I recently read an advertisement implying that new research is better than older research, and thus, the older research should be superseded. While this is sometimes true, I am not quite sure that I completely buy that argument—something newer is not necessarily better. I think we can all think of examples of this from our everyday lives. This sort of comment suggests to me that we all need to be vigilant in our scrutiny everything presented to us—both advertisements and original research.

Menicon Z (tisilfocon A) gas permeable contact lens material from by Menicon Co., Ltd. received an expanded indication from the U.S. Food and Drug Administration for management of irregular corneal conditions (in non-diseased eyes) including keratoconus, pellucid marginal degeneration, post penetrating keratoplasty, post radial keratotomy and post LASIK surgery.

The expanded indication positions Menicon Z as a hyper-oxygen delivery (Dk 163) option for the management of irregular corneal conditions. Menicon Z is currently available to authorized Menicon Z manufacturers in standard sized blanks. Within the coming weeks, the company will release a large diameter, 16.5mm blank for sale to authorized laboratories.

SARcode Bioscience, Inc., a privately-held biopharmaceutical company, announced that the initial patient has been enrolled in the company's pivotal Phase 3 clinical study (OPUS-1) of SAR 1118 ophthalmic solution.

According to the company, SAR 1118 is a first-in-class molecule that inhibits T-cell inflammation by blocking the binding of two key cellular surface proteins (LFA-1 and ICAM-1) that mediate the chronic inflammatory cascade. SAR 1118 may be able to reduce inflammation associated with dry eye disease.

The OPUS-1 trial will study the safety and efficacy of SAR 1118 in the treatment of dry eye disease. Approximately 588 patients will be randomized to receive SAR 1118 5.0% ophthalmic solution or placebo twice daily over 12 weeks. The co-primary endpoints of the study are corneal fluorescein staining score and visual-related function score (reading, driving at night, computer use, and watching television) as measured by the Ocular Surface Disease Index (OSDI), a validated instrument designed to assess the impact of dry eye upon vision-related activities. The safety and tolerability of SAR 1118 compared to placebo at 12 weeks will also be evaluated.

Contamac Ltd announced that the United States Patent and Trademark Office issued a patent for the protection of its proprietary silicone hydrogel polymer materials, including the flagship Definitive contact lens product. The patent covers polymer composition, formulation design, production and contact lens manufacturing, including the provision of an indication for finished contact lenses resulting from the production process.

The Definitive material was developed for specialty contact lens application with its unique high water content and low modulus promoting on-eye comfort throughout the day, according to the company. Contamac has sold over 800,000 units of this innovative product worldwide, and it is currently available in the U.S. market through Art Optical, Metro Optics, Unilens and X-Cel/Walman contact lens laboratories.

InSite Vision Incorporated announced the appointment of a new Scientific Advisory Board (SAB) to help guide and shape its research programs in the development of novel ophthalmic medicines. Members of InSite's SAB represent leaders in ophthalmic research, treatment and clinical drug development, including Richard Lindstrom, MD, Gary Foulks, MD, Michael Lemp, MD and Kelly Nichols, OD, MPH, PhD. The SAB will be led by InSite's Chief Medical Officer, Kamran Hosseini, MD, PhD and Brian Levy, OD, a member of InSite's Board of Directors, will also participate in all SAB meetings.

Adrian S. Bruce, BScOptom, PhD, FAAO, FVCO has published Anterior Eye Disease and Therapeutics A-Z, 2nd edition, with co-author Dr. Michael Loughnan, an ophthalmologist and senior staff specialist at the Royal Victorian Eye and Ear Hospital in Australia. The new edition includes updates to the treatment of contact lens related complications as well as other anterior eye disorders.

This textbook offers succinct descriptions of over 160 anterior segment eye conditions - from Bacterial Conjunctivitis to Floppy Eyelid Syndrome and Vitamin A Deficiency - including seven new conditions. Each anterior segment eye condition is supported by full color clinical photographs, along with treatment protocols, down-to-earth advice, differential diagnoses and/or therapy alternatives.

For more information, visit http://www.us.elsevierhealth.com/product.jsp?isbn=9780729539579.

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This is a photograph of Granular Corneal Dystrophy. Its mode of inheritance is autosomal dominant and it appears during the first or second decade of life. This dystrophy shows a pattern of gray/white opacities. It is common for this condition to cause corneal erosions and therefore pain. Common treatments include bandage contact lenses or penetrating keratoplasty, depending on severity.

We thank Dr. Davila-Garcia for his image and welcome photo submissions from our other readers! It is easy to submit a photo for consideration for publishing in Contact Lenses Today. Simply visit http://www.cltoday.com/upload/upload.aspx to upload your image. Please include an explanation of the photo and your full name, degree or title and city/state/country.

Still Recommending No-Rub?

A recent study reported on comparative anti-microbial efficacy of three regimens using three different "No-Rub" multipurpose solutions on three different soft lens materials. The three regimens were: 1) no rub, no rinse; 2) rinse only; and 3) rub and rinse. Not surprisingly, the rub and rinse regimen was most effective for all solutions and all materials. But there were differences among the various solutions and materials for the other two regimens.

Though this was an in vitro evaluation, it does have clinical implications. First, I believe that a rub and rinse regimen should be recommended for all patients, even if they are using a solution approved for "No-Rub", to attain maximum disinfection. Second, though there may be some lenses where "no rub, no rinse" may disinfect adequately, it is impossible to know which lenses they are. Plus, there is so much variability in the ocular environment across patients that these results may not be applicable to any particular patient. Recommending rubbing and rinsing to all patients is the best way to make sure that all patients are wearing the cleanest possible lenses.

Zhu H, Bandara MB, Vijay AK, et al. Importance of Rub and Rinse in Use of Multipurpose Contact Lens Solution. Optom Vis Sci. 2011; 88(8): 967-972.

RESEARCH REVIEW
Loretta B. Szczotka-Flynn, OD, PhD, MS, FAAO

Improved Methods to Measure Corneal Surface Cells

Measuring ex vivo corneal cells has always been challenging for researchers due to issues surrounding the collection methods. Previous methods of non-invasive, irrigative corneal cell collection resulted in low cell yields limiting potential analysis. Other more invasive methods such as impression cytology are either impractical or scientifically limited. Peterson and coworkers have updated a previous concept of an apparatus and invigorated its utility to collect human corneal epithelial cells from direct irrigation of the corneal surface.

So far they have been able to use their apparatus to collect human corneal epithelial cells with significantly higher yields, and greater specificity than previously reported. The technique produces reduced corneal staining post eye-wash which they claim demonstrates the safety of the technique and its ability to remove cells directly from the corneal surface. Look for more reports on this technique to provide objective non-invasive methods of investigating pathological changes, effects of topical therapeutics, and impact of contact lenses and care-solutions on the cells of the ocular surface.

Peterson RC, Gorbet M, Cira D, Amos C, Woods CA, Fonn D. Non-Invasive Collection and Examination of Human Corneal Epithelial Cells. Optom Vis Sci. 2011 Sep 1. [Epub ahead of print]

It all began with patient complaints: normal, healthy, well-adjusted, and compliant soft contact lens wearers began coming in for their periodic follow-up exams complaining that something wasn't right with their lenses. Wearing time was down because of comfort issues. Artificial tears were not helpful (are they ever?). Mild but unflagging irritation was the rule of the day.

Clever doctors examined the fit, movement, positioning of their patients' planned replacement or longer term soft contact lenses. In general they were happy with what they saw. That is, until they had their patients remove their lenses and applied fluorescein stain. Areas of the sore corneas lit up like neon signs.

Even cleverer doctors (independent of manufacturer best interests) began to study the relationships between various lens materials and solutions in a regulated and controlled fashion. They found that certain combinations seemed to be bad 'statistically' for the corneal epithelium. That is what they think and it seems reasonable even in light of the research of Dr. Bright as presented last week in Contact Lens Today by Dr. Gromacki.

Dr. Bright has reported that a preservative found in the most offending solution is more likely to bind with fluorescein causing "preservative-associated transient hyperfluorescence (PATH...by sodium fluorescein binding with the multipurpose solution preservative and accumulation at the ocular surface." The binding produced moieties are released into the tear film.

But, wait... the corneas were irritated before the fluorescein was added to the mix. A careful inspection with white light before staining can show the areas which will stain in advanced cases. The fluorescein was instilled after the lenses had been removed. And, what is the part played by the contact lens material in producing the SICS.

I am sorry that I do not have access to the original work. I would be curious to know how Drs. Bright, et al. showed that in fact there was no corneal insult. Do they want us to believe that the PATHs are not signs of corneal irritation but only short term results of the application of fluorescein which will wash off with the next drop of solution? I don't think that is what the contact lens wearers experience shows.

In any event, with all the respect that Dr. Bright's work deserves, how do they deal with the patient's chief complaint? And, more than that: when offending solutions/lens combinations are detected and rectified, how do they explain the relief of symptoms?

Inquiring minds...

Bezalel Schendowich, OD
Chairperson and Education Coordinator, JOS
Sha'are Zedek Medical Center, Jerusalem, Israel

This study was conducted to evaluate whether polyunsaturated fatty acids (PUFA) such as γ-linolenic acid (GLA) and eicosapentaenoic acid (EPA), as found in the diet, may affect the lipid composition of conjunctival epithelium and whether these modifications affect prostaglandin (PG) production after inflammatory stimulation.

Chang and IOBA-NHC conjunctival human cells were treated with GLA and/or EPA at 5, 10, 20, 30, 40, or 50 μg/ml for 72 hours and then were stimulated with interferon-gamma (IFN-γ) for 48 hours. Changes in the composition of neutral lipids and phospholipids were monitored by gas chromatography. PGE1 and PGE2 levels were measured by enzyme immunoassay.

PUFA supplementations in the culture medium induced incorporation of these fatty acids and of their metabolites in neutral lipids and phospholipids of the conjunctival cells. The fatty acid composition of neutral lipids and phospholipids was not affected by stimulation with IFN-γ. The production of PGE1 and PGE2 was affected by GLA supplementation whereas it was not modified by EPA supplementation. A combined supplementation of EPA and GLA did not change the production of PGE1 but decreased the production of PGE2.

The authors concluded that these results suggest that modulation of fatty acid composition and PG production by PUFA supplementation is possible in the conjunctival epithelium, which is an important site of inflammation in dry eye syndrome.

Viau S, Leclère L, Buteau B, Grégoire S, Acar N, Bron A, Creuzot-Garcher CP, Bretillon L, Joffre C. Polyunsaturated fatty acids induce modification in the lipid composition and the prostaglandin production of the conjunctival epithelium cells. Graefes Arch Clin Exp Ophthalmol. 2011 Sep 6. [Epub ahead of print]
Source: UMR CSGA 1324 INRA - 6265 CNRS - Université de Bourgogne — AgroSup Dijon, Eye and Nutrition Research Group, 21000, Dijon, France.

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