7 ± 1.5 μm to 4.9 ± 2.8 μm (P = .001) with the improvement of tear meniscus height, fluorescein and rose bengal staining scores, tear film break-up time, and Schirmer test values.

CONCLUSIONS: Interferometric tear film thickness measurement revealed impaired precorneal tear film formation in aqueous tear deficiency dry eyes and was useful for showing the reconstruction of tear film after punctal occlusion surgery. Interferometry of precorneal tear film may be helpful for the evaluation of aqueous tear deficiency in conjunction with other dry eye examinations.

Abstract: from Spain

I'm just posting this one so Spanish readers (or others in the neighborhood) can take note of the authors in case they are looking for names of doctors or researchers that might take an interest in dry eye.

Ocul Surf. 2010 Oct;8(4):185-92.
The tear film and the optical quality of the eye.
Montés-Micó R, Cerviño A, Ferrer-Blasco T, García-Lázaro S, Madrid-Costa D.
From the Optometry Research Group, Department of Optics, University of Valencia. Spain.

ABSTRACT The stability of the tear film plays an important role in the optical quality of the eye. Various methods have been developed to quantify the contribution of the tear film to optical quality, including the double-pass optical method, Hartmann-Shack wavefront sensing, videokeratoscopy, retroillumination analysis, and interferometry. In addition to assessing the effect of tear film irregularities, these methods can aid in the diagnosis of dry-eye related conditions and the monitoring of therapy. This review describes the methodologies used to assess the relationship between the tear film and optical quality of the eye and summarizes the most important findings obtained with these methods with regard to the healthy human eye, the dry eye, and the effect of artificial tear instillation.

Abstract: SmartPlugs, DumbPlugs and DarnedPlugs

Almost as often as I see a new study on this brand of plugs, I hear of YET ANOTHER patient who is probably facing reconstructive eyelid surgery after having a so-called SmartPlug inexplicably go AWOL in her eyelid.

Stay away from this product - that's all I can say.

A high success rate means nothing when the consequences of being one of the minority failures is so terribly serious.

Some form of simple failure is acceptable for most medical treatments. Catastrophic failure is ABSOLUTELY UNACCEPTABLE for any dry eye treatment.

Nan Fang Yi Ke Da Xue Xue Bao. 2010 Oct 20;30(10):2370-2372.
[Application of Smart Plug lacrimal plug in the treatmengt of dry eye.]
[Article in Chinese]
Guo L, Wu XY, Yuan F, Li B.
Department of Ophthalmology, Qilu Hospital of Shandong University, Jinan 250012, China.


OBJECTIVE: To evaluate the clinical efficacy of Smart Plug lacrimal plug in the treatment of dry eye.

METHODS: Twenty-nine patients with dry eyes (58 eyes) were treated with Smart Plug lacrimal plug. All the patients were follow up for 6-10 months (average 7.8 months). Schirmer I test (SIT), tear break-up time (TBUT) and corneal fluorescein staining were used for evaluation of the clinical efficacy.

RESULTS: The SIT was 3.35∓2.60 mm and 6.35∓4.15 mm, TBUT was 3.14∓1.22 s and 5.46∓1.26 s, and corneal fluorescein staining was 2.15∓0.09 and 0.05∓0.01 before and after the treatment, respectively (P<0.05). The subjective symptoms were improved in most of the patients.

CONCLUSION: Smart Plug lacrimal plug is effective in the treatment of dry eye due to aqueous tear deficiency, and can be one of the choice of dry eye treatment

Wednesday, October 27, 2010

New eyewear: Ziena Oasis



Isn't this a stunning frame?

Would you believe it is also the best non-goggle Rx-able moisture chamber you can buy?

An aesthetically pleasing moisture chamber has always been a contradiction in terms. Most of us have compromised in some way or another with goggles that rate either somewhat or very high on the dorkiness scale. For prescription glasses wearers, the options are narrower (and usually uglier).

Those who can afford to slide up the scale from goggles have had to get either custom moisture chambers built for their glasses, or Micro-Environment Glasses, both of which are very good, but neither of which you would ever consider if you didn't have dry eye.

So the Ziena has arrived to fill an important niche. And you would hardly believe from the picture that it does fill it - but it does.

The frame has a silicone eyecup which attaches with several tiny little magnets. No foam. The silicone is very, very delicate and as it approaches the face curls under slightly. It forms a nice (not airtight) seal most of the way around. It's extremely comfortable. For those of you familiar with MEGs, it's kind of the reverse design in that there is a gap at the top rather than the bottom. Seemed counterintuitive to me and I really wondered how it would perform. But it was great. And once I had these things on my face I didn't want to take them off, outdoors or indoors.

The Ziena is easily the best pair of glasses I have ever had for driving. In a weeklong test, they did not fog - period. Amongst all the 7Eye and Wiley glasses I have ever used (and they are many) all of them have fogged at least occasionally when driving.

The lenses are larger than most 7Eye or Wiley glasses I've had, so my vision was better. And while the silicone eyecup is semi-opaque, it's clear/whitish and light comes through so you don't get any of the tunnel-vision effect most moisture chambers produce. These glasses are real design coup.

So, to boil it down to essentials:

PROS:

1. Beautiful.

2. Effective for dry eye protection.

3. Good vision.

CONS:

1. Price and ongoing expense. With no prescription, you're looking at a minimum of $290, and you're probably going to have to replace that silicone shield ($35) every month or two. It's new, so I really won't know for awhile how long they'll last. I'm not even really sure how to clean it.

2. Hinge placement (see note below)

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For those of you whose dry eyewear budgets are in the double rather than triple digits, don't worry, there's an excellent new product due out soon - probably before the end of the year - that I tested awhile back and really liked! So stay tuned - it'll be in the blog and newsletter when it comes.

FRAMES / LENSES

There are three framestyles: Glossy black, light tortoise, and brown fade. The one pictured above is light tortoise.

Lens options are much as for other 7Eye products:
- Sharpview if you want the basic darker lens for outdoor use
- Photochromic 24:7 lenses for indoor/outdoor (best if you want to use this at the office)
- ColorAmp Polarized
- ColorAmp grey or copper

If you need RX, you can either get a local dealer to produce it for you, get it direct from 7Eye, or purchase the frame on my site and take it to a local optician to get whatever lenses you want in it (including clear lenses).

HOW/WHERE TO BUY:

They are not yet available on the 7Eye website. So:

Local: Call 7Eye or go on their website to get local dealer phone numbers. Not too many dealers have them yet though.

Dry Eye Shop: Click here to buy or just to look at the different frame/lens combinations. I have several of these in stock including frame-only for those who need Rx (I don't sell Rx - you would need to take it to your optician). Anything not showing in stock has to be special-ordered so please allow an extra 5 days for delivery.

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NOTE re: Hinge placement:
This will probably not affect anyone except people like me whose skin is freakishly sensitive to metals (I can't wear necklaces or watches even for one day). The hinge on the Ziena is much further up on the earpiece than 7EYE's other products in order to accommodate the eyecup, so a teensy bit of the metal comes pretty close to my cheek. It's only a little, but after about a week of frequent wear my cheeks broke out. Again, I think very few people would be affected by this. I am so bummed about it because if it weren't for that, I would be wearing this full-time - yes, even at the computer at my home office!