Monday, December 22, 2008

Math quiz

For all you numbers people out there...

The drive plus turnaround is, at a guess, say 175 feet long and ~8 feet wide. The snow is about 15 inches deep. When I'm done clearing it (I'm 95% there),

1) How many cubic feet of snow will I have shoveled?

2) If about 1/3 of the time I had to throw the snow on a pile nearly 5 feet high at the side of the drive, percentage-wise how many more calories did I consume?

3) How much chocolate do I get to eat tonight to make up for all this work?

Friday, December 19, 2008


Welcome to Kitsap County, in the famed temperate climate of the Pacific Northwest.

It's 8pm, 18 degrees Farenheit and dropping.

The latest weather forecast from Komo suggests our snowfall tomorrow night into Sunday is probably going to be measureable in feet. And there is something in how they're phrasing it all that just sounds ominously different than those notorious Seattle attempts at forecasting snow that never materializes.


Something tells me The Dry Eye Shop may not be open for business Monday. I will do my best to get the latest orders packed up and out tomorrow morning for those who may need them before Christmas.

Drug co. news: Inspire lawsuit dismissed

Remember when the FDA said no to Diquafosol for the third time and shareholders got unhappy...?

Inspire have now been vindicated with a Federal court dismissal of the class-action suit.

Federal court dismisses class-action suit against Inspire Pharmaceuticals

Management at Inspire Pharmaceuticals could have one less issue on its plate now that a federal court of appeals has moved to dismiss a class-action suit against the company.

The main claim in the class-action suit against Inspire Pharmaceuticals (Nasdaq: ISPH) is that executives at the Durham company committed securities fraud by overstating the prospects for an experimental dry-eye drug known as diquafosol tetrasodium. That drug failed a late-stage human trial, causing Inspire’s stock to drop more than 40 percent.

But on Dec. 12, the U.S. Court of Appeals for the Fourth Circuit, based in Richmond, Va., ruled that the suit should be dismissed. The plaintiffs didn’t offer enough evidence that Inspire’s executives willfully misled investors about studies of diquafosol tetrasodium, the court says. Rather, the court says, it seems clear that Inspire withheld the information for competitive purposes – a legitimate business purpose.

Thursday, December 18, 2008

winter wonderland and heating woes

I'll try and get a pic uploaded later today. It is SO beautiful here. We're having some very un-Puget-Sound-like winter weather in Poulsbo.

We had about 3" of snow on Saturday, and then it got quite cold... now it's snowing again and we've got a fresh inch or two. We missed the heavy snowfalls of 1-2' that blanketed some areas in Washington, but so much the better, especially given the state of the treads on my tires.

I think I've mentioned that this old farmhouse we've moved to has a wood-burning furnace. It's a bit of work, but I really welcome the exercise dealing with the firewood, and it really pumps out heat. There are ceiling vents downstairs and floor vents upstairs.

However, not too long after we moved in, the fan on the furnace came to a screeching halt. The local heating company (very nice people) took it away and managed to coax it back into some semblance of working order the very day before the temps dipped into the teens.

Only... where the fan was truly blowing before, it now seems to be just kind of reluctantly exhaling. When I found the bedroom not rising about 50 degrees, I called the heating company, who, of course, had about 150 other calls to handle from panicky locals and the last thing they were interested in was an ancient system for which they knew they could not find parts.

So I kept playing around with it, and finally found that if I really stuffed the furnace full and fed it frequently, I could get almost the entire upstairs to a reasonable temperature.

Now this is no small wood-burning stove - it holds quite a bit of wood. So I also let the property manager know that my budget was not anticipating burning a cord of wood a week through the winter and would she pretty please be so kind as to... do something. Word has it the heating company is going to rebuild the motor for me. Sometime. Meantime, it's now a balmy 26 degrees outside and most of the house except my office! is warming nicely. I never before had the opportunity to learn so much about the difference between teens and twenty-something.

Tuesday, December 16, 2008

Newsblurb: Allergan infomercial

Many Women Unaware Of Differences In Common Over-The-Counter Eye Drops

Gee, personally, I woulda said many women are aware of similarities in common over-the-counter eye drops (e.g. they don't work?).

Selecting eye drops can be an overwhelming experience with many different types and brands of over-the-counter eye drops on the market.

Got that part right.

The Red Hot Mamas® and Allergan, Inc., a global leader in eye care, recently conducted a nationwide survey of 371 women ages 45 to 65 who regularly experience at least one symptom of dry eye, and found that two-thirds of women experiencing dry eye symptoms were not aware of any difference between two common types of over-the-counter eye drops that are designed with different purposes-vasoconstrictors and artificial tears.

Got that part right too.

And your competitors over at Pfizer are probably 98% to blame for this by marketing BOTH artificial tears AND vasoconstrictors under the same label (the big V). I have ALWAYS felt that that was an unconscionable move... selling more by creating massive confusion. I haven't looked at the Visine line in awhile but when I last updated the site, there were 9 Visine products, 6 of which contained benzalkonium chloride and therefore are unsuitable for frequent use.

While approximately 20 million people in the United States have experienced dry eye symptoms, a medical condition called chronic dry eye often affects women because of hormonal changes due to aging and menopause. Other causes of dry eye include inflammation, certain medications and various systemic conditions.

You forgot to mention LASIK. If I'm not mistaken, considerably more people in this country have undergone LASIK than suffer from Sjogrens Syndrome, yet somehow, this is always left off the lists in any context in which it might, er, offend someone.

"We encourage women to focus on feeling good about menopause by taking personal control and gathering information during this natural transition," said Karen Giblin, president of Red Hot Mamas, the nation's largest menopause management education organization. "To that end, we are concentrating our efforts on raising awareness of dry eye, an often overlooked consequence of menopause."

I'm thrilled to hear it, and I sure hope your OTHER efforts are not as demeaning as that (shudder) Dry Eye Book Club thing.

"Artificial tears can provide temporary relief of dry eye symptoms, but they do not treat the underlying causes of chronic dry eye. Anyone experiencing the symptoms of dry eye or using artificial tears several times a day or on a regular basis should visit an eye doctor immediately, instead of continuing to try different over-the-counter artificial tears on their own," said Frank A. Bucci Jr., MD, founder and medical director of Bucci Cataract and Laser Vision Institute in Wilkes-Barre, PA. "An eye doctor can diagnose chronic dry eye and may recommend adding a prescription therapy."

Golly gee, that wouldn't be a gentle reference to Restasis, now, would it? (wink)

Monday, December 15, 2008

You mean....?

I got to the end of my list of updates. 25 posts, and a lot more reading of non newsworthy stuff. Un-friggin-believable - I get to finally cross this off my list. I think that is probably the most I've ever done in a single day. What a relief to finally be caught up.


Now, I turn to all the other things where I have equally long lists. Never mind, one at a time, they'll get done. If I ignored your email, forgive me, and call 877-693-7939 (I really do usually call back the same day whenever possible).

Abstract: Ooooh, real science

Judging from the title, anyway.

Modulation of integrin alpha4beta1 (VLA-4) in dry eye disease.
Arch Ophthalmol. 2008 Dec;126(12):1695-9
Ecoiffier T, El Annan J, Rashid S, Schaumberg D, Dana R

OBJECTIVE: To study the effect of topical application of very late antigen 4 (VLA-4) small-molecule antagonist (anti-VLA-4 sm) in a mouse model of dry eye disease.

METHODS: Anti-VLA-4 sm (or control vehicle) was applied topically to mice placed in a controlled-environment chamber. Corneal fluorescein staining and conjunctival T-cell enumeration were performed in the different treatment groups. Real-time polymerase chain reaction was used to quantify expression of inflammatory cytokines in the cornea and conjunctiva.

RESULTS: Dry eye syndrome induced increased corneal fluorescein staining, corneal and conjunctival tumor necrosis factor alpha messenger RNA expression, and T-cell infiltration into the conjunctiva. Very late antigen 4 blockade significantly decreased corneal fluorescein staining compared with the untreated dry eye disease and control vehicle-treated groups (P < .001 and P = .02, respectively). In addition, VLA-4 blockade was associated with a significant decrease in conjunctival T-cell numbers (P < .001 vs control vehicle-treated group) and tumor necrosis factor-alpha transcript levels in the cornea (P = .04 vs control vehicle-treated group) and conjunctiva (P = .048 vs control vehicle-treated group).

CONCLUSION: Application of topical anti-VLA-4 sm led to a significant decrease in dry eye signs and suppression of inflammatory changes at the cellular and molecular levels.

CLINICAL RELEVANCE: Topical blockade of VLA-4 may be a novel therapeutic approach to treat the clinical signs and inflammatory changes accompanying dry eye disease.

Headline: Don't move to Tucson?!

OK so it wasn't exactly a headline, but this blurb from a newspiece on eye health made me chuckle for a moment when I thought of non-Tucsonians' reaction:

Living here can increase the risk of afflictions such as dry eye syndrome, which can cause stinging, burning, pain and redness in the eye.

Full article:
Keeping eyes healthy latest topic at science center

Newsblurb: Eyelash lengthening stuff by Allergan

Just a little heads up (again) about this. I think that people with dry eye are probably especially likely to consider ways to enhance their eye appearance that don't involve makeup... so beware that this could actually make your dry eyes worse.

UPDATE 2-Allergan drug lengthens eyelashes -US FDA staff

A drug from Botox maker Allergan Inc (AGN.N: Quote, Profile, Research, Stock Buzz) increased the length, thickness and darkness of eyelashes in a company study, U.S. drug reviewers said in a report released on Wednesday.

The analysis was prepared for a Food and Drug Administration advisory panel that meets Friday to evaluate the proposed cosmetic use of the drug, bimatoprost, now sold for treating glaucoma.

The panel of outside experts will consider if bimatoprost offers enough benefit to outweigh the risks of its use on the eyelashes, the FDA staff report said.

Four out of 137 patients who used the drug, which was applied daily along the upper eyelids, dropped out of Allergan's study because of mild or moderate eczema, dry eye, eye inflammation or dermatitis, FDA staff said.

Allergan, in a separate summary, said problems reported by users "occurred at a low frequency and were largely mild in severity, cosmetic in nature, and reversible." They included eye itchiness reported by 3.6 percent of patients, and eye irritation reported by about 2 percent of patients.

Gee, Allergan, I don't remember dry eye being cosmetic in nature.

Abstract: Intralase and dry eye

Typical. For FDA clinicals, of course we have to check both signs and symptoms because it is WELL KNOWN that there is a poor correlation between the two, but heaven forbid that anyone include assessment of symptoms in post refractive patients if they don't have to. JRS is probably the last ophthalmic publication I would expect to care about the distinction.

PURPOSE: To evaluate changes in comeal sensitivity and tear function following myopic LASIK with thin femtosecond flaps.
J Refract Surg. 2008 Nov;24(9):897-902
Barequet IS, Hirsh A, Levinger S.

METHODS: A retrospective study was performed to compare corneal sensitivity (filament), tear breakup time, and anesthetized Schirmer test preoperatively and at 1 week and 2 and 6 months postoperatively.

RESULTS: Seventy-two eyes of 38 consecutive patients (20 women and 18 men) who underwent LASIK for myopia or myopic astigmatism with thin femtosecond flaps (IntraLase femtosecond laser system and Technolas 217 PlanoScan V2.9992 or wavefront-guided Zyoptix 3.1 excimer laser) were evaluated. Preoperative mean corneal sensitivity was 5.3+/-1.5 mm, which decreased to 4.6+/-1.7 mm at 1 week, increased to 5.0+/-1.3 mm at 2 months, and returned to baseline values at 6 months postoperatively. Mean Schirmer score was 13.7+/-5.7 mm preoperatively and 12.1+/-5.1, 13.1+/-4.8, and 13.0+/-5.1 mm at 1 week and 2 and 6 months postoperatively, respectively. Mean tear breakup time was 7.7+/-2.6 seconds preoperatively and 7.8+/-3.5, 9.2+/-4.6, and 8.8+/-4.5 seconds at 1 week and 2 and 6 months postoperatively, respectively. No significant increase in fluorescein staining was observed throughout follow-up.

CONCLUSIONS: Reductions in corneal sensitivity and tear function tests were minimal after myopic LASIK with thin femtosecond flaps. Despite the relatively narrow hinge, the thin, uniform femtosecond flap does not appear to have an adverse effect on corneal sensitivity and dry eye signs at 6 months postoperatively.

Abstract: Radiation therapy for eyelid/conjunctiva cancers

The main reason this caught my eye was the remark in the conclusions that "the ocular side effects were relatively minor in most patients". That kind of thing always makes me wonder how they measured it, and whether the patients considered it minor.

Postoperative adjuvant external-beam radiation therapy for cancers of the eyelid and conjunctiva.
Ophthal Plast Reconstr Surg. 2008 Nov-Dec;24(6):444-9
Hsu A, Frank SJ, Ballo MT, Garden AS, Morrison WH, Rosenthal DI, Hatef E, Esmaeli B

PURPOSE: To outline the indications for and our experience with postoperative adjuvant external-beam radiotherapy (EBRT) in patients with eyelid or conjunctival cancers.

METHODS: Twenty consecutive patients with primary eyelid or conjunctival cancer treated with surgical resection followed by postoperative EBRT between January 2000 and September 2006 were included. The indications for postoperative EBRT, type and dose of EBRT, oculoplastic reconstructive procedures, timing of EBRT in relation to reconstructive procedures, and the ocular side effects of EBRT were recorded.

RESULTS: Sixteen women and 4 men ranged in age from 44 to 86 years (median, 64 years). The oculoplastic procedures included local flaps or direct closure of eyelid defect (12), tarsoconjunctival flap (6), full-thickness skin grafts (6), amniotic membrane grafts (2), other conjunctival reconstruction (2), tarsoconjunctival graft (1), and lacrimal stenting (1). The total radiation dose ranged from 26 to 63 Gy (median, 60 Gy). The indications for postoperative EBRT included aggressive histology, recurrent tumor, microscopic perineural invasion, advanced-stage disease, and microscopically positive or "close" margins. EBRT started 5 to 12 weeks (median, 7 weeks) after reconstructive procedures. The follow-up time ranged from 7 to 50 months (mean, 24 months). Thirteen patients experienced dry eye syndrome; 3 keratinization of conjunctiva; and 1 each blepharitis, trichiasis, radiation retinopathy/optic neuropathy, and exposure keratopathy.

CONCLUSIONS: Postoperative EBRT can be used as adjuvant therapy after surgical resection of eyelid or conjunctival cancers and may obviate more radical surgery such as orbital exenteration in some patients. The ocular side effects from EBRT were relatively minor in most patients.

Abstract: Varying the osmolarity of HLA

Compares hypotonic with isotonic HLA drops...

Bottom line, the hypotonic version felt better.
Cornea. 2008 Dec;27(10):1126-30
Troiano P, Monaco G.

Effect of hypotonic 0.4% hyaluronic acid drops in dry eye patients: a cross-over study.

PURPOSE: The aim of the study is to evaluate the short-term effects of 2 kinds of artificial tears, both containing 0.4% hyaluronic acid in an aqueous solution yet having different osmolarity, on the typical symptoms of patients suffering from dry eye and on the vitality of corneal and conjunctival epithelial cells.

METHODS: A cross-over, randomized, balanced, single-blind study involving 28 patients was divided into 2 treatment groups: group A (unpreserved 0.4% hyaluronic acid eye drops 300 mOsm/L) and group B (unpreserved 0.4% hyaluronic acid eye drops 150 mOsm/L). Both treatments were administered for 7 days, being dosed as a 1 solution drop 4 times daily. After a 1-day wash-out period, the patients in group A passed over to group B and vice versa.

RESULTS: Treatment with hypotonic solution gave better results in relieving symptoms, along with a statistically significant improvement (P < 0.001) in the state of the corneoconjunctival epithelium, than the isotonic solution. At the end of the study, 60.7% of the patients declared that they preferred hypotonic solution and only 10.7% preferred isotonic solution; the remaining 28.6% did not notice any difference between the 2 treatments.

CONCLUSIONS: By reducing the osmolarity of tear film, the hypotonic solution not only improves the characteristics of tear film and the vitality of the epithelial cells of the cornea and conjunctiva but also proves to be effective in reducing dry eye symptoms.

Abstract: MG diagnostics

Nice one. Presumably partly driven by a plug (no pun intended, single or double) for an MG paddle but all the same, I like seeing anything out there that will help get doctors hands-on with their patients' eyelids and also help them know what the heck to look for.

Meibomian gland diagnostic expressibility: correlation with dry eye symptoms and gland location.
Cornea. 2008 Dec;27(10):1142-7
Korb DR, Blackie CA

PURPOSE: To determine (1) if the number of meibomian glands yielding liquid secretion (MGYLS) is correlated with dry eye symptoms and (2) the mean number of MGYLS in the nasal, central, and temporal regions of the lower eyelid in a random clinical sample.

METHODS: Subjects presenting for routine eye examinations were recruited (n = 133; 90 females, 43 males; mean age = 50.3 +/- 14.7 years). The sample included symptomatic and asymptomatic individuals using the Standard Patient Evaluation of Eye Dryness questionnaire. Meibomian gland evaluations were performed using a standardized technique and diagnostic instrument.

RESULTS: The mean number of MGYLS in the lower eyelid correlated with dry eye symptoms, p = 0.0002. The mean numbers of MGYLS in each third of the lower eyelid were significantly different, p < or= 0.0001: temporal = 0.27 +/- 0.06, central = 2.14 +/- 0.13, and nasal = 3.10 +/- 0.15. The temporal third of the lower lid was 14 times as likely as the nasal third to have zero MGYLS; 86% of temporal versus 6% of nasal thirds had zero MGYLS.

CONCLUSIONS: This is the first report to document the following: (1) a correlation between the number of MGYLS in the lower eyelid and dry eye symptoms; (2) the number of MGYLS varies significantly across the lower eyelid, with the highest number of MGYLS in the nasal third and the lowest number of MGYLS in the temporal third of the lower eyelid; and (3) instrumentation to standardize diagnostic meibomian gland expression is desirable if not mandatory for the evaluation of meibomian gland function.

Drug news: Resolvyx set to start Phase I/II of RX-10045

Resolvyx announces completion of FDA review period for dry eye drug

Resolvyx Pharmaceuticals has announced that the 30-day review period by the FDA is now complete for an investigational new drug application supporting the use of RX-10045 for the treatment of ophthalmic diseases.

The opening of this investigational new drug (IND) application, submitted in early October 2008, allows Resolvyx to initiate its first clinical trial, which will be a placebo-controlled, Phase I/II study of RX-10045 in 200 patients with moderate-severe dry eye. The company will initiate this study before the end of 2008.

RX-10045 is an isopropyl ester pro-drug of the active Resolvin compound, RX-10008. Resolvyx said that it has conducted in vivo preclinical studies that have demonstrated that RX-10008 is effective in preventing the deleterious effects of dry eye as well as restoring healthy cell function.

In addition, RX-10008 has been shown to be highly effective in preventing clinical signs of dry eye, including decreasing corneal inflammation, reducing corneal epithelial damage and preventing loss of goblet cells (the cells responsible for maintaining tear film integrity).

Abstract: Cepan for demodex??

Thought a few of you would perk up your ears at this. I'd never heard of it, at least that I recall.

[Efficiency and application safety of Cepan cream. Observation of a new indication]
Przegl Lek. 2008;65(5):241-3
Stozkowska W, Raczyńska K

Cepan Cream has been applied in therapeutics for 20 years. This drug is used for topical treatment of burn scars and keloids as well as post-operative scars and contractures. Cepan produces a multidirectional effect. Cepan is well tolerated. Pharmacological property analysis of active ingredients, results of physical, biochemical studies and clinical estimation indicate that the evaluated preparation is both effective and safe. Lately, new information on Cepan effectiveness in eyelids inflammation caused by parasite Demodex folliculorum has been particulary interesting.

Abstract: Azasite vs. Erythromycin ointment

Sounds nice (if uninformative). I don't really know what to make of Azasite for bleph at this point. I've heard all kinds of views from reputable doctors, ranging from considering it a wonderdrug to reserving judgment to dismissing it as pure marketing ploy.

Use of azithromycin ophthalmic solution in the treatment of chronic mixed anterior blepharitis
Ann Ophthalmol (Skokie). 2008 Summer;40(2):68-74
John T, Shah AA.

We tested the efficacy of azithromycin ophthalmic solution for the treatment of chronic mixed anterior blepharitis. The findings suggest that patients with chronic mixed anterior blepharitis can be more effectively treated with azithromycin ophthalmic solution than erythromycin ophthalmic ointment. Patients treated with azithromycin ophthalmic solution show an extraordinary clinical response with shorter treatment duration.

Newsblurb: For the RCE patients out there...

If you think you never see RCE in the press, think again. I've seen two or three of these this year.

Red Wings' Cleary still battling eye injury

DETROIT -- Dan Cleary can't drive, and his depth perception still is a little off.

But he is doing his best to stay in shape while he recovers from an irritation in his left eye.

...Cleary has been bothered for six weeks by the irritation, which originally was caused by a scratched cornea. He scratched the cornea again against the Devils, and still isn't sure how he did it.

His eye was red after practice, and he had trouble keeping it open. He missed his fourth game Monday night, and he will be out at least three more by not traveling with the team.

Cleary said it's not an eye infection.

"I just got another scratch in the eye. I didn't know I had. It just got really bad (last Monday)," Cleary said. "Right now it's turned the corner, and I'm looking at another week. Doctor (Jayne) Weiss has been unbelievable. Without her and Kresgee Eye Institute, I would have been in rough shape."

Cleary said doctors can't heal the scratch and his vision at the same time, which makes his recovery difficult. The scratch will have to heal first, then the vision will improve with steroids and eyedrops.

Abstract: Drug delivery system

For those of you following novel drug delivery systems and 'time-release' type approaches, I thought this was rather interesting. I would guess that a concept like this is dependent on a healthy tear film, which would make it a no-go for delivering dry eye treatments, but who knows.

Mucoadhesive microdiscs engineered for ophthalmic drug delivery: effect of particle geometry and formulation on preocular residence time.
Invest Ophthalmol Vis Sci. 2008 Nov;49(11):4808-15. Epub 2008 Aug 8
Choy YB, Park JH, McCarey BE, Edelhauser HF, Prausnitz MR

PURPOSE: To test the hypothesis that mucoadhesive microdiscs formulated in a rapidly dissolving tablet can increase preocular residence time.

METHODS: Microparticles smaller than 10 mum in diameter were fabricated by emulsification with poly(lactic-co-glycolic acid) as a core material and, in some cases, poly(ethylene glycol) as a mucoadhesion promoter. To examine the effect of particle geometry, microparticles were also cut to have flat surfaces (i.e., microdiscs) and were compared with spherical particles (i.e., microspheres). In vitro mucoadhesion of microparticles was tested on a mucous layer under shear stress, mimicking the human blink. The resultant microparticles were also formulated in two dosage forms, an aqueous suspension and a dry tablet, to test the effect of formulation on the retention capacity of microparticles on the preocular space of rabbits in vivo.

RESULTS: Mucoadhesive microdiscs adhered better to the simulated ocular surface than did other types of microparticles. When a dry tablet embedded with mucoadhesive microdiscs was administered in the cul-de-sac of the rabbit eye in vivo, these microdiscs exhibited longer retention than the other formulations tested in this study. More than 40% and 17% of mucoadhesive microdiscs remained on the preocular surface at 10 minutes and 30 minutes after administration, respectively. Fluorescence images from the eye surface showed that mucoadhesive microdiscs remain for at least 1 hour in the lower fornix.

CONCLUSIONS: This study demonstrated that mucoadhesive microdiscs formulated in a dry tablet can achieve a prolonged residence time on the preocular surface and thus are a promising drug delivery system for ophthalmic applications.

Abstract: Cetuximab and blepharitis

[Blepharitis related to Cetuximab treatment in an advanced colorectal cancer patient.]
Arch Soc Esp Oftalmol. 2008 Nov;83(11):665-8

CASE REPORT: A 52-year-old woman with advanced colorectal cancer was referred to us for treatment of Cetuximab-related ocular side-effects.
Ramírez-Soria MP, España-Gregori E, Aviñó-Martínez J, Pastor-Pascual F

DISCUSSION: Cetuximab is a monoclonal antibody that specifically blocks epidermal growth factor receptor activity. It has recently been approved to treat some tumors such as metastatic colorectal cancer and some ORL cancers. Tolerance to it seems to be better than that to the classic chemotherapeutic agents. However it has several side-effects. Cetuximab-related eyelid toxicity has been recently described, though the pathogenesis has not yet been clearly established (Arch Soc Esp Oftalmol 2008; 83: 665-668).

Survey: Ophthalmologists apparently agree...

...that we need more and better treatments for dry eye, according to a study sponsored by Aton Pharma (the Lacriserts company).

Dry Eye Survey: Ophthalmologists Cite Treatment Limitations/Gaps in Treatment of Moderate to Severe Dry Eye

Nearly all of the ophthalmologists surveyed (94%) believe more treatment
options are needed for moderate to severe dry eye. While 80% feel current
therapies are effective for mild dry eye, only 33% feel they are effective for
moderate dry eye and 67% feel they are only somewhat effective or not very
effective. Only 5% feel current therapies are effective for severe dry eye,
while 56% feel they are somewhat effective and 38%, not very or not at all

Drug/Device news: EGP-437 enrolling for Phase II clinicals

EyeGate Pharma Enrolls First Dry Eye Patient in Phase II Clinical Trial of Lead Product EGP-437
Enrollment Marks Second Clinical Trial Initiation for EGP-437 in 2008

WALTHAM, MA, Nov 10, 2008 (MARKET WIRE via COMTEX) -- EyeGate Pharma, the leader in ocular drug delivery, a specialty pharmaceutical company using iontophoresis technology to safely and non-invasively deliver therapeutics to treat serious ocular diseases, today announced that it has enrolled the first dry eye patient in a Phase II safety and efficacy clinical study of EGP-437 (a combination drug/device). This patient enrollment marks the Company's second clinical trial initiated in the second half of 2008. In July, the Company initiated a landmark Phase II clinical study in severe uveitis, which represented the first U.S. study under an open IND to employ iontophoresis technology to deliver an active compound into the eye.

EyeGate is partnering with Ophthalmic Research Associates (ORA), a leading global clinical research and development organization, located in North Andover, MA. Over the past 30 years, ORA has played a central role in the development and FDA approval of more than 25 ophthalmic products.

"Dry eye is the most prevalent form of ocular discomfort and irritation, and currently has no cure and few treatment options to alleviate symptoms that only provide temporary relief. It is estimated that as many as 20 to 40 million Americans suffer from mild-to-moderate dry eye. Symptoms such as pain, light sensitivity, blurred vision, and irritation decrease the quality of life for patients and can ultimately lead to loss of function and blindness," commented George Ousler, Director of Dry Eye Research at ORA.

The Phase II study is a single-center, randomized, double-masked, placebo-controlled safety and efficacy study of two doses of a corticosteroid solution (EGP-437) over a period of three weeks in dry eye patients. ORA's proprietary Controlled Adverse Environment (CAE) clinical model is being used in this study to support the clinical development of EGP-437.

Drug news: Novel canine dry eye treatment

I thought this was rather interesting:

Vet Develops Implant to Treat Dog Eye Diseases
The biodegradable implant is designed to replace frequent eye drops.

Sinisa Grozdanic, DVM, an assistant professor of veterinary clinical sciences at Iowa State University’s College of Veterinary Medicine, has developed a new treatment method for canine eye diseases. One that is said to be more effective and reliable than using eye drops.

It involves implanting biodegradable medicine into the tissue surrounding a dog’s eye, a process that takes just a few minutes and is done with local anesthetic. The medicine releases gradually and treats the infected eye for about a year.

This is the first time the procedure has been tried to improve auto-immune corneal diseases that can cause pain, redness, inflammation, and other eye problems for canines.

Specifically, Dr. Grozdanic has been looking at how the procedure treats pannus, an inflammation of the corneal surface of the eye and the conjunctiva; keratoconjunctivitis sicca, also known as dry eye; and pigmentary keratitis, an inflammatory condition of the cornea characterized by abnormal pigmentation.

Abstract: Cyclosporine & dry eye

Ho hum....

Ciclosporin use in dry eye disease patients.
Expert Opin Pharmacother. 2008 Dec;9(17):3121-8
Ridder WH 3rd.

BACKGROUND: Dry eye disease is one of the most commonly encountered conditions in eye care, and inflammation is a frequent finding. Ciclosporin has long been used systemically to decrease the deleterious effects of inflammation. Ciclosporin is a calcineurin inhibitor that acts by primarily blocking the action of T cells, decreasing the release of pro-inflammatory cytokines, and preventing the apoptosis of goblet cells.

OBJECTIVE: This article reviews the clinical trials and safety profile of an ophthalmic preparation of ciclosporin in the treatment of dry eye.

RESULTS/CONCLUSION: Clinical trials have demonstrated that ciclosporin minimizes the signs and symptoms of dry eye disease and is not associated with any significant systemic or ocular adverse reaction.

Abstract: Tear film evaporation when wearing contact lenses

Nothing particularly new here....

Contact lens wear affects tear film evaporation.
Eye Contact Lens. 2008 Nov;34(6):326-30
Guillon M, Maissa C.

PURPOSE: The aim of the study was to measure tear film evaporation of both contact lens wearers (CLW) and nonwearers. The hypotheses tested were that (i) amongst CLW tear film evaporation was higher when contact lenses are worn and (ii) tear film evaporation of CLW was higher than nonwearers in the absence of contact lenses.

METHODS: Tear film evaporation rate was measured at 30% and 40% mean humidity. The subjects were divided into 3 groups: (i) CLW wearing contact lenses (n = 111 subjects or 222 eyes), (ii) CLW having not worn contact lenses on the day of the visit (CLW no CL n = 129 subjects or 258 eyes), and (iii) Non-contact lens wearers (NW) (n = 139 subjects or 278 eyes).

RESULTS: The rate of evaporation was similar for the right and left eyes at both humidities. The rate of evaporation was significantly higher for the CLW, than for both CLW no CL and NW. The decrease in the rate of evaporation between the dry (30%) and normal (40%) environmental conditions was significantly lower for the CLW than for the NW. Further, the evaporation rate was significantly greater for the CLW, even after 1 day without contact lens wear, than for the nonwearers.

CONCLUSIONS: The investigation demonstrates that the rate of evaporation is higher in the presence of a contact lens; the effect may be associated with tissue and/or tear film changes as it is, in part, still present 24 hours after contact lens wear. Wearing contact lenses in normal humidity conditions (40%) produces a greater evaporation than that experienced by non-contact lens wearers in low humidity (30%). This could explain the higher prevalence of dry eye complaints among CLW than amongst nonwearers. The study results support the hypothesis of increased evaporation as a contributing factor to contact lens induced dry eyes.

Abstract: Another Systane study

Geez, I've lost count of studies on Systane at this point.

Impact on ocular surface evaporation of an artificial tear solution containing hydroxypropyl guar.
Eye Contact Lens. 2008 Nov;34(6):331-4.
Uchiyama E, Di Pascuale MA, Butovich IA, McCulley JP.

OBJECTIVE: To determine whether any acute effects on evaporative parameters are produced when using a solution containing Hydroxypropyl (HP) (Systane) versus normal saline solution in the eyes of patients with Keratoconjunctivis Sicca at 30 and 60 minutes postinstillation.

METHODS: Randomized double-blinded placebo-control 2-period cross-over clinical trial. Twelve patients with a clinical diagnosis of Keratoconjunctivis Sicca were enrolled in this study. Aqueous tear evaporation was measured at baseline, i.e., before the application of drops on the eye, and at 30 and 60 minutes after instillation of one 40 microL drop of either the HP-Guar containing drop or normal saline on two separate days. Statistical analysis included descriptive data analysis and paired t test.

RESULTS: Hydroxypropyl-Guar resulted in a decrease in aqueous tear evaporation at 30 minutes postinstillation under 25% to 35% relative humidity (RH) (13.2% reduction, P=0.044) and 35% to 45% RH (10% reduction, P=0.028) conditions. The effect of HP-Guar at 60 minutes postinstillation also decreased aqueous tear evaporation but to a lesser degree. Normal saline solution produced no statistically significant increases and decreases of evaporation.

CONCLUSIONS: Aqueous tear evaporation contributes significantly to aqueous tear loss and is humidity dependent. An HP-guar containing solution decreased aqueous tear evaporation 30 and 60 minutes after application. The use of topical medication with known antievaporative effect may be beneficial in dry eye therapy. This effect may also be achieved in normal eyes or sub-clinical dry eyes when in low RH environments.

Abstract: Non-ophthalmologists treating dry eye

Treatment of dry eye disease by the non-ophthalmologist.
Rheum Dis Clin North Am. 2008 Nov;34(4):987-1000, x.
Foulks GN.

Physicians caring for patients who have Sjögren's syndrome often face a particularly difficult task in managing the dry eye that occurs with this disease. The discomfort produced by the condition and the fluctuation of vision attendant to tear film instability are often the most annoying of the clinical symptoms. The understanding of dry eye disease in both its clinical expression and underlying etiopathology has expanded over the past 10 years with implications for management and therapy. The array of potential treatments both topical and systemic has evolved to provide a much more targeted and effective arsenal from which the clinician may choose.

Newsblurb: Boston Sclerals in Houston

News coverage of Boston Scleral satellite in Houston:

Custom-made contact lenses benefit patients with corneal diseases

HOUSTON -- (October 31, 2008) -- Ophthalmologists at Baylor College of Medicine in Houston can now improve impaired vision of patients with damaged or transplanted corneas who cannot wear conventional contact lenses.

"There is a large group of patients who we cannot fit with conventional contact lenses, including trauma patients, patients with irregularly shaped corneas, severe dry eye or bad outcomes from Lasik surgery," said Dr. Stephen Pflugfelder, professor of ophthalmology at BCM and director of the Boston Ocular Surface Prosthesis clinic at the Baylor Eye Clinic. "This remarkable technology allows us to provide a custom-fit, prosthetic, oxygen-permeable contact lens that vaults over the cornea and improves eye sight."

Dr. Anisa Gire, therapeutic optometrist at the Baylor Eye Clinic, will begin fitting patients at the Baylor Eye Clinic at the Medical Building on the McNair Campus of BCM when it opens Nov. 4.

"We are proud to be one of two centers outside of Boston to offer this lens," said Dr. Dan B. Jones, chair and professor of ophthalmology at BCM. "It will be a major resource not only for patients who need the lens, but for the community and area ophthalmologists who previously had to refer patients to Boston to be fitted for the lens."

Abstract: Radiation and lacrimal glands

Identifies a direct relationship between radiation treatment and reduced Schirmer scores.

Lacrimal Gland Radiosensitivity in Uveal Melanoma Patients.
Int J Radiat Oncol Biol Phys. 2008 Oct 27. [Epub ahead of print]
Muller K, Nowak PJ, Naus N, de Pan C, Santen CA, Levendag P, Luyten GP.

PURPOSE: To find a dose-volume effect for inhomogeneous irradiated lacrimal glands.

METHODS AND MATERIALS: Between 1999 and 2006, 72 patients (42 men and 30 women) were treated with fractionated stereotactic radiotherapy in a prospective, nonrandomized clinical trial (median follow-up, 32 months). A total dose of 50 Gy was given on 5 consecutive days. The mean of all Schirmer test results obtained >/=6 months after treatment was correlated with the radiation dose delivered to the lacrimal gland. Also, the appearance of dry eye syndrome (DES) was related to the lacrimal gland dose distribution.

RESULTS: Of the 72 patients, 17 developed a late Schirmer value <10 mm; 9 patients developed DES. A statistically significant relationship was found between the received median dose in the lacrimal gland vs. reduced tear production (p = 0.000) and vs. the appearance of DES (p = 0.003), respectively. A median dose of 7 Gy/fraction to the lacrimal gland caused a 50% risk of low Schirmer results. A median dose of 10 Gy resulted in a 50% probability of DES.

CONCLUSION: We found a clear dose-volume relationship for irradiated lacrimal glands with regard to reduced tear production and the appearance of DES.

Study: Systane and corneal staining

Marketing study straight from the source...

Corneal staining reductions observed after treatment with Systane(R) Lubricant Eye Drops.
Adv Ther. 2008 Nov;25(11):1191-9.
Christensen MT. Alcon Laboratories, Ltd., Fort Worth, Texas

INTRODUCTION: Because of the added emphasis on ocular surface damage included in the Dry Eye Workshop's revised definition of dry eye, an evaluation of corneal staining reductions was conducted for propylene glycol/polyethylene glycol 400-based artificial tear drops (Systane(R) Lubricant Eye Drops; Alcon Laboratories, Fort Worth, TX, USA). METHODS: An analysis was conducted on the percent change from baseline in mean corneal staining scores as reported in two previously published, randomized, double-masked, 6-week clinical studies of Systane. A descriptive comparison was also made between the outcome of the composite analysis and data obtained for Optivetrade mark Lubricant Eye Drops (Allergan, Inc., Irvine, CA, USA). Finally, results were reviewed for an open-label study that investigated corneal staining over a 5-week period after patients discontinued Systane therapy. RESULTS: The composite analysis included 107 Systane-treated patients. The results showed that Systane consistently reduced corneal staining at each visit; the percent change from baseline to day 42 (exit) was 47.1% (P<0.0001). After discontinuing Systane, immediate and significant increases in corneal staining were reported by 20 patients, with an overall increase from baseline to day 35 (exit) of 195.0% (P<0.0001). CONCLUSION: Evaluations of sum corneal ocular staining scores provide clinically meaningful evidence of dry eye severity, and are an important indicator of dry eye disease progression. The results of the composite analysis of two peer-reviewed studies indicate that Systane significantly reduced corneal staining (P<0.0001), indicating a reduction in the severity of dry eye. Finally, discontinuation of Systane results in a rapid increase in corneal staining that further confirms Systane's ability to maintain ocular surface health.

Drug update: Ecabet Sodium

According to a 10/30 press release, results from ISTA's Phase II clinicals on Ecabet Sodium will be released this quarter.

Another resolution


My second resolution is this: I will not get discouraged and quit just because so far I've been an abysmal failure on the first one.

The stack of news reports and studies is getting higher. But the list of move-in tasks and things this house needs doing to it to make it livable is gradually getting a little bit shorter.

The sequel to my original plumbing nightmare set me back a bit, I must admit.

I'm sitting here at the computer (getting ready to blog, believe it or not) when I hear a cataract of water pouring into the furnace room. I rush in and see water pouring out of the pipes and through the floor above. Rush upstairs and find water pouring out of the toilet. Where the blankety blank is the main water cutoff? Panicky call to property manager. She doesn't know, but the neighbor to the north does. Panicky call to Budget Rooter (who know us VERY well by now). Grab Chaidie and run over the field to the neighbor's. Big mean dog chases us off property. That dog knows EXACTLY where the property line is and without body armor I'm not going to argue with him. Run back home. Grab a trash can and haul it downstairs to place at the point where the water is the worst. Upstairs, throw a dozen towels on the bathroom floor to keep the water from escaping to anywhere with carpet. Call property manager again, she can't locate owner. Run out to well house. I don't know what the faucet there does (learned later it was just the pressure tank... I'm still well illiterate) but I twist it all the way to the right. Run back, throw down more towels by bathroom, run down to furnace room, empty the (full) buckets, block the water from escaping to other rooms... Budget Rooter calls to say a guy is on the way, the doorbell rings as soon as they hang up, and the water pressure drops off. Hurray!

The plumber gets it fixed temporarily. Comes back the next day and makes no progress in two hours after snaking the pipes a couple different ways and sending in a camera. Calls in a colleague who has a better camera. They eventually come up with a brillo pad or something like that that they think was stuck in an awkward corner.

If it sounds awful, it's really not. I am so, so, so in love with this place. I ordered a ton of seeds yesterday, and I've been devouring books about sustainable farming. (More about those another time.)

So anyway, I'm sitting here at my desk (downstairs... this is a 2-story house built on a hill) and looking out onto the orchard blanketed in 3" of snow that fell Saturday night. It was 19 degrees at breakfast time this morning... worst arctic blast since 1990 in our temperate climate here. Chaidie is having an absolute ball playing in the snow and you may imagine.

When I think of everything stacked up - haven't even looked at a bill in the last 3-4 weeks we've been so overloaded, and lot of other business matters, not to mention trying to get some curtains on our windows to help keep the heat in and a thousand other little house projects... well it's a little overwhelming, but one foot in front of another, right?

Have a great day and week everyone.

Wednesday, December 10, 2008

Reminder: March 7th, Long Beach CA - Dry Eye Conference

Just a reminder that the Sjogrens Syndrome Foundation is hosting a dry eye conference on March 7th at the Marriott in Long Beach, California.

From the Foundation:

National Dry Eye Patient Conference

March 07, 2009 * Long Beach Marriott * Long Beach, California
10am – 4pm (includes lunch)

Please join us at this patient conference where you will learn about managing your dry eye symptoms, discover potential causes of your dry eye as well as hear about different treatment options.

We have invited some of the leading dry eye experts from around the United States to present on an array of topics. Presentation topics will include:

- Management and Treatment of Dry Eye
- Contact Lenses for Dry Eye Patients
- What is Causing Your Dry Eye?
- Cataract & Lasik Surgery for Dry Eye Patients
- Dry Eye Research Update

Register today by calling 1-800-475-6473 or by returning the form below.

To get the registration form, please visit The Dry Eye Zone - you'll see it near the top.

A resolution


Nothing quite like that sinking feeling when I look at the long list of new studies, newsclips and so on that are on my list of things to cover in my blog. It goes from a slope to a hill to a mountain before I know it.


My new resolution is to post something in the blog every day. Whether or not it's on dry eye. That way at least I can keep myself in the flow and, who knows, maybe even keep up with dry eye news better.

Thanks for your patience everyone.

Monday, December 8, 2008

On a personal note...

Eek! It's been, what, 3 weeks this time since I wrote a Dry Eye Bulletin? More than that since I updated the blog, for sure. And this time, it's not just because of my usual chronic behindness... it's a special brand of behindness, called MOVING.

Yes, again!

Only, this time, the destination is actually worth the pain of moving.

A little background: Those of you who have been around The Dry Eye Zone for a few years know that we moved (family and business) from Florida to Washington State back in 2006 in order to be closer to family. I grew up in Seattle, but lived away in various places (Greece... California... England... Florida) most of my adult life. And since I'm one of many, many people with a house they can't sell in Florida right now, we've been renting a townhome. And since our lease just expired and the complex was about to jack our rent up 25%... and since as many of you know we've been having some financial struggles due to my husband's health problems... that was a no go. So I went hunting for a rental home.

And by a miracle, we found this gem:

It's an old farmhouse in Poulsbo on 5 acres. With good soil, a lovely orchard - apple, pear, plum, and hazelnuts - tidy fields, and two outbuildings in good condition. The house is very roomy, nicely laid out, and in fact I think it's bigger than any we've owned or rented before. The outbuildings are great, and altogether it's plenty big enough to both live in and run the business from. The property is absolutely wonderful... I've always dreamed of this sort of thing and it never occurred to me I could RENT such a thing. Best of all, we started the lease in November, so we can garden to our heart's content without worrying that we'll lose a year's harvest if/when the owners decide they want to use the property. And believe me I plan to garden like crazy in 09.

Chaidie, my 6-year-old, is in HOG HEAVEN. Apple trees to climb, dirt to dig in, the prospect of getting our own chickens shortly (maybe even turkeys)... what more could a kid want?

I think I said old farmhouse. It is, er, showing its age. As a matter of fact, shortly after we moved in, one floor collapsed (thankfully an isolated problem in an addition, not the original structure), all the plumbing totally backed up (had to get the whole thing dug up and a clean-out added to the piping) and the fan on the (wood-burning!) furnace conked out. It was about that time I got laryngitis.

But the owners are very responsible and almost all of that is already fixed - just waiting on that fan (she said, typing with numb fingers!).

The interior is not exactly in great shape and I'm sure I'll be busy painting next year but I am just so thrilled with this place! I thought it was going to be years before we could live on some property and I just am so thankful for the opportunity we have to use land like this even though we can't buy. We're just 10 minutes from downtown Poulsbo, so still handy to everything we need. My husband is staying for a little while with his family in Greece who are kindly giving me a little breather on caregiving but when he comes back I know that he is going to love it.

Wednesday, November 5, 2008

Diagnostics news: Occulogix submits 510(k) for TearLab

OccuLogix Submits 510(k) Premarket Notification for the Tearlab(TM) Osmolarity System

OccuLogix, Inc. (NASDAQ: OCCXD)(TSX: OC) announced today that its subsidiary, OcuSense, Inc., has submitted its 510(k) premarket notification to the US Food and Drug Administration (the FDA) for clearance to market the TearLab(TM) Osmolarity System and the TearLab(TM) Osmolarity Test Card in the United States.

As previously disclosed, the TearLab(TM) system recently obtained CE Marking and is currently being sold and marketed in five European countries through exclusive distributor agreements. In the United States, prior to 510(k) clearance from the FDA, the system is available for research use only.

Clinical Validation

The regulatory application included a study that validated the performance of the TearLab(TM) Osmolarity System when performed in physician office laboratories (POL) by health care professionals using human tear fluid collected from volunteer subjects. The study looked at:

- Usability

- Safety

- Clinical performance

The study involved three sites and enrolled 234 patients. The Company expects to release top-line data from the study at the American Academy of Ophthalmology (AAO) and European Society of Ophthalmology (SOE) 2008 Joint Meeting in November.

Study: Collagen bandage lenses

Suggesting that these may be a noticeable improvement on classic bandage lenses:

Clinical evaluation of succinylated collagen bandage lenses for ophthalmic applications.
Ophthalmic Res. 2008;40(5):257-66. Epub 2008 Apr 25.
Hadassah J, Prakash D, Sehgal PK, Agarwal A, Bhuvaneshwari N.

AIM: To study whether succinylated collagen bandage lenses (SCBL) prepared from modified bovine collagen (succinylated collagen) can replace other bandage lenses presently employed to treat various corneal conditions like filamentary keratitis, dry eyes, recurrent corneal erosions, foreign body removal and epithelial trauma. METHODS: This observational case study included 32 patients (22 female and 10 male): 8 patients for filamentary keratitis (25%), 10 patients for dry eyes (31%), 4 patients for recurrent corneal erosions (13%), 7 patients for foreign body removal (22%) and 3 patients for epithelial trauma (9%). Their eyes were evaluated for biocompatibility, in vivo transparency, patient comfort, corneal fit, best corrected visual acuity (BCVA), tear fluid level and dissolution rate of SCBL. This was carried out over a 24-hour period of time. RESULTS: SCBL exhibited good transparency and remained transparent throughout the period of study (between 0 and 24 h) in the eyes of patients. SCBL did not cause any irritation, discomfort and foreign body sensation in the eye and eyes remained comfortable throughout the experiment. BCVA in the control group of patients was 1.00 (20/20). Mean (+/-SD) BCVA before inserting SCBL (in decimal equivalent) was 0.31 (20/60) +/- 0.18 (range 0.1- 0.66). BCVA (+/-SD) changed to 0.25 (20/80) +/- 0.18 4 h after the application of SCBL and 0.27 (20/70) +/- 0.18 24 h after the application of SCBL, with a safety index of 1.20. The mean (+/-SD) tear fluid level before application of SCBL was 11.9 +/- 5.39 h (range 3-24 mm) and changed to 13.9 +/- 5.68 h (range 5-28 mm) after 4 h of application of SCBL and 15.9 +/- 5.72 h (range 7-30 mm) after 24 h with a safety index of 13 mm. The mean (+/-SD) dissolution rate of SCBL in the control group of patients was 17.8 +/- 8.65 h (range 10-24 h) and the mean (+/-SD) dissolution rate in the experimental group was 22.2 +/- 9.29 h (range 10-24 h). We report the use of SCBL in various corneal conditions. CONCLUSION: The present study showed that SCBL has complete corneal fit and good comfort in human eyes. Transparency was maintained for a longer period along with fair visual acuity and improvement in tear fluid levels. The disadvantages of other bandage lenses presently used to treat various corneal conditions could be overcome by the use of SCBL lenses.

Inspire update on Prolacria (diquafosol)

Inspire initiates special protocol assessment process for dry eye trial

Inspire Pharmaceuticals, a biopharmaceutical company, has submitted a clinical protocol and request for special protocol assessment to the FDA for a pivotal Phase III environmental trial with Prolacria for the treatment of dry eye disease.

The protocol is based on information from a detailed analysis of the overall Prolacria clinical trial data to date, including Inspire's Phase III trials and recently completed pilot trial, and consultation with the FDA, Allergan, Inspire's corporate partner, and other dry eye experts.

After detailed analysis, Inspire determined that designing and conducting a further environmental trial was a more appropriate course than further studies of Prolacria in a controlled adverse environment.

Allergan, dearest, you have really outdone yourselves this time

By unamimous vote of the membership of Dry Eye Talk, the prestigious Cheesiest Pharmaceutical Marketing Effort of the Year award goes to whoever in Allergan's marketing department came up with an idea which if it weren't so simply demented would be even more offensive:

The Dry Eye Book Club.

Read it and weep.

Honestly... sponsoring someone to write a tear-jerker as a way to "raise disease awareness" (a/k/a sell more drugs)?

Inviting people to join "The Dry Eye Book Club" - and when they click on the link, redirecting them to registration for the Optive Frequent Buyer program - which includes requirements like joining all the marketing lists?

I simply could not believe this when I saw it. I think if our members weren't so darned desperate, some of them would be throwing away their Restasis in protest.

Seriously, Allergan, if anyone out there is listening, here are just a few of my personal objections to this ad:

1. The whole idea insults the intelligence of the average human being and especially women.

2. If you're going to put a human face on dry eye, make them at least pretend to have REAL dry eye. It's an insult to the rest of us to suggest that someone whose most serious complaint is that she uses artificial tears "up to 5 times a day" suffers from chronic dry eye. For heaven's sakes, our DryEyeZone members would give their right hand to be able to survive on 5 artificial tear doses. Many use audio books because they can no longer read - tear-jerkers or otherwise.

3. Artistic license is fine in marketing but let's not stray quite that far from medical facts! We all know that the reflex type tears that we get from irritants or emotion are different from the balanced basal tears we so desperately need.

4. Choosing as the professional face for this ad a physician best known as a pioneer in refractive surgery... er... no offense whatsoever to Dr. McDonald who enjoys an excellent reputation, but A, did it never occur to you HOW some of us got our dry eyes?

Please, please scrap this nonsense and go back to classic infomercials.

Industry news/gossip: Restasis inventor lashes out

This tidbit reaches way back into the past of Restasis, when a professor at the University of Georgia first put cyclosporin into a solution to treat canine dry eye 20+ years ago.... Now that Restasis is a blockbuster drug for Allergan, there is some unhappiness out there about how the university where it all started has shortchanged itself and the inventor of the longterm rewards.

UGA research royalty deal sours

...UGA officials expect royalty and licensing income to set yet another record next year, mainly because of a $10 million payment due from the global pharmaceutical company Allergan....

But the research foundation's payments from the pharmaceutical company would be millions more if inexperienced UGA officials had not caved in to tougher negotiators from the drug company, according to the former UGA faculty member whose invention provided the basis for Restasis....

More than two decades ago, [Renee] Kaswan thought of something no one had tried before - putting the immunosuppressant drug cyclosporin into a solution so that it could be applied to the eyes of dogs suffering from dry eye....

Kaswan's second idea was even bigger than Optimmune, the dog dry eye drug. Why not use basically the same solution to cure dry eye in humans?

The U.S. Food and Drug Administration approved the new drug for human use in 2002. And in 2003, Allergan began marketing and selling the drug, which it called Restasis....

New product: Tranquileyes "stye care kit"

"Stye care kit" a/k/a single-eye Tranquileyes....

Click for details or to purchase in The Dry Eye Shop

What it is

This is Eye Eco's latest twist on the Tranquileyes theme. Here's what the kit consists of:
- One Tranquileyes eyecup
- Eye cushion and moisture pad (unlined type)
- Two Thermoeyes heat inserts
- Simple elastic band to hold eyecup on
- Mesh washbag for the moisture pad

How it's used

First, if you're new to Tranquileyes and Thermoeyes, I suggest you read up on both first.

The new twist here is using the thermoeyes on top of the moisture pad rather than underneath, so as to apply heat directly to the eyelid. Of course, some few of you are already doing this, with or without the goggle, because it's the only non-microwave, multi-use heat device available and suitable (so far as I know... let me know if there's any hidden gems out there I haven't heard of).

This was packaged specifically with styes in mind BUT I think there will be a variety of applications for them. Here are a few suggestions just off the top of my head:

Stye treatment (that's what the directions in the kit are for): Use the heat insert on top of the moisture pad. Since it has the regular (thick) moisture pad instead of a thermopad, this will put more pressure on the lid and hold the heat right where you want it.

Meibomian gland dysfunction, one eye at a time: What this single-eye kit will allow you to do is multitask... do heat on one eye while you're using the other eye.

Daytime rejuvenation, one eye at a time: Do your eyes get more and more painful as the day progresses? For a lot of people, giving your eyes a 20-30 minute break at some point during the day can make a huge difference - set the clock back, so to speak - and many use the tranquileyes goggle for that purpose. But not everybody can afford that much "downtime". If you're in an environment where you don't mind being seen with this, it would allow you to give one eye a moisturizing break while you continue working or doing other things. Then just switch eyes....

Night protection for a single eye. Now mind, I have not tried this myself so I cannot attest to how well it will stay on if you're tossing and turning. Usually if people only need to treat a single eye, I suggest that they get the full goggle and (if they want) remove the moisture pad from one side. But this is another alternative, and may be attractive especially for those who do not want to wake up "blind" in the middle of the night.

I'd love to have feedback on this and if you come up with other uses for it please let me know so I can share it with others here!

New product: MEGS (Micro-Environment Glasses)

The long-awaited MEGs are here! To see more pictures, get detailed information or purchase them, please visit the Seefit website.

The makers were kind enough to send me two pairs to try out. I've spent a fair amount of time wearing them and want to share my experience thus far.

Basic description: MEGs are the first commercial moisture chamber eyewear that can take high prescriptions. They are basically a simple pair of rimless glasses with a flexible, rubbery shield built all around them. You can purchase them with a "plano" (no prescription) lens or a "demo" lens to be replaced with prescription lenses that your local optician can put in them. (Please note that if you have a high prescription you may need to shop around for the right optician.)

Frame fit: I have a ladies small and medium. They both fit me fine and I could wear both all day without any discomfort. I tried the small pair on my daughter (6yo). They're too big on her :-) but they sure look cute.

Aesthetics: They are not as discreet as a really well done custom moisture chamber, but for indoor use they're far more 'aesthetically pleasing' than wearing foam-lined sunglasses or motorcycle goggles. Personally, I would not hesitate to wear these in an office environment if I needed to. Will others notice? Yes, but crucially, they are not distracting and unlike almost all alternatives they won't interfere in any way with eye contact.

Shield/Seal fit: Within the constraints of this type of product, I think they really did quite a good job.

Now, about those constraints. First, this is not a foam-lined product. The closest equivalent to this product would be the custom-cut Eagle Vision moisture chamber or custom chambers some optometrists are able to make. In a non-custom product like this where it has to fit all kinds of people, of course the shield can't go right to your skin, but it gets pretty close, at least for me, on the top and sides. Second, how close to the skin the shield can get is limited by the need to keep an effective vent to prevent fogging, which is a problem for any kind of moisture chamber. On me, and my sister who tried them for me (for reference, I have a round face and she has a much more slender oval face) there is a large gap at the bottom of the MEGs. It's my guess that this their way of minimizing fogging. All things considered if I'm going to have a gap, the bottom is where I'd want it.

What this means is that while it will provide good protection for a great many people, it will not be adequate for some people. Here's how I look at it: If you currently literally cannot get through the day without Panoptx style completely sealed glasses or custom moisture chambers, MEGs will probably not be an alternative for you. But that leaves a lot of people whom it WILL probably help a great deal. Here are some of the best uses for them I can think of:

1) People who WOULD be wearing moisture chambers if they could only get them with their glasses prescription.

2) People who WOULD be wearing moisture chambers at work if only they weren't so bulky or distracting and didn't interfere with eye contact.

3) People who CURRENTLY wear moisture chambers as much of the time as they can but leave them off specifically for aesthetic reasons in some circumstances.

4) People who have dry eye symptoms that are inadequately addressed with their current treatments, experience a lot of discomfort, and have never considered moisture chambers because... well... they can't face the idea of wearing goggles, or they don't think they're badly enough off for moisture chambers, etc.

Now that's just addressing the sorts of people we have most often on DryEyeTalk. Then of course there's a far larger audience that I think would benefit from these - namely, just about anybody working at a computer, especially the ones that are still wearing contact lenses.

Shield/seal efficacy: Sigh. On this, the single most important question, I can't give any useful feedback except to the extent it can be inferred from the seal fit description. I wear scleral lenses during the day, which keep me so comfortable that I wouldn't notice the difference of a moisture chamber indoors. I also rely on sclerals to see so I can't just leave them out for a day to give the MEGs a trial run. Sorry... Those of you who get the MEGs, I sure would appreciate it if you would post your comments on performance here and/or on DryEyeTalk.

Colors, styles, sizes: It comes in men's, ladies' medium and ladies' small. The shield is available in several colors including black, brown, grey, red, blue.

Price: $249. Yes, I know, it's steep, especially when you factor in the cost of prescription lenses, but it's not more than a pair of prescription Panoptx. Bear in mind that there are very high costs associated with developing this kind of product. In my opinion, moisture chambers are an important investment for chronic dry eye patients, and while I can't tell you which will be best for you, this one definitely deserves consideration.

p.s. No, that's not me in the picture... I stole the pic from the website.

Monday, October 20, 2008

Drug news: Argentis update

Meanwhile, Argentis is trucking right along with its hormonal treatments, hoping to get their Phase II clinical trial complete next year. (Don't get too excited yet... target market entry date is 2013. But some of you might be interested in participating in their Phase III trials when those get going, and that's probably just a year and a half off.

Momentum revs up for arGentis
Pharmaceutical firm in fast lane for clinical trials

arGentis Pharmaceuticals LLC is gaining momentum to get its first two therapies to the marketplace with a $10 million-$12 million capital campaign, new paths for clinical trials and a renowned business accelerator firm to help it find a drug development partner.

The Memphis pharmaceutical company is now negotiating with a clinical research organization to begin a Phase II trial of its dry eye therapy. That trial would take six weeks and company officials are hoping to conclude it in 2009. It would be followed by a lengthier Phase III trial. The therapy is projected to hit the market in 2013.

Drug news: Alcon's latest

Finally!!! It's about time we saw some Alcon dollars in the dry eye drug research world.

First, we've got cilomilast, which I've never even heard of in this context. Alcon are licensing it from GlaxoSmithKline for ophthalmic indications.

Then, we've got a closer relationship with Origenis:

Alcon expanded its existing drug research alliance with Origenis with a focus on the discovery and development of the small molecules that might one day have a role in the treatment of eye diseases.

Here's the whole article if you're interested:

Alcon Pads Eye-Disease Pipeline through Deals with GSK and Origenis

Newsblurb: Dry eyes in Ireland

First we had a big wave of dry eye publicity in the US where it seemed every slow news day had some sort of minimally educational article about dry eye and how to treat it, or at least how to line the pockets of a pharmaceutical company. Now we're seeing articles now and then in Europe and Asia on a regular basis. Here's one example:

Treat your eyes - take a screen break

eatment in eye clinics as a result of working on computers for long stretches.

Researchers at the University of Ulster showed one of the most common complaints is dry eye, which can affect large numbers of people but particularly those who work at computers indoors, in air-conditioned environments.

Johnny Moore, consultant ophthalmic surgeon, advises people to pay attention to the positioning of the computer and also to check out the humidity within the workplace or office.

"It is important that the user's seat and PC screen are adjusted to the correct height," he says. Other points to note include:

- Make the screen a bit duller as it makes it easier to read.

- People blink at least half as much as they normally do when looking at computer screen. The advice is to remember to blink and every now and then close your eyes for a few seconds.

- Every 10 minutes fix on an object 10 feet away for 10 seconds.

- Instead of reading long reams of text on the computer it may be better to print it off rather than having to concentrate for a long time on the screen.

- When you're working at your computer screen, stop every hour and take a two-minute break.

During this time, lie back in your chair and close your eyes. This will help to moisten and re-lubricate your eyes so they feel less dry and irritated.

Other advice is keep well hydrated in the modern, air-conditioned environment.

Researchers at the University of Ulster are currently undertaking a phase three clinical trial for a new drug for dry-eye treatment. Ulster is one of 30 centres across Europe involved in the research.

I wonder if Dr. Moore has any suggestions when his patients confirm that the humidity in their office has dropped into single digits....

Abstract: Vitamin A vs. Restasis for dry eye

...And it's a tie!


Both Vitamin A and Restasis appear to have improved everything EXCEPT symptoms. (Oops, I take that back, sounds like staining didn't improve either.)

Am J Ophthalmol. 2008 Oct 8.
A Comparison of Vitamin A and Cyclosporine A 0.05% Eye Drops for Treatment of Dry Eye Syndrome.
Kim EC, Choi JS, Joo CK.

PURPOSE: To compare the efficacy of vitamin A (retinyl palmitate) and cyclosporine A 0.05% eye drops in treating patients with dry eye disease. DESIGN: Prospective, randomized, controlled, parallel group study. METHODS: A total of 150 patients with defined dry eye disease participated (50 in each treatment group). In three identical clinical trials, patients were treated twice daily with cyclosporine A 0.05%, four times daily with retinyl palmitate 0.05%, or with no eye drops. Adjunctive treatment with preservative-free artificial tears was undertaken four times daily in all groups. Corneal fluorescein staining results, Schirmer tear test (without anesthesia) results, tear film break-up time (BUT), dry eye symptom score, and impression cytologic analysis results were obtained before treatment and at the first, second, and third months after initiation of treatment. RESULTS: Both vitamin A eye drops and topical cyclosporine A 0.05% treatments led to significant improvement in blurred vision, tear film BUT, Schirmer I score results, and impression cytologic findings in patients with dry eye syndrome (P < .05). CONCLUSIONS: Both vitamin A eye drops and topical cyclosporine A 0.05% treatments are effective for the treatment of dry eye disorder.

Abstract: Improving corneal topography on a dry eye

This study discusses a method for improving corneal topography accuracy when the tear film is too unstable to get a reliable result otherwise. This sounds like something that would be particularly useful for refractive surgery patients who have ablation irregularities and dry eye. The authors also mention this technique may later be useful in examining the tear film itself.

Estimating corneal surface topography in videokeratoscopy in the presence of strong signal interference
IEEE Trans Biomed Eng. 2008 Oct;55(10):2381-7. Links.
Alonso-Caneiro D, Iskander DR, Collins MJ.

Videokeratoscopy techniques rely on a number of factors in order to achieve accurate estimates of corneal surface topography. Good tear film quality, minimal reflections from eyelashes, and minimal eye movements are essential for corneal topography estimates to be reliable. However, in practice, these ideal conditions may not always be fulfilled, especially in cases of subjects diagnosed with dry eye syndrome, having narrow palpebral apertures, long eyelashes, or nystagmus (uncontrolled eye movements). Such nonoptimal conditions of image acquisition result in poorer estimates of corneal topography. The aim of this paper was to devise a technique that would provide more accurate estimation of corneal topography in such situations and particularly when the source of signal interference is strong. This was achieved by developing a set of algorithms that extract the interference from the acquired raw videokeratoscopic image and filter the topography according to the interference location. The experiments carried out with test surfaces and real corneas showed that this new technique leads to a significant improvement in the topography estimator. Additionally, it is an interference indication procedure that, in the future, could be used for the purpose of tear film quality estimation.

Abstract: Dry eye and cataract surgery

Good points... enough that I'll forgive the poor translation even.

[Not to ignore the dry eye of cataract patients after surgery]
Zhonghua Yan Ke Za Zhi. 2008 Apr;44(4):291-2.

Sun XG, Shi YY, Zhang C.

Dry eye syndrome following cataract surgery was concerned about recently. Two kinds of dry eye were clinically observed after cataract surgery, early dry eye and chronic dry eye. Most cases of early dry eye, who usually had the normal lacrimal secretion before surgery, were reversible and involved in some of factors associated with surgery and post-surgery medication. But most cases of chronic dry eye, who have abnormal lacrimal secretion or "borderline state" of lacrimal secretion test before surgery, may suffer from the ocular surface diseases related to irreversible dry eye disease. It is significantly important for maintaining of the ocular surface stability and recovery of vision acuity after cataract surgery to do early diagnose and promptly manage the dry eye syndrome.

Abstract: More on contact lenses

Companion study to the previous, examining more signs in contact lens wear.

Mucins and ocular signs in symptomatic and asymptomatic contact lens wear.
Optom Vis Sci. 2008 Oct;85(10):E930-8.

Berry M, Pult H, Purslow C, Murphy PJ.
University of Bristol, Academic Unit of Ophthalmology, Bristol, United Kingdom.

PURPOSE: Lid wiper epitheliopathy (LWE) and lid parallel conjunctival folds (LIPCOF) are related to dry eye symptoms in contact lens wearers. Both clinical signs are assumed to be related to mechanical forces during blinking. As the mucus layer is a protector of the ocular surface tissue, this study investigates whether any alterations of mucins are detectable comparing symptomatic and asymptomatic soft contact lens wearers.

METHODS: Comfort was evaluated using the Contact Lens Dry Eye Questionnaire. Corneal staining, LWE, and LIPCOF were assessed in the right eyes of 50 (19 men, 31 women; mean age, 32.1 +/- 11.4 years) experienced lens wearers. The tear film was sampled using Schirmer strips pressed onto the temporal conjunctiva and from harvested contact lenses. Mucins were assessed in dot-blots and Western blots after electrophoresis on 1% agarose or 4 to 12% NuPAGE Gels. Non-parametric analyses were used to study differences between groups and correlations between objective tests, mucins, and symptoms.

RESULTS: Thirty-one subjects were classified asymptomatic and 19 symptomatic by the questionnaire. LWE and LIPCOF were significantly increased in the symptomatic group (p < 0.035). MUC5AC reactivity was significantly decreased in symptomatics (p = 0.050). MUC4 was correlated to temporal LIPCOF and LWE, (r = -0.47 and -0.46; p < 0.01). MUC16 and MUC5AC correlated with corneal staining (0.36 < r < 0.53; p < 0.04).

CONCLUSIONS: Symptomatic contact lens wearers exhibit significantly more LWE and LIPCOF, and decreased MUC5AC reactivity. LWE and LIPCOF are significantly correlated; this may reflect their common frictional origin. Increased friction might follow from insufficient mucins, or an altered composition of the resident mucins at the ocular surface. In this study, we show that decreased mucin production is associated with the severity of LWE and LIPCOF.

Abstract: Clinical tests for successful contact lens wear

Rather an interesting one on attempts to quantify what makes for comfortable contact lens wear.

Clinical tests for successful contact lens wear: relationship and predictive potential.
Optom Vis Sci. 2008 Oct;85(10):E924-9.
Pult H, Purslow C, Berry M, Murphy PJ.

PURPOSE: Although comfort is important for contact lens wearers, common clinical tests can fail to predict patients' symptoms. Lid wiper epitheliopathy (LWE) and lid parallel conjunctival folds (LIPCOF) are related to dry eye symptoms in lens wearers. This study investigates the predictive value of LWE and LIPCOF as objective measures of discomfort, and their relation to the ocular surface in soft contact lens wearers.

METHODS: Subjects were classified as symptomatic or asymptomatic, using the Contact Lens Dry Eye Questionnaire (CLDEQ). Pre-lens tear break-up time (PLBUT), limbal and bulbar hyperaemia, corneal staining, LWE and LIPCOF were assessed in the right eyes of 61 (23 M, 38 F; mean age 32.1 years; range = 18 to 55) experienced contact lens wearers. Differences between groups, and relationships between LWE, LIPCOF (nasal, temporal and sum) and objective signs were examined using non-parametric analyses. The positive and negative predictive values for symptoms of each objective measure were calculated.

RESULTS: Thirty eight subjects were classified as asymptomatic, 23 symptomatic. LWE and LIPCOF severity scores were significantly increased in symptomatic patients (U-test, p < 0.03), while no significant differences were found between groups for PLBUT, corneal staining or hyperaemia (0.29 < p < 0.88). Significant positive correlations were found between LWE and LIPCOF scores (temporal r = 0.67, p < 0.001; nasal r = 0.39, p < 0.001), and between LWE and hyperaemia (bulbar, r = 0.28, p < 0.001; limbal r = 0.36, p < 0.001). Age and gender were different in the two groups (p < 0.05). The predictive value of temporal LIPCOF was positive = 56.9%, negative = 77.1% with a cutoff value of > or =2 (PPV/NPV/cutoff value), of nasal LIPCOF 70.7%/75.0%/> or =1, of LIPCOF Sum 79.8%/86.5%/> or =2, and of LWE 53.1%/81.1%/> or =1.

CONCLUSIONS: Contact lens wearers with dryness symptoms exhibit significantly more LWE and LIPCOF, but not increased corneal staining, bulbar hyperaemia or decreased PLBUT. LWE and LIPCOF are significantly correlated: this may reflect their common frictional origin. LIPCOF Sum severity scores appear to be most predictive for symptoms.

Abstract: Auto-immune dry eye

Decreased expression of antioxidant enzymes in the conjunctival epithelium of dry eye (Sjögren's syndrome) and its possible contribution to the development of ocular surface oxidative injuries.
Histol Histopathol. 2008 Dec;23(12):1477-83.
Cejková J, Ardan T, Simonová Z, Cejka C, Malec J, Dotrelová D, Brunová B.

Previous studies have described elevated lipid peroxidase, myeloperoxidase and xanthine oxidoreductase/xanthine oxidase levels on the ocular surface of patients suffering from autoimmune dry eye (Sjögren's syndrome, SS). Reactive oxygen species generated by various enzymatic systems may be dangerous to the eye if they are not sufficiently cleaved by antioxidants. Because antioxidants have not been investigated in dry eye, the aim of this study was to examine the expression of antioxidant enzymes that cleave reactive oxygen species and play a key role in antioxidant protection. Conjunctival epithelial cells of dry eye (SS) patients were obtained by the method of impression cytology using Millicell membranes. Normal eyes served as controls. In the conjunctival epithelium superoxide dismutase, catalase and glutathione peroxidase were examined immunohistochemically. The enzyme expression levels were determined by image analysis and statistical evaluation. In contrast to normal eyes, where antioxidant enzymes were highly expressed in the conjunctival epithelium, in dry eye their expression was much less pronounced in correlation with the increasing severity of dry eye symptoms. Our study suggests that the decreased expression of antioxidant enzymes in dry eye disease (SS) contributes to the development of anterior eye surface oxidative injuries.

Abstract: The Aging Lacrimal Gland

The Aging Lacrimal Gland: Changes in Structure and Function.
Ocul Surf. 2008 Oct;6(4):162-174.
Rocha EM, Alves M, Rios JD, Dartt DA.

ABSTRACT The afferent nerves of the cornea and conjunctiva, efferent nerves of the lacrimal gland, and the lacrimal gland are a functional unit that works cooperatively to produce the aqueous component of tears. A decrease in the lacrimal gland secretory function can lead to dry eye disease. Because aging is a risk factor for dry eye disease, study of the changes in the function of the lacrimal gland functional unit with age is important for developing treatments to prevent dry eye disease. No one mechanism is known to induce the changes that occur with aging, although multiple different mechanisms have been associated with aging. These fall into two theoretical categories: programmed theories of aging (immunological, genetic, apoptotic, and neuroendocrine) and error theories of aging (protein alteration, somatic mutation, etc). Lacrimal glands undergo structural and functional alteration with increasing age. In mouse models of aging, it has been shown that neural stimulation of protein secretion is an early target of aging, accompanied by an increase in mast cells and lipofuscin accumulation. Hyperglycemia and increased lymphocytic infiltration can contribute to this loss of function at older ages. These findings suggest that an increase in oxidative stress may play a role in the loss of lacrimal gland function with age. For the afferent and efferent neural components of the lacrimal gland functional unit, immune or inflammatory mediated decrease in nerve function could contribute to loss of lacrimal gland secretion with age. More research in this area is critically needed.

Abstract: Epithelial-immune cell interaction in dry eye

Should be an interesting read for the docs that can access the full article....

Epithelial-immune cell interaction in dry eye.
Cornea. 2008 Sep;27 Suppl 1:S9-11.
Pflugfelder SC, de Paiva CS, Li DQ, Stern ME.

Dry eye is a potent stimulus of both innate and adaptive immune systems. At the nexus of the dry eye inflammatory/immune response is the dynamic interplay between the ocular surface epithelia and the bone marrow-derived immune cells. On the one hand, ocular surface epithelial cells play a key initiating role in this inflammatory reaction. On the other hand, they are targets of cytokines produced by activated T cells that are recruited to the ocular surface in response to dry eye. This interaction between epithelial and immune cells in dry eye will be thoroughly reviewed.

Abstract: LASIK and the ocular surface

Nice succinct summary of the major ocular surface complications LASIK can present. Note in particular the reference to RCE happening to people who already had a poorly adhering epithelium. This is one of the reasons that if you're going to get laser surgery, you need to be evaluated really, really thoroughly by a specialist first... Mild ABMD is not obvious, and I know plenty of people who did not have it diagnosed before LASIK... and in a few cases, the first thing that caused them to learn about it was when their epithelium sloughed off after surgery. (By the way, that hurts. A lot.)

LASIK and the ocular surface.
Cornea. 2008 Sep;27 Suppl 1:S70-6.
Toda I.

Wound healing after LASIK sometimes compromises homeostasis of the ocular surface. Diffuse lamellar keratitis is a post-LASIK inflammatory condition in the interface that appears during the first week after LASIK. The etiology of diffuse lamellar keratitis is unknown, but the association with allergic reaction to detergent, bacteria, and other chemicals is suspected. The condition is mostly self-limiting. Topical and/or oral corticosteroids may be effective against stage 2 disease, whereas flap lift and irrigation might be required in stage 3. Epithelial ingrowth occurs in about 1% of LASIK eyes. Although most cases heal spontaneously, some require surgical removal. There are 2 known mechanisms for epithelial ingrowth: epithelial invasion and epithelial implantation. Epithelial invasion grows in 2 distinct ways--outside invasion and flap epithelial invasion. The latter type is often seen after enhancement and may be treatment resistant. Patients with compromised attachment of corneal epithelium before LASIK may develop recurrent corneal erosion, which sometimes requires phototherapeutic keratectomy. Subepithelial opacity after viral infection, even long after infection, often recurs after LASIK and affects refraction and visual acuity. Topical corticosteroid may be effective to prevent recurrence. Dry eye is a common complication after LASIK. Although post-LASIK dry eye is usually temporary, some patients complain of severe symptoms that may negatively influence their satisfaction with the outcome. For example, functional visual acuity significantly decreases after LASIK. The possible mechanisms for post-LASIK dry eye may be associated with loss of neurotrophic effect, damage of goblet cells, and altered corneal shape.

Some of you whose lives have been turned upside down for a couple of years by severe post LASIK dry eye might get a giggle out of this understatement from the abstract:

Although post-LASIK dry eye is usually temporary, some patients complain of severe symptoms that may negatively influence their satisfaction with the outcome.

For the laypeople reading this, don't forget "usually" can mean anywhere between 51% on up (and doctors, before you're tempted to tell me I'm overdramatizing things, go back and read the published studies that showed between 15 and 36% of patients having unresolved dry eye 6 months after surgery).

And any doctor that is surprised 24/7 pain can make you dissatisfied with an elective surgery, please raise your hand (grin).


On Saturday, March 7, 2009 the Sjogrens Syndrome Foundation will be hosting a one-day dry eye conference at the Marriott in Long Beach, California. There will be several doctors speaking, including SSF board chairman Gary Foulks MD, and there will be several companies exhibiting.

All dry eye topics will be covered (not just Sjogrens) and all dry eye patients are welcome to attend!

We don't have anything settled yet but... we'll definitely be having some kind of DryEyeZone social get-together that weekend, Friday or Saturday evening (or both).

More details will be posted here and on DryEyeTalk after the program is finalized. I'll also have brochures available.

Abstract: Signs vs. symptoms in Sjogrens patients

Hmph. I thought I had already reported on this but can't find it on the blog so I guess I didn't.

Basically just tells us... as we know... that the correlation between dry eye signs and symptoms is poor even for Sjogrens Syndrome patients, and suggests that reduced corneal sensitivity is part of the explanation.

[Correlation between signals and symptoms of dry eye in Sjögren's syndrome patients]
Arq Bras Oftalmol. 2008 Jul-Aug;71(4):547-52.
[Article in Portuguese]

Barboza MN, Barboza GN, de Melo GM, Sato E, Dantas MC, Dantas PE, Felberg S.

PURPOSE: To study the correlation between the signals and symptoms of dry eye in Sjögren's syndrome patients.

METHODS: We formed the case group with 17 Sjögren's syndrome patients and the control group with 25 normal patients. For evaluation of the symptoms the "Ocular Surface Disease Index (OSDI)" questionnaire was applied to both groups and, after that, all the individuals were submitted to the ocular tests: Schirmer I and II, coloration of the ocular surface with rose bengal, pachymetry and esthesiometry. Spearman's correlation test was used to analyze the correlations between signals and symptoms and Student's t test for independent samples was used for comparison of the averages of the values found by the "Ocular Surface Disease Index (OSDI)" questionnaire and the ocular tests between the patients of the groups.

RESULTS: This study had evidenced a weak correlation between "Ocular Surface Disease Index (OSDI)" symptoms and ocular tests, which it indicates that not all the patients who presented exuberant symptoms, showed proportionally modified tests. The cornea sensitivity of the case group was reduced when compared with that of the control group. All the studied parameters in the case group presented significant differences (p<0.05) when compared with the control group.

CONCLUSION: There was a weak correlation between Sjögren's syndrome patients' ocular symptoms and signals that indicate the severity of the illness. The variation of cornea sensitivity found in the Sjögren's syndrome patient group may be one of the responsible factors for this weak correlation. All the studied parameters were significantly modified in the Sjögren's syndrome patients group when compared with those found in the control group.

Abstract: Autologous serum (again)

While talking recently with a lady with severe post PRK dry eye who had recently sought (yet) another opinion from a well reputed corneal specialist, I was rather disgusted to hear that the doctor stated flatly that she does not ever use autologous serum because "it doesn't work". Hm. News to me. There has been a plethora of studies about it in the last couple of years - clearly it's helping at least enough people to fill a lot of studies and it does not deserve the big brush-off from ophthalmologists, especially if they have been unable to resolve their patients' symptoms in other ways.

Incidentally, the same doctor professed not to believe that PRK can cause dry eye or that LASIK can cause persistent dry eye. What is wrong with these people? Have they drunk too much pharmaceutical kool-aid, or don't they read their own peers' published studies at least once in awhile?

Autologous serum eye drops for the treatment of dry eye diseases.
Cornea. 2008 Sep;27 Suppl 1:S25-30.

Kojima T, Higuchi A, Goto E, Matsumoto Y, Dogru M, Tsubota K.
Department of Ophthalmology, Social Insurance Chukyo Hospital, Nagoya, Japan.

Conventional treatment of dry eye mainly consists of the use of preservative-free artificial eye drops and punctal occlusion. None of the commercially available artificial tear preparations include essential tear components such as epidermal growth factor, hepatocyte growth factor, fibronectin, neurotrophic growth factor, and vitamin A-all of which have been shown to play important roles in the maintenance of a healthy ocular surface epithelial milieu. We reported previously that autologous serum (AS) eye drops contain these essential factors and that AS eye drops are beneficial in the treatment of ocular surface diseases such as persistent epithelial defects, superior limbic keratoconjunctivitis, keratoconjunctivitis sicca, and neurotrophic keratopathy. However, there is some controversy regarding the efficacy of AS treatment. We demonstrated that this modality is more effective than artificial tears in a randomized control study. In in vivo and in vitro experiments, AS eye drops showed marked suppression of apoptosis in the conjunctival and corneal epithelium. Albumin, the major protein in serum, improved ocular surface damage in vivo and rescued apoptosis after serum deprivation in vitro. The biological background of AS eye drops and previous clinical studies of these medications for the treatment of dry eye are discussed.