Thursday, December 20, 2007

Study: Mizoribine in Sjogrens treatment

Just a passing mention and no details as to methodology or degree of improvement in the abstract, but since this does mention dry eye improvement, Sjogrens patients may want to check it out.

Efficacy and safety of mizoribine for the treatment of Sjögren's syndrome: a multicenter open-label clinical trial.

Nakayamada S, Saito K, Umehara H, Ogawa N, Sumida T, Ito S, Minota S, Nara H, Kondo H, Okada J, Mimori T, Yoshifuji H, Sano H, Hashimoto N, Sugai S, Tanaka Y.
Mod Rheumatol. 2007;17(6):464-9. Epub 2007 Dec 20

This multicenter clinical trial was performed to evaluate the efficacy and safety of mizoribine for the treatment of Sjögren's syndrome. Fifty-nine patients with a definite diagnosis of Sjögren's syndrome received 150;Smg of mizoribine daily for 16 weeks. The salivary secretion volume was determined at baseline, at weeks 8 and 16 after the start of the study treatment by the Saxon test, and clinical manifestations were assessed by the investigator and the patients using a 10-cm visual analog scale (VAS). Adverse drug reactions were reported in 18 patients, of whom 6 patients had to discontinue the study due to such adverse reactions; however, no serious adverse drug reactions definitely related to the study drug were noted. The salivary secretion volume, the rate of change in salivary secretion, the patients' own assessments of dry mouth and dry eyes, the investigators' assessment of oral sicca symptoms, and the investigators' overall assessment improved following the treatment regimen with statistical significance at week 16 after the start of treatment in comparison to the baseline values. These results suggested that mizoribine may be effective in producing a subjective and objective amelioration of the glandular symptoms in patients with Sjögren's syndrome, without observing any serious adverse effects related to this drug.

Study: More on the eyelid wipers

I don't have any particular comments, but I've always been interested in following what they're writing & studying about lid movement because of implications for dry eye.

Elastohydrodynamics of the Eyelid Wiper.
Jones MB, Fulford GR, Please CP, McElwain DL, Collins MJ.
Bull Math Biol. 2007 Dec 8

This paper presents an elastohydrodynamic model of the human eyelid wiper. Standard lubrication theory is applied to the fluid layer between the eyelid wiper and ocular surface. The role of the lubrication film is to reduce the shear stresses by preventing solid to solid contact between the eyelid wiper and ocular surface. For the lubrication film to be effective, it is required that the orientation of the eyelid wiper changes between the opening and closing phases of a blink. In order to model this, the hydrodynamic model is coupled with an elastic mattress model for the soft tissue of the eyelid wiper and ocular surface. This leads to a one-dimensional non-linear partial differential equation governing the fluid pressure in the lubrication film. In order to solve the differential equation, a loading condition or constraint equation must be specified. The resulting system is then solved numerically. The model allows predictions of the tear film flux from under the upper eyelid, as well as normal and shear stresses acting on the ocular surface. These factors are important in relation to dry eye syndrome, deformation of the cornea and contact lens design. It is found that the pressure and shear stress under the eyelid act across a length of approximately 0.1 mm which is consistent with clinical observations. It order to achieve a flow of tears from under the upper eyelid during a blink, the model requires that the normal force the eyelid applies to the ocular surface during the closing phase of the blink is significantly higher than during the opening phase of the blink.

Study: Botox blah blah dry eye blah blah mice

Sigh, these molecular-level things... I need a translator. The only thing that kind of jumped off the page at me from this one was that some of the inflammatory stuff was equally impervious to cyclosporine, corticosteroids and artificial tears.

Lacrimal gland inflammatory cytokine gene expression in the botulinum toxin B-induced murine dry eye model.
Park CY, Zhuang W, Lekhanont K, Zhang C, Cano M, Lee WS, Gehlbach PL, Chuck RS.
Mol Vis. 2007 Nov 29;13:2222-32.

PURPOSE: To determine the effect of keratoconjunctivitis sicca, induced by botulinum toxin-B (BTX-B), on the inflammatory cytokine gene expression in the lacrimal gland (LG). And to determine the effect of various topical anti-inflammatory agents on the resulting cytokine levels.

METHODS: Forty-two mice (eight-week-old, female, CBA/J) were divided into six groups. Four groups were injected with BTX-B into both lacrimal glands, one group was injected with saline into both LG (Sal, n=7), and one group served as an uninjected control (Con, n=7). The four groups of BTX-B injected mice were then assigned to a treatment group: 1. no additional treatment (BTX), 2. artificial tear treatment (AT), 3. Cyclosporine A (CSA) treatment, and 4. fluorometholone (FM) treatment (n=7 in each group). Corneal fluorescein staining was evaluated one, two, and four weeks after injection. LGs were harvested after two weeks (groups Con, Sal, and BTX) and four weeks (groups AT, CSA, and FM) after injection. Gene microarray analysis for inflammatory cytokines and their receptors, real time reverse-transcriptase polymerase chain reaction (RT-PCR), and immunofluorescent staining with anti-mouse CD3e monoclonal antibody were then performed on LG tissue.

RESULTS: BTX-B injection into the LG effectively induced dry eye in mice two and four weeks following injection. Microarray data identified the proinflammatory cytokines interleukin (IL)-1, tumor necrosis factor (TNF)-alpha, IL-12, and macrophage migration inhibitory factor (MIF) and the anti-inflammatory cytokines IL-10 and toll-interacting protein (Tollip) as candidates for validation by real time RT-PCR. MIF and IL-12 expression were elevated in BTX-B injected mice at weeks 2 and 4 regardless of treatment. Tollip and IL-1 expressions were increased in some groups after BTX-B injection regardless of the treatment type. Other cytokines showed no significant changes. LG structures were well maintained without significant T lymphocyte infiltration in all groups.

CONCLUSIONS: Ocular surface change induced by BTX-B injection resulted in an altered expression of various inflammatory cytokines in our murine dry eye model. Alteration of the pathology-induced cytokine profile by topical therapy is reported.

Newsblurb: The office environment & dry eye

Five reasons your office is bad for you

1. Sights for Sore Eyes. According to a study reported in the Survey of Ophthalmology, computer users risk tired, red eyes, burning and blurred or double vision. People blink up to 60 percent less often while looking at the screen, causing dry-eye symptoms. The cornea is also sensitive to office hazards like dry air, airborne paper dust and ventilation fans. To protect yourself, look away from the screen and at a distant object at least every 30 minutes. Use eye drops if you feel strain. And if you wear reading glasses and work at a computer more than an hour a day, researchers recommend a pair of glasses especially designed for the distance you normally sit from the screen.

Newsblurb: Lissamine green

Alright, I've been seeing this creep into the news here and there for the last several weeks so I figured I'd better eventually post about it.

Detecting Dry Eye

...DETECTION: Lissamine green is an eye-drop stain used by ophthalmologists to detect damaged cells on the eye's surface. They turn green under special lighting, helping doctors identify potentially dangerous conditions. Researchers from UT Southwestern Medical Center in Dallas, Texas were able to identify three basic patterns produced by the stain that indicate progressively dangerous conditions. The least severe pattern, known as nasal staining, is indicated by stains limited to the whites of the eyes between the lids toward the nose. The second level appears as stains in the white of the eye between the lids, but toward the ear. This pattern is diagnostic of tear deficiency. The third and most severe level occurs when the stain appears on the cornea.

New drug news: NOVA22007

Per a news item from Novagali Pharma on Tuesday, this is expected to enter Phase III clinical trials in the US in the second quarter of 2008.

In our clinical trial roster on The Dry Eye Zone I previously had this down as already being in Phase III (based on an April press release) but I've relegated it to Phase II till the Phase IIIs actually start.

Thursday, December 13, 2007

New drug news: p.s.

I posted the other day about Alcon's Vexol being in clinical trials with a 2009 NDA expected.

I've been asked why, since this is an already FDA approved corticosteroid which has been on the market for quite some time. The reason for the new clinical trials and new FDA submission is to broaden its indications to specifically include dry eye. As you know topical steroids have been used in dry eye treatment for quite awhile (and Lotemax has been particularly prominent of late) - however, dry eye is an off-label use of topical steroids. Getting FDA approval for a steroid drop specifically for dry eye would mean that the company can market it directly to consumers ala Restasis.

Wednesday, December 12, 2007

Study: Ocular surgery and dry eye

Minor abstract from a European journal. Nothing earthshattering. The reason I'm posting it is that I find myself increasingly bewildered as to WHY eye surgery patients are not told that they may - and in many cases probably will - experience dry eye either in the short or long term, so that they can be prepared and can learn how to address it before it bushwhacks them with (in some cases) intense pain.

I had a call the other day from a 33-year-old woman who had corneal transplants (advanced keratoconus case) in her 20s. No one ever told her, before OR after her surgeries, how it might affect her tear production; seems I was the first person she had heard say that her current condition did not surprise me given her history. Many of my women readers will be grimacing in sympathy for her increased dry eye susceptibility when they hear she has several young children. For heaven's sake, even LASIK is well known to cause dry eye in a substantial percentage of patients with or without other risk factors - let alone when you cut out a complete corneal button and replace it.

Please doctors, tell patients about dry eye before medically necessary eye surgeries.

The influence of ocular surgery for lacrimal secretion
Samoilă O, Stan C, Vişan O, Crăciun A, Dican L, Mera M
Oftalmologia. 2007;51(3):81-5
Article in Romanian

Dry eye syndrome remains a constant health problem while more and more patients are being involved and final data concerning the etiopathogeny is still missing. This study investigates the hypothesis that ocular surgery inflicts damage on the tear production (regarding quantity, quality or the compositional aspect). Ocular symptomathology was registered with the help of a questionnaire. Lacrimal tests were applied before and after surgery at 6 weeks. Basic and reflex tear secretion was differentiated through Schirmer tests and tear quality was assessed with BUT. Proteomic analysis (global proteins, electrophoresis) and conjunctival biopsy was realized before surgery. Open eye surgery altered tear secretion in 91% of the 22 patients examined.

Tuesday, December 11, 2007

New drug news: Steroids & stuff

Alcon has Vexol (a corticosteroid) listed on their pipeline as a probably FDA submission for 2009 and it appears in at least one clinical trial database as being in Phase II. I assume this is their answer to the current trend of attacking inflammation (or at least B&L's aggressive Lotemax campaigns).

I haven't heard a PEEP about Rebamipide in ages. Hey Novartis, what gives?

I'm now showing a total of 7 dry eye drugs in Phase III, another 7 in Phase II, and 9 in earlier development. Presumably something somewhere in all this melee is going to turn out really useful.

Sunday, December 9, 2007

New drug news: Dehydrex

This is one of those little-known things that manages to fly under the radar. I never would have known about it except that I was digging around for hyperosmotic agents and came across a reference to Dehydrex in a 1985 abstract. I googled it and one thing led to another.

Dehydrex has been around for, oh, 25 years or so and has been considered an orphan drug, used for treatment of recurrent corneal erosions. Some years ago (2001, according to the FDA website) clinical trials were started with FDA support from their Orphan Products Development program. I understand the clinicals were very successful and were recently completed and that an NDA will be filed.

Assuming this gets approved - which based on the clinical trial structure and results seems like a safe assumption - I would not be surprised if it turned out to be useful for a wider indication than RCEs.

Those of you who have followed Dr. Holly's work may be interested to know that Dehydrex was a Dextran-based predecessor of Dwelle, which was Dr. Holly's later development continuing down the "high oncotic pressure" route. Hence its popularity - alas, anecdotally, since no study has ever been completed and published on this specifically, that I know of - in treatment of RCEs.

2008 forecast

I'm going to venture a prediction about the dry eye drug scene in the coming year.

I predict that in the US we will see a trend towards filing NDAs (new drug applications) with the FDA for eyedrops well off the beaten path of the new drug model where a small company comes up with something new and promising, gets some capital to put it through some testing, then gets bought by a pharma and proceeds through all the agony of Phase III clinical trials.

I think we'll see 2 to 5, possibly even more, NDAs of this less conventional type. The formulations will not be particularly sexy. They may be substances that are sold over-the-counter everywhere except the US due to the weird way the FDA regulates OTC eyedrops, or they may even be substances currently compliant (more or less) with the OTC regs that actually have considerable therapeutic potential and therefore deserve to be in a different category, though whether they merit the price consumers (or their insurers) will be feverishly (or reluctantly) doling out for them may remain a question. I also predict that one or more of these will be more effective than any other Rx dry eye drug, and that one or more of these will be nothing more than an artificial tear sold at an absurdly high price.

Study: Cooties on the cornea... What to do, what to do

Ocular Pathogen or Commensal: A PCR-Based Study of Surface Bacterial Flora in Normal and Dry Eyes.
Graham JE, Moore JE, Jiru X, Moore JE, Goodall EA, Dooley JS, Hayes VE, Dartt DA, Downes CS, Moore TC.
Invest Ophthalmol Vis Sci. 2007 Dec;48(12):5616-23

PURPOSE: To compare the bacterial population of the ocular surface of normal and dry eye subjects using conventional culture and 16S rDNA PCR.
METHODS: Ninety-one subjects were classified as normal (n = 57) or dry eye (n = 34) by using tear break-up time, McMonnies survey, goblet cell density, and meibomian gland assessment. Conventional bacterial culture and broad-range 16S rDNA PCR, cloning, and DNA sequencing were used for bacterial identification. Repeated sampling was performed in a subset of subjects over a 3-month period. The association between goblet cell loss and bacterial counts in a subgroup of subjects was assessed.
RESULTS: Most of the bacteria identified by culture were coagulase negative staphylococci, whereas molecular methods demonstrated a considerable number of additional bacteria. Atypical ocular surface bacteria including Rhodococcus erythropolis, Klebsiella oxytoca, and Erwinia sp., were identified in cases of overt inflammation and, surprisingly, on the normal ocular surface. The same bacteria remained on the ocular surface after repeated sampling. Increased bacterial flora was associated with reduced goblet cell density.
CONCLUSIONS: Molecular analysis revealed a diverse ocular surface bacterial population. In addition to the normal flora, various potentially pathogenic bacteria were identified. The detection of known pathogens in both normal and dry eyes, with minimal signs of infection, presents a diagnostic dilemma. It remains unknown whether their presence is associated with inflammation and reduced goblet cell density or whether they adversely affect the ocular surface predisposing it to abnormal microbial colonization. In the absence of overt clinical infection, it is unknown whether such results should prompt intervention with therapy.

Study: Another dry eye diagnostic

No comment. I'm permanently jaded and confused after reading about so many new and exciting dry eye diagnostics that I can't keep them straight. Somebody wake me up when one gets adopted for use in a major clinical trial.

Y'all know that one of my hangups is differentiation between aqueous tear deficiency, meibomian gland dysfunction and other ocular surface disease. So from my perspective, how dry your surface is at 2:38pm on December 10th, 2007 does not tell ME a whole heck of a lot except that, if it's awfully dry, it ought to add something to the urgency of finding out WHY in order to treat it appropriately.

On the other hand, a key use of a standardized, reliable dry eye diagnostic would be for what I really, really, really want to see: a really, really good epidemiological study of dry eye. So my first question about these diagnostics is, how long does it take, how much does it cost and how much training does it take to perform reliably?

Automatic dry eye detection.
Yedidya T, Hartley R, Guillon JP, Kanagasingam Y.
Med Image Comput Comput Assist Interv Int Conf Med Image Comput Comput Assist Interv. 2007;10(Pt 1):792-9.

Dry Eye Syndrome is a common disease in the western world, with effects from uncomfortable itchiness to permanent damage to the ocular surface. Nevertheless, there is still no objective test that provides reliable results. We have developed a new method for the automated detection of dry areas in videos taken after instilling fluorescein in the tear film. The method consists of a multi-step algorithm to first locate the iris in each image, then align the images and finally analyze the aligned sequence in order to find the regions of interest. Since the fluorescein spreads on the ocular surface of the eye the edges of the iris are fuzzy making the detection of the iris challenging. We use RANSAC to first detect the upper and lower eyelids and then the iris. Then we align the images by finding differences in intensities at different scales and using a least squares optimization method (Levenberg-Marquardt), to overcome the movement of the iris and the camera. The method has been tested on videos taken from different patients. It is demonstrated to find the dry areas accurately and to provide a measure of the extent of the disease.

Study: Childhood diabetes and dry eye

Not too much to comment on here. Basically... the non-news that kids with Type 1 diabetes are more likely to have dry eyes than kids without.

Dry eye syndrome in diabetic children.
Akinci A, Cetinkaya E, Aycan Z.
Eur J Ophthalmol. 2007 Nov-Dec;17(6):873-8.

PURPOSE. To compare the symptoms, signs, and results of objective tests for dry eye syndrome (DES) in type 1 diabetes mellitus (T1DM) patients and controls.
METHODS. A total of 104 children with T1DM and 104 age- and sex-matched controls were compared in terms of the symptoms, signs, and results of objective tests for DES. Duration of T1DM, presence of diabetic retinopathy, mean hemoglobin A1c level, pubertal status, and a history of accompanying autoimmune disease were noted in T1DM group. Analysis of variance, multivariate regression analysis, Student t, Mann-Whitney U, and chi-square tests were used for statistical analysis.
RESULTS. A total of 15.4% of diabetic children complained of dry eye symptoms, versus 1.9% of the controls (p=0.029). Dry eye signs were detected in 7.7% of diabetic children, versus 0.96% of controls (p=0.034). Tear break-up time (TBUT) and Schirmer test results were significantly lower in T1DM group than controls (p=0.018, p=0.024, respectively). A total of 7.7% of diabetic children had definite and 0.96% had probable diagnosis of DES, versus none of the controls (p=0.03). TBUT and Schirmer test results were significantly lower in patients with more than 10 years duration of T1DM (p<0.001 for both).
CONCLUSIONS. The prevalence of symptoms, signs, and definite diagnosis of DES are higher and basal tear secretion and tear film stability are lower in diabetic children than controls. Duration of T1DM is the only disease-related variable which is associated with basal tear secretion and tear film stability.

Study: BSLPD to treat DES in cGVHD

Anybody know if there are any scientific journals dedicated to the blogosphere yet? If so, remind me to do a search and see whether there are any published studies examining the effect of overuse of acronyms in subject lines on click-through rates in blogs. (And then maybe the impact on reader drop-out rates when five or more prepositional phrases are used in a row in the opening sentence of a blog entry.)

Meanwhile, our good friends at the Boston Foundation for Sight have published another study. About use of sclerals in treating dry eye in chronic graft-versus-host-disease patients.

For those of you skeptics (I'm talking to MDs here, primarily) who stubbornly adhere to the antiquated notion that scleral lenses and dry eye do not belong in the same sentence, and who would perhaps rather condemn these patients to tarsorrhaphy, Lacrilube and chronic misery, this one's for you.

Boston Scleral Lens Prosthetic Device for Treatment of Severe Dry Eye in Chronic Graft-Versus-Host Disease.
Jacobs DS, Rosenthal P.
Cornea. 2007 Dec;26(10):1195-1199

PURPOSE:: To determine if the Boston Scleral Lens Prosthetic Device (BSLPD) reduces symptoms and improves quality of life in patients with severe dry eye from chronic graft-versus-host disease (cGvHD).

METHODS:: This is a noncomparative interventional case series reporting 33 consecutive patients with severe dry eye from cGvHD, unresponsive to conventional therapy, who were fitted with the BSLPD. A patient survey was undertaken after lenses were dispensed and worn regarding the effect of scleral lens wear on their symptoms, quality of life, and activities of daily living. The patient population was characterized from a retrospective chart review. Survey data were tabulated.

RESULTS:: BSLPD wear resulted in improvement in pain, photophobia, and general quality of life in nearly all patients, with more than half reporting the highest improvement level for pain (52%) and photophobia (63%), and more than two thirds (73%) reporting the highest improvement level for quality of life. There was improvement in reading and driving in >90% of those who reported previous compromise, with >60% reporting the highest improvement level for each of these activities.

CONCLUSIONS:: The BSLPD mitigates symptoms and improves quality of life in patients with severe dry eye from cGHvD.

Monday, November 26, 2007

To "Anonymous" who complained about the "grey on blue"

This blog is not grey on blue, it's dark grey on white. I saw what you were talking about briefly tonight - I think it's running really slow or something so at times it was not loading the proper color background.

By the way, it never hurts to be POLITE when you're complaining or making a suggestion.

Friday, November 23, 2007

Study: Gel-to-drop, for Rx or OTC

Hm. Is this basically a souped-up version of the Lacriserts concept, or more? Sounds interesting anyway.

It seems as though there are always some kind of technologies in the works to reduce or eliminate the need for eyedrop application. Several I've read about or been talked at about by excited inventors in the past year or so include a punctal plug that secretes drops, contact lenses used to deliver drugs, special glasses with a microchip and tiny jets aiming a stream of tiny drops at the eyes, and now this gel-to-drop drug delivery system. It will be interesting to see if any of these types of things ever really comes to fruition.

Sustained Ocular Drug Delivery from a Temperature and pH Triggered Novel In Situ Gel System.
Gupta H, Jain S, Mathur R, Mishra P, Mishra AK, Velpandian T.
Drug Deliv. 2007 Nov;14(8):507-15.

Various ocular diseases like glaucoma, conjunctivitis, and dry eye syndrome require frequent drug administration. Poor ocular bioavailability of drugs (< 1%) from conventional eye drops is due mainly to the precorneal loss factors that include rapid tear turnover, nonproductive absorption, transient residence time in the cul-de-sac, and the relative impermeability of the drugs to corneal epithelial membrane. These problems may be overcome by the use of in situ gel-forming systems that are instilled as drops into the eye and undergo a sol-gel transition in the cul-de-sac. Our present work describes the formulation and evaluation of an ocular delivery system of timolol maleate based on the concept of both temperature and pH-triggered in situ gelation. Pluronic F-127 (a thermosensitive polymer) in combination with chitosan (pH-sensitive polymer also acts as permeation enhancer) was used as gelling agent. The developed formulation was characterized for various in vitro parameters e.g., clarity, gelation temperature and pH, isotonicity, sterility, rheological behavior, drug release profile, transcorneal permeation profile, and ocular irritation. Developed formulation was clear, isotonic solution, that converted into gel at temperatures above 35 degrees C and pH 6.9-7.0. A significant higher drug transport across corneal membrane and increased ocular retention time was observed using the developed formulation. The developed system is a viable alternative to conventional eye drops for the treatment of glaucoma and various other ocular diseases.

Study: Where da numbers?

Right on boys. The acid test: IS LIFE BETTER with this drug? Let's see some numbers please. It's not new anymore - it's been around long enough to figure this out.

Pharmacoeconomics of new medications for common chronic ophthalmic diseases
Hirsch JD, Morello C, Singh R, Robbins SL.
Surv Ophthalmol. 2007 Nov-Dec;52(6):618-33

There is increasing pressure for medical care reimbursement to be linked to outcomes. New medications approved for glaucoma, age-related macular degeneration (AMD), and dry eye disease may offer improved outcomes, but they have higher acquisition costs. This article reviews published pharmacoeconomic studies assessing the incremental change in outcomes achieved vs. the increased medication costs incurred....Notably missing in all analyses are the effects of improved treatment on patient productivity. Although the diversity and small number of studies limit conclusions, there is some evidence that the newer glaucoma medications, as a group, produce economic offsets such as reduced glaucoma surgeries and fewer physician visits. Photodynamic therapy for AMD may be cost-effective when used early in patients with better visual acuity allowing cost-offsets over longer periods of time to be considered. The single pharmacoeconomic analysis of topical cyclosporine for dry eye disease was only hypothesis-generating. Comprehensive studies that investigate clinical, economic, and humanistic outcomes for the patient and society are needed to adequately assess the comparative value of current and future ophthalmic medications.

Study: "Osmoprotection"

Sorry but... my tolerance for hyperosmotalk wore out somewhere in the years of "complete dry eye relief for everyone" marketing which so far as I can tell has not yet completely relieved everyone.

Osmoprotection as a new therapeutic principle
Messmer EM, Ophthalmologe. 2007 Nov;104(11):987-990.

Dry eye syndrome is one of the most common disorders encountered in daily ophthalmological practice. New pathophysiological concepts have been developed over the last few years. Hyperosmolarity of the tear film is one of the key pathogenetic factors in the development of a - commonly subclinical - inflammation of the ocular surface, the lacrimal gland and the tear film in dry eye syndrome. Osmoprotective agents act through compatible solutes to prevent - at least in theory -a hyperosmolar tear film from damaging the ocular surface.

Monday, November 19, 2007

Another update on my BSLs (one more entry on a very long list for Thanksgiving this year....)

Well, last Monday I think I pretty much gave my BSLs the acid test, and they passed with flying colors.

First, I stayed up past midnight on Sunday. Had to take out my lenses around 10pm, so my eyes had two whole hours during which to dry out nicely before bed.

Next, I got up at quarter to three, showered, finished packing, and drove 1.5 hours through a wet windstorm to make an early flight. Managed to time the drive just right... on Monday mornings, if you don't make it to SeaTac at just the right time, you're screwed. I'm glad I took the time to print out my boarding pass, and wasn't checking luggage. Even so, within 5 minutes of my joining the 100+ line at security, it had doubled - at least.

Next, 2.5 hour flight to Orange County. Took out my lenses so I could doze.

Later, a 1-hour drive up towards UCLA in an air conditioned rental.

After dinner (i.e. long after sunset), a hasty drive to LAX.

Next, hanging out in another lovely dry fluorescent-lit airport waiting for a delayed inbound aircraft. Then, another 2.5-hour flight, arrival late at night, and last, I drove myself home in the middle of the night, arriving about 24 hours after I'd gotten up.

NOW, all that sounds just like business as usual to any normal business traveler. By my own travel standards of years ago, that's a light day. But for the past 6 years - in wintertime, at least - THIS IS A BIG DEAL for me. I could not have driven myself to the airport at 4 in the morning with or without rain and wind and debris, I could not have driven down a 10 lane LA freeway (that's an awful lot of starburst-and-halo-generating headlights and taillights) freeway after dark, and I most certainly could not have driven myself home in the middle of the night under any circumstances, let alone after spending an entire day in some kind of rigid contact lens.

With my current pair of T6 BSLs, I can do all that. It's amazing, and I am so grateful. Thank you Dr. Rosenthal, and Mark. :-)

Travel tip for road warriors:

I discovered on this trip that Ocusoft lidscrub foam 50mLs are exempt from the liquids restrictions BUT they trigger a search and an interesting conversation with the security folks, so, um, next time if I'm not checking luggage I'll leave them at home....

Newsblurb: Dry as a desert

Nothing special about the news item per se but there's kind of a cute photo of some fake eyeballs in the sand. (Wee bit of time on our hands today, have we???)

Ozarks Health
Dry As A Desert

The women's health group released a report this summer naming office jobs, many requiring prolonged computer use, as the work most likely to contribute to dry eye. Next are construction and manufacturing jobs, which expose workers to dust, allergens and wind.

Contact-lens users are especially vulnerable to dry eye, Esposito says, because the lenses draw moisture off the eyes.

The condition is more common in Hispanic and Asian women and in people with autoimmune diseases such as Sjogren's syndrome, lupus and rheumatoid arthritis. People who take antihistamines, diuretics, antidepressants and other medications are at higher risk, too.

Study: Meibum lipids, tear lipids...

...Something tells me this study is interesting, I just don't know why... If anyone wants to enlighten me, feel free!

Temperature-induced conformational changes in human tearlipids hydrocarbon chains.
Biopolymers. 2007 Oct 5-15;87(2-3):124-33.Click here to read Links
Borchman D, Foulks GN, Yappert MC, Ho DV.

As a first step to characterize human meibum and tear lipids, infrared spectroscopy was applied to characterize the molecular structure/conformation and packing of hydrocarbon chains. Temperature-induced phase transitions were fit to a sigmoid equation and were experimentally reproducible and were similar for multiple samples collected from the same person. No hysteresis was observed. Hydration of polar tear lipids increased their phase transition cooperativity, enthalpy and entropy. Hydrophobic interactions in meibum lipid (ML) were stronger than in tear-fluid lipids (TL), as reflected by the higher entropy and enthalpy of the gel to liquid crystalline phase transition of ML. The results of this study provide further evidence of the differences in the composition and structure of ML and TL. The conformational changes observed in the hydrocarbon chains of ML with temperature suggest that the observed therapeutic increased delivery of ML with eye lid heating could be related to the increased disorder in the packing of the hydrocarbon tails. This work also highlights the power of infrared spectroscopy to characterize molecular structure/conformation, and packing of human tear lipids and provides a basis for future studies of tear film lipid composition-structure-function relationships and lipid-protein interactions in relation to age, sex, and dry eye symptoms.

Study: HCV and dry eye

Hmph. Dunno what I'm supposed to conclude here. (Don't let anybody cry on your shoulder?)

Hepatitis C and ocular surface disease.

Jacobi C, Wenkel H, Jacobi A, Korn K, Cursiefen C, Kruse FE.
Am J Ophthalmol. 2007 Nov;144(5):705-711. Epub 2007 Sep 17.Click here to read

PURPOSE: To assess the frequency of changes in the ocular surface and the presence of hepatitis C virus (HCV) in tear samples of patients with chronic HCV infection. DESIGN: Prospective, nonrandomized, clinical, interdisciplinary, single-center study. METHODS: Seventy-one patients with previously untreated chronic HCV infection and a control group consisting of 66 patients without systemic HCV infection were enrolled in the trial. The patients with HCV infection were screened for ocular symptoms, visual acuity, and ocular changes. Tear production was measured by the Jones test. Conjunctival impression cytologic analysis was performed. The presence of HCV ribonucleic acid (RNA) in tear and blood samples was determined by quantitative polymerase chain reaction. RESULTS: On examination, systemic HCV infection was present for a median of 30 months. Fifty percent of all HCV patients showed a decrease in tear production measured by the Jones test. Apart from epithelial changes related to dry eye syndrome in 12 patients, two patients presented mild peripheral corneal thinning. Polymerase chain reaction analysis detected HCV RNA in five (10%) of 52 tear samples. HCV RNA levels in tear samples (mean, 1.0 x 10(4) copies/ml) were considerably lower than in blood samples (mean, 5.3 x 10(5) copies/ml). CONCLUSIONS: Dry eye syndrome is the most frequently observed ocular feature in HCV infection. Patients with HCV infection (age range, 21 to 60 years) compared with the controls had a significant lower tear production (P = .05). The presence of HCV RNA in 10% of tear samples emphasizes the potential risk of viral transmission through tears.

Study: Kids, dry eye, systemic disease

Nothing too surprising or remarkable here. Focus is presumably on severe aqueous deficient dry eye which indeed is rare in kids and parents need to be proactive about searching out possible implications and tie-ins with systemic disease. I am disappointed that no mention was made of sclerals in these cases - I think that when you've got developing eyes and dryness severe enough to cause ulcers and loss of BCVA that ought to be a very attractive treatment route to consider.

Management of dry eye related to systemic diseases in childhood and longterm follow-up.

Mac Cord Medina F, Silvestre de Castro R, Leite SC, Rocha EM, de Melo Rocha G.
Acta Ophthalmol Scand. 2007 Nov;85(7):739-44. Epub 2007 Jun 8.

Purpose: Dry eye in children is not common in general practice and is usually referred to tertiary centres for diagnostic confirmation. In the present review we examine the potential causes of dry eye in children and report the management and longterm follow-up of dry eye in childhood with reference to clinical diversity, systemic associations, ocular outcomes and treatment trends. Methods: A retrospective, consecutive case series was studied by evaluating the clinical charts of children with dry eye over a 96-month period. Minimal diagnostic inclusion criteria were presence of ocular surface damage and tear deficiency. Results: Fourteen patients with an age range at presentation of 1-17 years were evaluated. Ten patients were female, four were male and all had bilateral involvement. The most frequent symptoms were red eye, photophobia and low visual acuity (VA). Four patients had corneal ulcers. Two patients had best corrected visual acuity (BCVA) less than or equal to 20 200 at first examination. One of these plus another patient presented with BCVA less than or equal to 20 200 received autologous serum tears and five submitted to conjunctival flaps to preserve the integrity of the eye. Associated systemic conditions were found in all patients and were congenital in six of them. Conclusions: Early manifestations of dry eye in childhood are a potential indication of systemic disease. The ocular condition may be misdiagnosed and correct treatment delayed. Most diseases are bilateral and may jeopardize VA. Systemic investigation, close follow-up and preparing the family for longterm and multidisciplinary treatment are necessary to preserve ocular health and identify systemic associations.

...But while we're talking about kids, let's not forget the more frequent problem of good ol' meibomian gland dysfunction, which sure seems to be on the rise amongst youngsters. Parents, if you want to invest in your kids' eye health... feed them right, don't overdo the drugs, and if they're wearing contacts, make sure you VIGOROUSLY reinforce all doctor instructions about caring for them.

Study: Larch arabi-something and wound healing

Below is an interesting new study that popped up on Medline. Usually I don't get too excited about studies with words of ten syllables other than to take a mental note along the lines of "here's something that might lead to something that eventually ends up in the drug pipeline ten years hence" but this one caught my eye. Larch trees are a little off the beaten track even for dry eye treatment, where we come across everything from snake oil to iguana spit. Plus, anything that talks about "mucoadhesive" properties (i.e. helping lubricants stay on the eye longer) is something I want to know about.

If I knew anything about naturopathy or dietary supplements (I don't) I probably wouldn't have had to google this polysaccharide (I did). Here's a link to an article with more background that I found helpful.

Larch Arabinogalactan for Dry Eye Protection and Treatment of Corneal Lesions: Investigation in Rabbits.
Burgalassi S, Nicosia N, Monti D, Falcone G, Boldrini E, Chetoni P. J Ocul Pharmacol Ther. 2007 Nov 14.

Purpose: The aim of the present study was to investigate the corneal protective and healing properties of arabinogalactan (AG), a natural polysaccharide present in conifers of the genus Larix (Larch). AG was tested in comparison with other two polysaccharides possessing well-established properties in the treatment of dry eye: tamarind seed polysaccharide and hyaluronic acid. Methods: The AG formulation was subjected to the following investigations: rheologic measurements; evaluation of mucoadhesive properties by rheologic interaction with mucin; ferning test; and in vivo evaluation on rabbits, including treatment of an experimental dry eye; evaluation of the preocular retention; and evaluation of healing rate of experimental corneal wound. Results: AG dispersions showed a newtonian nonviscous behavior, eta = 1.6 mPa . s for 10% w/w solution; it possessed good mucoadhesive properties useful for retention on the eye surface. In fact, a prolonged time of residence in rabbit eyes was ascertained using fluorescein-labeled AG. Five percent (5.0%) w/w AG exerted a good protective effect against the appearance of corneal dry spots. It also reduced significantly the healing time of an experimental corneal lesion since 27 h after the first treatment. Conclusions: These findings suggest that AG may be a potential therapeutic product for dry eye protection and for the treatment of corneal wounds.

Friday, November 9, 2007

Research news: Regenerx / TB4

Not quite "new" news - Regenerx were granted a US patent back in September, but honestly this is the first time it's come onto my radar screen. Everybody and his uncle seems to be in dry eye drug research these days.

Here's a November 5 newsblurb about it.

Reversing LASIK dry eye... now that's a pretty ambitious claim. But, I wish them every success. Sigh.

Late last week, Regenerx Pharmaceuticals (RGN) was awarded a patent in China for its Thymosin beta 4 (TB4) investigational products for the indications of reversing or inhibiting eye degeneration associated with dry eye syndrome. This includes dry eye that is caused by surgical eye procedures such as LASIK and PRK.

TB4 is a synthetic copy of a naturally occurring molecule that is identical across all species. It is a key regulator of actin, which is responsible for cell movement (for example, into a wound). Researchers from the Department of Biology, Shangdong University and the Peking Union Medical College in Beijing are verifying the therapeutic importance of TB4. To move the compound toward commercialization, Regenerx is conducting clinical trials of TB4 for dermal, ophthalmic and internal indications, but none of the trials is being carried out in China. The U.S. granted a patent for TB4 in September.

New drug news: Alcon / Lantibio / HLA

I blogged about this last month as there was a tidbit in Alcon's investor call mentioning they had a deal with Lantibio to market the HLA drop in the US. I still don't see an actual press release on Alcon's, Lantibio's or TRB Chemedica's sites but since it's on PRNewswire, it's presumably not a secret.

If I'm not mistaken... this is the same VisMed product that has been sold OTC in Europe for awhile and it's headed for the US Rx market in... probably not too long. I would think it can't be too hard to get this approved.

Full news report on

CHAPEL HILL, N.C., and VALAIS, Switzerland, Nov. 5 /PRNewswire/ -- Lantibio, Inc. and TRB Chemedica announced today the signing of a licensing agreement with a subsidiary of Alcon, Inc. for the US development, marketing, and manufacture of a Dry Eye Syndrome product. The product consists of a TRB patented formulation containing sodium hyaluronate and is currently being studied in the US under an IND by a subsidiary of Lantibio. An ongoing multi-center Phase III pivotal study is being conducted under the FDA's Special Protocol Assessment program. Lantibio expects to file an NDA in 2008 for the product as a treatment for Dry Eye Syndrome.

Study: Cytotoxicity of castor oil

In a fit of Friday afternoon good humor, I will forbear to editorialize on the implications for the notorious Restasis tolerance problems. Y'all probably know what I would say anyway. :) But... no wonder so few people like Endura.

Benefits and Side Effects of Different Vegetable Oil Vectors on Apoptosis, Oxidative Stress, and P2X7 Cell Death Receptor Activation.

Said T, Invest Ophthalmol Vis Sci. 2007 Nov;48(11):5000-6.

PURPOSE: Ocular side effects in patients using eye drops may be due to intolerance to the vector used in eye drops. Castor oil is the commonly used lipophilic vector but has been shown to be cytotoxic. Effects on cells of four oils (olive, camelina, Aleurites moluccana, maize) were compared with those of castor oil in human conjunctival cells.

METHODS: Human conjunctival cells were incubated with the oils for 15 minutes. After a 24-hour recovery period, cells were tested for viability, proliferation, apoptosis (P2X7 cell death receptor and caspase 3 activation), intracellular redox potential, and reactive oxygen species production. Fatty acid incorporation in cell membranes was also analyzed. In vivo ocular irritation was assessed using the Draize test.

RESULTS: Compared to the four other oils, castor oil was shown to induce significant necrosis and P2X7 cell death receptor and caspase 3 activation and to enhance intracellular reactive oxygen species production. Aleurites moluccana and camelina oils were not cytotoxic and increased cell membrane omega-3 fatty acid content. None of the five tested oils showed any in vivo ocular irritation.

CONCLUSIONS: The results demonstrated that castor oil exerts cytotoxic effects on conjunctival cells. This cytotoxicity could explain the side effects observed in some patients using eye drops containing castor oil as a vehicle. The lack of cytotoxic effects observed with the four other oils, Aleurites, camelina, maize, and olive, suggest that they could be chosen to replace castor oil in ophthalmic formulations.

Study: Self-closing puncta in GVHD...

Well, those who have struggled for years with plug discomfort, dropout, and above all cost might wish their puncta would occlude themselves... though on balance I'm sure they would not want to switch places with any of the patients described in this study.

Spontaneous Lacrimal Punctal Occlusion Associated with Ocular Chronic Graft-versus-Host Disease.

Kamoi M, Curr Eye Res. 2007 Oct;32(10):837-42.

Purpose: To investigate the clinical features of spontaneous lacrimal punctal occlusion (SLPO) after allogeneic hematopoietic stem cell transplantation (HSCT).

Methods: One hundred nineteen recipients after HSCT who visited Keio University between 2001 and 2004 were examined. The condition of the lacrimal punctum, severity of dry eye, meibomian gland secretion, and presence of systemic chronic graft-versus-host disease (cGVHD) were determined with or without SLPO by retrospective chart review.

Results: Among the 119 recipients, SLPO was diagnosed in 8. All the patients with SLPO after HSCT had meibomian gland dysfunction (MGD), dry eye, and systemic cGVHD. The percentage of patients with dry eye, MGD, and systemic cGVHD were significantly higher in recipients with SLPO than non-SLPO recipients (p < 0.0013, p < 0.00015, p < 0.0008, respectively).

Conclusions: SLPO is a clinical presentation of ocular cGVHD and may be an indicator of the severity of dry eye and systemic cGVHD after HSCT.

Study: Dry eye after, yes, CATARACT surgery

I really appreciated this study and hope to see more on the subject. I get calls regularly from people who had a cat surgery anywhere from 3-12 months previously, who are experiencing dry eye for the first time, and who have been told flatly by their doctor that cataract surgery is unrelated to dry eye. According to this study... there is enough risk to warrant finding out more and above all to be sensitive to how much BAK is thrown at the cornea postoperatively including strong attention to patient instruction and compliance monitoring.

Investigation of dry eye disease and analysis of the pathogenic factors in patients after cataract surgery.

Li XM, Hu L, Hu J, Wang W. Cornea. 2007 Oct;26(9 Suppl 1):S16-20.

PURPOSE: To study dry eye and analyze pathogenic factors in patients after cataract surgery.

METHODS: A total of 37 patients (50 eyes) were studied by using a 25-item National Eye Institute Visual Function Questionnaire (NEI-VFQ25) and Ocular Surface Disease Index (OSDI) 3 days before and 1 week, 1 month, and 3 months after cataract surgery. Slit-lamp microscope examination, cornea and conjunctiva fluorescein staining, tear breakup time (BUT), Schirmer test I (STI), and impression cytology (IC) were carried out at the same time. Cytologic specimens for IC were obtained from the upper lid-covered region, explosive region, and lower lid-covered region of the globe conjunctiva. The average density of goblet cells on these 3 regions was measured, and the pathogenic factors of dry eye after cataract surgery were analyzed.

RESULTS: After cataract surgery, the incidence of dry eye increased dramatically; NEI-VFQ25 and OSDI indicated that most patients developed this symptom after surgery. The lacrimal river line became narrow, and BUT and STI decreased in patients after cataract surgery. IC suggested the presence of serious squamous metaplasia in the epithelial layer of the globe conjunctiva, especially the lower lid region.

CONCLUSIONS: Dry eye can develop or deteriorate after cataract surgery if not treated in time. Misuse of eyedrops is one of the major pathogenic factors that causes dry eye after cataract surgery. Eyedrops should be carefully administered before and after cataract surgery to avoid or reduce the occurrence of dry eye postoperatively.

Thursday, November 8, 2007

Study: Here's one for the Genteal Gel fans

Efficacy, tolerability and comfort of a 0.3% hypromellose gel ophthalmic lubricant in the treatment of patients with moderate to severe dry eye syndrome.

Tauber J. Curr Med Res Opin. 2007 Nov;23(11):2629-36.

OBJECTIVE: To evaluate efficacy, safety and comfort of a 0.3% hypromellose (HM) eye gel (GenTeal Lubricant Eye Gel), with a sodium perborate preservative system and carbomer gelling agent, in patients with dry eye....

CONCLUSIONS: In a small, open-label study, this 0.3% HM eye gel showed statistically significant effects in relieving ocular symptoms and provides a well-tolerated formula that effectively reduced symptoms and improved ocular comfort in patients with dry eye syndrome.

Study: Egg whites, milk, toothpaste... and MGs and dry eye

No, this is not about dietary factors in dry eye... just innovative descriptions for what comes out of the MGs and which type of abnormal crud was most closely associated with dry eye.

Hey, I'm happy when an ophthalmologist deigns to even press on those little MG orifices and watch, let alone come up names for what comes out.

Abnormal property of meibomian secretion and dry eye syndrome

Gao Y et al, Yan Ke Xue Bao. 2007 Jun;23(2):121-5.

PURPOSE: To study the relationship between meibomian secretion and dry eye.

METHODS: To observe 68 outpatients (136 eyes) consecutively. Routine check up included vision, anterior segment and fundus, scoring of tear break up time (BUT), Schirmer I test and rose bengal staining (rb). Recorded the property of meibomian secretion. Defined the dry eye as mild and severe.

RESULTS: Meibomian secretion was sorted as egg-white-like secretion (n=28), milk-yellowish secretion (n=26), granular secretion (n=30) and toothpaste-like secretion (n=52). The result declared that BUT and rb scoring stepped up consecutively in the above secretions, that was higher in toothpaste-like secretion than in other groups (all P < 0.01). Schirmer I scoring was below 1 in all groups, and there was no difference in the groups. Fifty-four eyes (40%) met the criteria of dry eye syndrome. The incidence of dry eye stepped up in groups as egg-white-like secretion (2/28) 7.1%, milk-yellowish secretion (4/26) 15%, granular secretion (8/30) 27% and toothpaste-like secretion (40/52) 77%. The incidence was higher in granular secretion than in egg-white-like secretion (P < 0.05), while the incidence was higher in toothpaste-like secretion than in any of other 3 groups (P < 0.01). There was no severe dry eye in egg-white-like secretion and milk-yellowish secretion, while dry eye was found in 2 out of 8 in granular secretion, and in 19 out of 40 in toothpaste-like secretion. Incidence of severe dry eye was found higher in toothpaste-like secretion than in non toothpaste-like secretion (P < 0.05).

CONCLUSION: Abnormal meibomian secretion affects the stability of ocular surface. The patients with toothpaste-like secretion are prone to dry eye and tend to have a worse dry eye than other secretion groups.

Study: (yawn) Another Restasis cocktail

Evaluation of an isotonic tear in combination with topical cyclosporine for the treatment of ocular surface disease.

Hardten DR et al, Current medical research and opinion, 2007 Sep;23(9):2083-91

PURPOSE: To determine whether a new category of artificial tear product, carboxymethylcellulose 0.5% with compatible solutes (CMC-solutes) (Optive, Allergan, Inc., Irvine, California) improves clinical outcomes when used adjunctively with topical cyclosporine 0.05% (Restasis, Allergan, Inc., Irvine, California) for the treatment of ocular surface disease. METHODS: Nineteen patients with ocular surface disease treated with cyclosporine 0.05% for at least 3 months and who had previously used other artificial tears adjunctively were enrolled. Patients discontinued their previous artificial tear and used CMC-solutes, concomitant with topical cyclosporine 0.05%. Corneal evaluation and tear production parameters were evaluated before and during combined CMC-solutes/cyclosporine treatment. Patients also completed a questionnaire before and during treatment with combined CMC-solutes/cyclosporine. Follow-up was at 1 and 3 months. RESULTS: Most objective measures of ocular surface health were unchanged, but an improvement in conjunctival lissamine green staining and tear break-up time was found. Conjunctival lissamine green staining scores improved from 3.4 +/- 2.5 to 1.9 +/- 2.5 by Month 3 (p = 0.004). Tear break-up time improved from 4.6 +/- 3.9 s pre-treatment to 5.3 +/- 3.8 s post-treatment (p = 0.049). Ocular Surface Disease Index (OSDI) scores improved from 16.2 +/- 9.4 at baseline to 11.5 +/- 8.9 at month 3 (p = 0.007). Subjectively, patients graded their ocular discomfort as 2.7 at baseline and as 2.3 at Month 3 (p = 0.049). At Month 3, 89.5% of patients said they liked CMC-solutes as well or better than previous drops they had used. All patients said CMC-solutes provided similar or improved relief of symptoms of dry eye than previous eye drops. There were no tear-related adverse events reported. CONCLUSIONS: In this study, CMC-solutes, when used in conjunction with cyclosporine 0.05%, provided patients with an improvement in objective signs and subjective symptoms of ocular surface disease compared to their previous artificial tears. Further studies are warranted.

My translation: (Forgive me, or put it down to PMS...)

PURPOSE: To keep as many patients on Restasis as possible by finding yet another drop which if taken with Restasis might make them feel better. Oh, and to sell yet another Allergan product.

METHODS: Hand 19 random Restasis users (hm, wonder how long they had been on Restasis and whether they were at the magic 3 month point - or is the the magic 7 month point - or is it the magic 12 month point now?) yet another artificial tear (hm, wonder what they used to use and which ones the discontinuation of which is most likely to lead to improved comfort?) to try. Most of those tears have a honeymoon period before they join the drawerful of rejects in the bathroom, so there's always a chance they might like it better for long enough to capture some useful data.

RESULTS: No need to translate this part, I'll just quote: "Most objective measures of ocular surface health were unchanged". Ah, but OSDI improved. Go figger.

CONCLUSIONS: Start prescribing Optive with Restasis to patients who aren't yet showing any benefit from Restasis until somebody publishes a study with better results than this.

Like I said, I'm a cynical old thing, especially of a Wednesday morning without caffeine. Down in the depths of my heart...somewhere... I do sincerely appreciate all the efforts to make Restasis more tolerable.

Study: The search for hormonal links goes on...

This one found no differences in testosterone levels amongst women with and without dry eye.

Total testosterone level in postmenopausal women with dry eye

Duarte MC et at, Arg Bras Oftalmol. 2007 May-Jun;70(3):465-9

PURPOSE: The purpose of this study was to compare total testosterone blood level among three groups of postmenopausal women: control, mild to moderate dry eye and severe dry eye.
METHODS: Twenty-nine postmenopausal women were selected. The exclusion criteria were: hormone replacement therapy in the last 8 weeks, mechanical palpebral abnormalities, pterygium, lacrimal obstructions, intraocular inflammation or contact lens use. A blood sample was collected for total testosterone level determination, and the patients were submitted to an ophthalmologic examination (emphasizing on dry eye detection) and answered the OSDI (Ocular Surface Disease Index) questionnaire. Five patients were excluded. Postmenopausal women were divided into three groups according to OSDI score and the ophthalmic examination.
RESULTS: Five patients were classified in the no dry eye group (control), fifteen in the mild to moderate dry eye group and four in the severe dry eye group. There were no statistically significant differences regarding mean age (p=0.3915); instruction level (p=0.9333); number of comorbidities (p=0.2551); medication taken (p=0.2844) and total testosterone level among those groups (p=0.1275).
CONCLUSION: Further research with a greater bigger sample is necessary to establish the relation of androgen levels in dry eye patients.

Study: Bleph underdiagnosed, undertreated

Well golly, I'd kinda noticed that - based on the number of people visiting Dry Eye Talk or calling who had never heard of it but from whose description of their symptoms almost certainly have it. Seems like sometimes it only gets diagnosed if the patient's got horribly crusty lid margins.

Chronic blepharitis. Pathogenesis, clinical features, and therapy

Auw-Haedrich C, Reinhard T, Ophthalmologe, 2007 Sep;104(9):817-26; quiz 827-8

Chronic blepharitis is one of the most common diseases of the eyelids, but surprisingly, it is not often recognized. Frequently, a skin disease such as seborrheic dermatitis, atopic dermatitis, or acne rosacea is the underlying cause of chronic blepharitis. Bacterial pathological lipase, cholesterylesterase production, and bacterial lipopolysaccharides are pathogenetically relevant. Only rarely do genuine bacterial infections play a role. Collarettes occur at the base of the eye lashes, and the Meibomian glands show either abundant fluid secretion or inspissated secretion with obstruction of the orifices. Chronic blepharitis can include sequelae including dry eye and corneal and lid contour changes. The basic treatment comprises attendance of the underlying dermatological disease and lid hygiene. In addition, preservative-free tear film substitutes, antibiotics, immunomodulatory agents, or even surgical intervention may become necessary.

Study: OCI an alternative to OSDI?

The "Ocular Comfort Index"

Measurement of ocular surface irritation on a linear interval scale with the ocular comfort index.
Johnson ME, Murphy PJ, IOVS, 2007 Oct;48(10):4451-8.Click here to read

PURPOSE: To examine the psychometric properties of the Ocular Comfort Index (OCI), a new instrument that measures ocular surface irritation designed with Rasch analysis to produce estimates on a linear interval scale.

....CONCLUSIONS: The OCI was shown to have favorable psychometric properties that make it suitable for assessing the impact of ocular surface disease on patient well-being and changes in severity brought about by disease progression or therapeutic strategies.

With more scientifically validated instruments emerging to measure how people with ocular surface disease feel... there is even less excuse for failing to employ them.

It's not hard. Your tech hands the patient a sheet of paper where they answer 12 simple questions. Slip it into their medical record. Repeat in six months. Not too painful now was it?

Some suggested times for doing it... And no, this is NOT a multiple-choice test.

1) Every time a dry eye patient comes in for a checkup.
2) Every 6 months for your glaucoma patients who are on BAK-preserved drops.
3) Every LASIK pre-operative exam.
4) The 1-, 3-, 6- and 12-month LASIK follow-up exams - and not just for the patients who are actually complaining about discomfort. If you don't measure them all, you won't know. I'm generously assuming you might like to.

Dry eye PATIENTS - you can self-administer these tests. For those of you who are compulsively trying new therapies, consider undergoing the discipline of actually finding out whether they're working by limiting yourself to one at a time, and using one of these questionnaires before you start and 3 months later. Oh, and keep your copies, and ask the technician at your eye doctor's office to place it in your medical records.

Friday, November 2, 2007

Study: Usefulness of OSDI

We keep saying it... we keep saying it... I hope more doctors will start employing it! This is a great, EASY, quick little tool for assessing dry eye symptoms. That the results don't correlate with Schirmer should not be thought of as a drawback - since there has always been lack of correlation between symptoms and schirmer scores no matter how you measure them.

Ocular surface disease index for the diagnosis of dry eye syndrome

Ozkura F et al, Ocular Immunology and Inflammation, 2007 Sep-Oct;15(5):389-93.

Purpose: Evaluation of ocular surface disease index (OSDI) questionnaire for the diagnosis of dry eye syndrome. Methods: Sixty-eight patients admitted to the Ophthalmology Polyclinic of the Dumlupinar University between December 2005 and April 2006 were randomly studied. The OSDI questionnaire was performed before, and the Schirmer and tear film breakup time (TBUT) tests were performed after the routine ophthalmologic examination. Results: There was a significant inverse correlation between the OSDI and TBUT test scores, but no correlation between the Schirmer test scores and OSDI (r = -.296, p = .014, r = -.182, p = .138, respectively). Although there was a significant difference between the low and high OSDI having cases according to the TBUT test scores (p = .043), there was not according to the Schirmer test scores. Conclusions: The OSDI is a standardized instrument to evaluate symptoms, and can easily be performed and used to support the diagnosis of dry eye syndrome.

And by the way, in case you don't have a copy handy, here's a link to a downloadable copy of OSDI.

Newsblurb: Thank you to a Beverly Hills "opthamalagist"

What a great state of things compared to a year ago: There is now getting to be so much mainstream press coverage of dry eye that I no longer feel obliged to post blurbs about every half-witted press report about dry eyes out of exquisite gratitude to any journalist willing to give such a dull sounding topic the time of day.

But this one caught my eye and the obsessive English major in me (ok, so I did drop out... what's your point?) could not help herself.

No cure for dry eyes, but there are many effective new treatments

She went to see Beverly Hills opthamalagist Dr. Kerry Assil because she wanted Lasik eye surgery. But he told her it would make her dry eye condition even worse.

I thought that on Dry Eye talk I had already seen every possible way to butcher the spelling of this word but...


However, my indignation over their orthography quickly gave way to pleasure at reading that someone was actually told not to get LASIK because of dry eye. Thank you, thank you, thank you.

(By the way, I wouldn't exactly describe artificial tears, Restasis, plugs and steroids as "new" treatments, but never mind.)

Update on my BSLs

Just a quick update on my Boston Sclerals for those who are interested.

I've been wearing the BSLs since June 2006, and went back for an "update" recently.

Two reasons for new lenses -
1) Poor vision in my left eye. Entirely my fault, because I had to leave the clinic earlier than scheduled when I was being fitted back in 06, so we never got a chance to either review the fit of the left lens or optimize the vision. After that I just never managed to scrape together enough time to go back to BFS and do something about it. I'm right eye dominant and was so thrilled with the vision in that eye that I just didn't make it a priority.

2) Dr. Rosenthal came out with a new lens design (the T6) that I wanted to try.

I almost hesitate to tell you how efficiently Dr. Rosenthal nailed the new lenses for me - I don't want to set expectations for anyone else, because in most cases it takes several iterations and patients need to be there for 1-2 weeks. But... I can't help gloating over what a genius he is. In both cases, he nailed it in the very first lens he made.

The T6 is awesome. Incredibly comfortable. It was good before and better now. As for the vision, well, I suppose part of my response is due to having been walking around substantially undercorrected in my left eye for more than a year but I was blown away by how well I am seeing now. I flew home Tuesday night and after a long day followed by 7 hours of WESTbound travel, I was able to DRIVE myself and my daughter home (1.5 hours away from the airport) in the middle of the night. No chance of getting sleepy at the wheel, I was drinking in how clear everything looked and enjoying not being blinded by headlights. Granted - that was with freshly re-inserted lenses so I don't by any means expect it to be that way most evenings, but at least I known it CAN be if I refill them.

Another new thing for me: I tend to get some debris under the lenses, particularly the left. Dr. Rosenthal showed me a trick to reduce this which I am going to continue experimenting with: He told me to fill the lens partway with Celluvisc and top it off with Unisol. The idea is that the added viscosity will slow down fluid exchange so gunk can't work its way under the lens so quickly. It really worked very well the day I tried it at the clinic - most intriguing. However, I hate methylcellulose and couldn't bring myself to go buy some celluvisc, so I decided to try this with Dwelle. Did it yesterday successfully. Today I was short on time and stuck with just plain Unisol so I'll see how the performance compares. I will continue experimenting with this in both eyes and see how it goes.

BFS is such an amazing place. It's always inspiring to be there, seeing people who have been in pain and/or unable to see well for years suddenly have a whole new world opened to them when they get fitted. The combination of scientific brilliance, total focus on patient experience, and compassion make that a truly unique facility.

Other BFS updates - satellite offices opening in Houston (Baylor) and LA (Doheeny) in due time. Satellite newly opened in Tokyo.

I'm working on stocking all consumables for BSL users in The Dry Eye Shop, with the exception of cheap locally available items (hydrogen peroxide and Unisol). We currently have plungers - both for insertion and removal - and Lobob cleaner, and expect soon to have Miraflow, hydrogen peroxide neutralizing tablets, new contact lens cases specifically for sclerals, and some specialized plungers outfitted with lights for people who have difficulty inserting the lenses.

Will post on update when I've had a month or two in these new T6 lenses.

Friday, October 26, 2007

Study: Benefits of flaxseed oil in Sjogrens/RA/Lupus patients

This looks to have been a decently thorough study (OSDI, Schirmer, BUT, impression cytology) and we sure need studies like this for oral supplements. I particularly like that there was no specific commercial product to be pushed (at least not that can be determined from the abstract).

Oral flaxseed oil (Linum usitatissimum) in the treatment for dry-eye Sjögren's syndrome patients

Pinheiro MN Jr et al, Arg Bras Oftalmol 2007 Jul-Aug;70(4):649-55.

PURPOSE: To evaluate if oral flaxseed oil (Linum usitatissimum), which reduces the inflammation in rheumatoid arthritis, may help keratoconjunctivitis sicca's treatment in Sjögren's syndrome patients. METHODS: In a randomized clinical trial, 38 female patients with rheumatoid arthritis or systemic lupus erithematosus associated with keratoconjunctivitis sicca and Sjögren's syndrome were consecutively selected from patients of the Department of Rheumatology of the Amazonas University Hospital. Keratoconjunctivitis sicca diagnosis was based on a dry-eye symptom survey score (Ocular Surface Disease Index - OSDI), Schirmer-I test, fluorescein break-up time, 1% Rose Bengal staining of ocular surface measured by the van Bijsterveld scale. All patients had ocular surface inflammation evaluated and quantified by conjunctival impression cytology, before and after the study. The subjects were divided into three groups with 13 (Group I), 12 (Group II) and 13 (Group III) patients. Group I received flaxseed oil capsules with a final 1 g/day dosis, Group II flaxseed oil capsules with a final 2 g/day dosis and Group III - controls - placebo, for 180 days. RESULTS: Comparing the results at the beginning and at the end of the treatment, statistically significant changes (p<0.05) in symptoms (OSDI), ocular surface inflammation quantified by conjunctival impression cytology, Schirmer-I test and fluorescein break-up time occurred in Groups I e II when compared to controls. CONCLUSIONS: Therapy with oral flaxseed oil capsules 1 or 2 g/day reduces ocular surface inflammation and ameliorates the symptoms of keratoconjunctivitis sicca in Sjögren's syndrome patients. Long-term studies are needed to confirm the role of this therapy for keratoconjunctivitis sicca in Sjögren's syndrome.

Study: Restasis in Sjogrens vs. APLD

Heh. Interesting.

So, dry eye buddies, would you rather have a wetter Schirmer strip or better feeling eyes?

Effect of topical cyclosporine on tear functions in tear-deficient dry eyes.

Jain AK et al, Annals of Ophthalmology 2007 Spring;39(1):19-25

We evaluated the efficacy of topical 2% cyclosporine drops in the treatment of tear-deficient dry eye because of acquired primary lachrymal disease (APLD; 15 patients) and Sjögren syndrome (SS; 15 patients). Symptoms of dryness tended to improve in patients with SS. Schirmer score improved in patients with APLD. Topical CsA 2% drops appears to be safe and effective in the treatment of dry eye patients because in patients with APLD and SS, there is trend toward improvement.

Study: More on immunosuppressants and...

Okay... so what have we here:
1) Something that's supposed to be better than cyclosporine or tacrolimus
2) Another plug for that drug-plug thingymabob.

I'm not sure the "can be highly effective in... dry eye syndrome" bit is simply referencing the known use of cyclosporine in dry eye or whether they're hinting that after ISA-247/LX-211's succesful clinicals for uveitis they're going after the dry eye market (note all these 'wider therapeutic window' comments). Time will tell.

Next-generation calcineurin inhibitors for ophthalmic indications.
Anglade E et al, Expert Opinion on Investigational Drugs, 2007 Oct;16(10):1525-40

Calcineurin inhibitors (CNIs) are potent immunosuppressants that reversibly inhibit T-cell proliferation and prevent the release of pro-inflammatory cytokines by blocking the activity of calcineurin, a ubiquitous enzyme that is found in cell cytoplasm. CNIs can be highly effective in immune-mediated ophthalmic diseases such as uveitis, dry eye syndrome and inflammatory blepharitis, as well as for the prevention of rejection in corneal transplants. ISA-247/LX-211 is a novel CNI that is in Phase III clinical development for the treatment of various forms of non-infectious uveitis. ISA-247/LX-211 is a rationally designed analog of ciclosporin A that exhibits more predictable pharmacokinetic and pharmacodynamic properties and a 4-fold greater calcineurin inhibition than its parent compound, ciclosporin A. ISA-247/LX-211 has been observed to be effective, well-tolerated, and safe in early clinical trials, exhibiting a much wider therapeutic window compared with classic CNIs, such as ciclosporin A and tacrolimus. An alternative approach to widening the therapeutic window for the therapy of ophthalmic disorders lies in local delivery of CNIs through polymeric implants that release the drug over long periods of time. The silicone matrix episcleral implant LX-201 is in Phase III development at present for the prevention of rejection in high-risk cornea transplantation.

Study: Another Smartplug complication

Pyogenic granuloma following Smart Plug insertion.
Arch Soc Esp Oftalmol 2007 Oct;82(10):653-6.

CASE REPORT: We report the case of a 65-year-old woman with dry eye syndrome who was referred because of a red mass in the internal left canthus. Three years previously two Smart Plugs had been introduced into both lacrimal punctums of that eye. We diagnosed a pyogenic granuloma and removed it. Two weeks later a new granuloma developed so both the granuloma and the punctal plug were removed. The patient became asymptomatic following this latter procedure. DISCUSSION: A pyogenic granuloma in a Smart Plug punctum is described. This rare complication is generally associated with the use of silicone punctal plugs, being possibly caused by the chronic irritation of the accumulated detritus and necessitating removal of the plug.

I always get irritated when I read about somebody getting two durable plugs placed in the same punctum. If there's no reliable way to figure out whether the first one is still there, is it ever safe to shove another one in?

Study: Improving contact lens tolerance on dry eyes

Well, I confess I have rather mixed feelings about this one.

On the one hand it's all very sensible and really raises some excellent points. For example, it stresses that choice of contact lens solutions may be just as important as choice of lenses. Reminds me, my sister recently found that Lobob for soft contacts dramatically improved her lens performance.

On the other hand, when read by laypeople I would worry that the details of a study like this get glossed over and instead people take it as encouragement to stubbornly persist in contact lens wear without sufficiently investigating and dealing with the ocular surface problems.

But anyway, I appreciate what appears to be quite a thorough discussion of how to improve contact lens prospects for people with mild dry eye.

Contact lens strategies for the patient with dry eye.
The Ocular Surface, 2007 Oct;5(4):294-307.

ABSTRACT Dry eye is the most common reason for contact lens (CL) discontinuation, and the patient with pre-existing dry eye presents particular challenges to the CL fitter. Poor tear film quality/stability, oxygen deprivation, lens deposits, and adverse reactions to CL solutions all contribute to dry eye, and lid disease, allergies, environmental factors, and medications can further hamper successful CL wear by the patient with dry eye. Health and comfort of the ocular surface is affected by the water content, ionicity, oxygen permeability, and modulus of elasticity of the lens, as well as by surface characteristics, such as protein, lipid, and mucin deposition; protein adsorption; and wettability. The choice of CL cleaning solutions with regard to action, cytotoxicity, and biocompatibility are as important as the choice of the CL itself. With appropriate management of the lid, meibomian gland, and ocular surface conditions that produce dry eye, careful selection of lenses and solutions, and vigilant follow-up, successful CL wear should be achievable for the dry eye patient.

Study: Dry eye, MEGS, and computer users

At last - somebody's actually published something about moisture chambers!!

Even if it is just a plug for a product just about to be commercialized. Even if they did choose a product name that screams GEEEEEK. It's still better than nothing. I've been pushing moisture chambers ever since I acquired my first pair of Panoptx. The benefits can be remarkable and in my opinion there needs to be a concerted effort to dispel the perception that they are a tool only for the end-stage incurable dry eye patient. From the manufacturers, we need products that don't look like the dreaded "dry eye goggles".

So here's the scoop. MEGS (Micro-Environment Glasses). Sigh, this poor product is screaming for marketing help, starting with the name, but never mind that for the moment.

Isolation of the ocular surface to treat dysfunctional tear syndrome associated with computer use.

Yee RW et al, The Ocular Surface 2007 Oct;5(4):308-15.

ABSTRACT Dysfunctional tear syndrome (DTS) associated with computer use is characterized by mild irritation, itching, redness, and intermittent tearing after extended staring. It frequently involves foreign body or sandy sensation, blurring of vision, and fatigue, worsening especially at the end of the day. We undertook a study to determine the effectiveness of periocular isolation using microenvironment glasses (MEGStrade mark) alone and in combination with artificial tears in alleviating the symptoms and signs of dry eye related to computer use. At the same time, we evaluated the relative ability of a battery of clinical tests for dry eye to distinguish dry eyes from normal eyes in heavy computer users. Forty adult subjects who used computers 3 hours or more per day were divided into dry eye sufferers and controls based on their scores on the Ocular Surface Disease Index (OSDI). Baseline scores were recorded and ocular surface assessments were made. On four subsequent visits, the subjects played a computer game for 30 minutes in a controlled environment, during which one of four treatment conditions were applied, in random order, to each subject: 1) no treatment, 2) artificial tears, 3) MEGStrade mark, and 4) artificial tears combined with MEGStrade mark. Immediately after each session, subjects were tested on: a subjective comfort questionnaire, tear breakup time (TBUT), fluorescein staining, lissamine green staining, and conjunctival injection. In this study, a significant correlation was found between cumulative lifetime computer use and ocular surface disorder, as measured by the standardized OSDI index. The experimental and control subjects were significantly different (P < 0.05) in the meibomian gland assessment and TBUT; they were consistently different in fluorescein and lissamine green staining, but with P > 0.05. Isolation of the ocular surface alone produced significant improvements in comfort scores and TBUT and a consistent trend of improvement in fluorescein staining and lissamine green staining. Isolation plus tears produced a significant improvement in lissamine green staining. The subjective comfort inventory and the tbut test were most effective in distinguishing between the treatments used. Computer users with ocular surface complaints should have a detailed ocular surface examination and, if symptomatic, they can be effectively treated with isolation of the ocular surface, artificial tears therapy, and effective environmental manipulations.

New drug news: Alcon / Lantibio and HLA

Once a dry eye drug gets to a certain point in clinicals it's only a matter of time till you hear a big ophthalmic pharma's name connected with it. And considering Alcon's meager dry eye offerings, I'm even less surprised to see that they jumped at the chance to market Lantibio's drug (currently in phase III clinicals) in the US.

Hyaluronic acid drops of various sorts are available as over-the-counter lubricants around the world but not in the US because HLA is not included in the FDA's monograph for ophthalmic demulcents (that little-known and poorly understood way the FDA has of regulating over-the-counter eye lubricants). Probably no one living remembers the last time anyone tried to change that monograph and these days, no one would be motivated to try, because selling drops on a prescription basis is a far more shareholder-friendly idea.

I never actually saw a news release on Alcon's deal with Lantibio and TRB... just saw it buried in their third quarter results announced a few days ago.

New drug news: Re-inspired.

You've got to hand it to them for persistence. Prolacria is not going away, at least not yet.

Inspire tries again with dry eye drug

The News & Observer, Oct 20 2007

Inspire Pharmaceuticals hired a Massachusetts company to test its troubled dry-eye drug, Prolacria.

The medicine has been in regulatory limbo since it failed the second of four clinical trials two years ago.

Prolacria has been tested on 2,000 patients with mixed results. After talks with the Food and Drug Administration, Inspire said in a regulatory filing that it will test the effectiveness of the drug in a particular part of the eye.

Inspire has agreed to pay Ophthalmic Research Associates of North Andover, Mass., up to $34.5 million if the test results get Prolacria regulatory approval.

News & controversy: Patenting damaged rabbits for use in dry eye research?

(Sorry, I'm a couple months late on this one.)

Now I've heard everything. I don't even think I can trust myself to comment on this, so I'll just provide links and quotes.

Can an animal be patented?

Here's a link to the patent application.

Newsblurb: Canine dry eye

Just for a change of pace, I thought I'd post about a veterinary Q&A on canine dry eye that caught my eye. Kind of eye-opening, because doctors are apparently rather more blunt about prognosis and treatments when they're talking about your pooch than about you:

Dog's eye requires lubrication
(Detroit News, Oct 13 2007)

The problem with KCS in younger dogs is that it is more likely to be a case of abnormal or lack of development of the lacrimal gland. Clinical signs may vary considerably between dogs, but typically include ocular discharge, a dull-appearing corneal surface, red eye and failure to open the eye. Corneal changes may include ulceration, vascularization, pigmentation and scarring...
...You will most likely be treating this condition for the rest of the dog's life.

News: Ulster Herald on dry eye

If we think dry eye news coverage is inadequate in the US... well, we're actually doing pretty well compared to many other places. I was very pleased on behalf of our Dry Eye Talk friends in northern Ireland to see this piece:

Not a dry eye in the house

(sigh, every journalist seems to think that is clever)

It's rather, er, barebones, but hey, any coverage is better than no coverage.

Dry eye syndrome is an extremely common condition in which symptoms can range from subtle irritation to inflammation of the tissues of the eyes.

Tears are essential for good eye health since they wash out dust and debris, keep the eye moist and neutralise bacteria that colonise the eye.


In dry eye syndrome, the eye doesn't produce enough tears, or they evaporate off the eye surface too quickly.

The resulting effect can be a gritty, burning or itchy sensation. Occasionally, people complain of excessive watering of the eyes when the tissues try to overcompensate for the lack of moisture.


There are many causes of dry eye syndrome. Many medications, such as antihistamines or oral contraceptives , can cause dry eyes as a side effect, as can general health complaints such as rheumatoid arthritis and rosacea.

Eyes become dry as a natural part of the ageing process, especially during the menopause.

Symptoms can be exacerbated by environments such as central heating, air conditioning , or using the computer for a long period of time.


Dry eyes per se cannot be cured, but the symptoms can be managed. Artificial tears can be used to lubricate the ocular surface, while air humidifiers can add moisture to air that's been heated or conditioned. Silicone plugs can be used to block lacrimal (tear) ducts and retain your natural tears on your eye.

Essential fatty acids can reduce dry eye problems, cold water fish, and flax seed oil may also be beneficial.

If contact lenses are the cause of dry eyes, your contact lens practitioner may switch you to a different lens material.

If you are considering LASIK , dry eyes may disqualify you for the surgery.

New drug news: Civamide in Phase III and acquired by OPKO

Wow, a new one slipped in right under the radar. Well, the more the merrier.

OPKO Health Acquires Rights to Clinical Stage Compound for Dry Eye (October 10, 2007)

The compound, civamide, a proprietary TRPV-1 receptor modulator and neuronal calcium channel blocker, is in Phase III clinical trials in an intranasal formulation to treat various types of pain. Increased tear production was observed in over 50% of the patients receiving civamide, and no systemic side effects were noted. Preliminary evidence suggests that civamide's effects on tear production result from its ability to modify signal transduction pathways present in the human lacrimal gland.

At first blush I kind of wonder how dry eye patients will feel about putting an arthritis treatment up their nose, but then, there's a lot of desperation in the dry eye crowd. If it works, well, I'm sure they'll have a market.

Corporate news: QLT/Forsight Newco acquisition & that new punctal plug technology

This is not directly related to dry eye but this emerging technology about a punctal plug drug delivery system is kind of intriguing (as well as worrying, frankly). Stay tuned on this one.

QLT hits 52-low on eye deal - October 9, 2007

As the first clinical candidate utilizing this cutting edge platform technology, it will target glaucoma, by replacing eye drops, dry eye, allergies and postoperative care. The company expects the products to represent a $6 billion market.

News (not): "New look for LASIK surgery"

I can hardly believe newspapers are still cranking out this kind of thing. Musta been an awfully slow news day in Colorado.

...a 30-year-old outdoor enthusiast in Boulder, long wanted to undergo laser eye surgery so he could ditch the glasses he's worn since the fifth grade.

But it wasn't until recently that laser eye technology became good enough to correct Schaffer's severe astigmatism, a vision problem caused by an irregularly shaped cornea...
During the 10-minute outpatient procedure, Schaffer's surgeon... used a new technology called the IntraLase laser to create a flap in the surface tissue covering each of Schaffer's corneas. Then he used an excimer laser to correct the shape of the corneas, which play a crucial role in reflecting light onto the eyes' retinas.

(Rocky Mountain News, Oct. 2, 2007)

SNORT. New technology? Come on folks. Intralase launched their fourth generation machine in 2006. Femtosecond technology is not new. It's just that it's taken many surgeons till now to amortize their excimers enough to afford one.

But, ahem, forgive my digression from dry eye. Here's what really caught my eye:

Understand the risks: Laser eye surgery provides good results for the vast majority of patients, but complications such as severe dry eye, halos, glare, double vision and vision that worsens at night can occur. The probability of serious long-term complications is less than 0.5 percent.

These sorts of combination statements really bother me because while each individual statement might be defensible or explainable, the overall impression conveyed is false. A normal ignorant consumer would read this and have no way of knowing that "serious long-term complications" does NOT refer to the complications named in the previous sentence - which, according to years of medical studies, clearly have a considerablyl greater than 0.5% rate of occurrence.... My point being that a normal consumer would read this and conclude that they have an 0.5% or less chance of getting severe dry eye.

Sorry, but that's just plain wrong. Read the literature. Heck, read even a standard consent form.

Study: Contamination of ophthalmic solutions (hmm... have we got a solution for you)

Ran across an Ocular Surgery News report on a British Journal of Ophthalmology study (October issue) which found a pretty frightening 8% of eyedrops - particularly steroids, but also including a couple of drops for dry eyes, presumably OTC lubricants - that were in use at a long-term-care facility were contaminated.

One of the comments of the authors:

The frequent contamination during reuse of certain steroid-containing ophthalmic solutions raises the question of whether single-use solutions might be preferred for these and other classes of ocular drugs

Hey, any study that will help encourage development of unpreserved unit doses of any and all prescription eyedrops is welcome around here. Keep it up boys & girls.

Thursday, October 18, 2007

New drug news: ALTY-0501 update

According to a recent press release (PDF), Alacrity Biosciences' ALTY-0501 has had some positive results in its Phase II study.

ALTY-0501 is basically a very low dose topical doxycycline aimed at "preventing the disruption of the epithelial barrier on the ocular surface".

Study design sounded kind of interesting:

The Phase 2 study utilized the controlled adverse environment (CAE) chamber to measure dry eye patients' ability to withstand a stressful drying environment on the eye, and patient diaries to measure the severity of their dry eye symptoms over the course of the study. Patients were randomized to receive ALTY-0501 or its vehicle four times each day over the course of a 56 day study.

Like all dry eye testing they seek to demonstrate improvement in both signs and symptoms. In this case, "signs" were exclusively staining (numbers for total, superior and nasal were reported), and "symptoms" of burning, stinging and grittiness were somehow gleaned from patient diaries (sure would like to know how that was structured!).

Alacrity are hoping to move forward with Phase III clinicals in early 2008.

Wednesday, October 17, 2007

Eyewear news: Wiley-X, Panoptx & more

Oh my goodness, is it really more than a month since I last blogged?? I am so sorry. Things are just so busy around here. I really will try to be more regular about this though.


A few updates from the world of dry eye eyewear...

1) Next week I'm expecting to meet with Panoptx' sales director to preview their new products coming out at the beginning of 2008. I'm excited about this and looking forward to seeing what's new. I'll post here and on dryeyetalk after I get a looksee.

2) According to a recent press release, Wiley-X is outlicensing their climate control facial cavity technology to Bushnell, who make the Bolle and Serengetti eyewear lines. Meaning, HOPEFULLY, that the same type of seal used on the current Wiley-X Climate Control frames will be incorporated in more eyewear options in the relatively near future, which should be good news for us.

3) No word on timing of the MEGs release yet but fingers crossed that they are coming soon. They won't come before they're wanted, that's for sure.