Recommendations offered on contact lens product testing, lens care guidelines

WASHINGTON — A coalition of ophthalmic organizations stressed the importance of improving contact lens product testing and adapting standardized lens care guidelines for consumers during a presentation before a U.S. Food and Drug Administration panel yesterday.

These recommendations follow the voluntary recalls of contact lens solutions linked to keratitis outbreaks in 2006 and 2007, as well as reports that the number of microbial keratitis cases, namely cases of Acanthamoeba keratitis, remains steady among contact lens wearers, according to a joint press release from the coalition, which includes the American Academy of Ophthalmology, the Contact Lens Association of Ophthalmologists, the Cornea Society and the American Society of Cataract and Refractive Surgery.

"Now is the time to tighten the safety net around contact lens products," said Elmer Tu, MD, AAO spokesperson and director of the cornea and external disease service at the University of Illinois at Chicago. "While improved testing and consumer awareness of lens care guidelines may not prevent future outbreaks of eye infections, they will provide an important additional layer of safety for contact lens wearers."

The coalition recommended that the FDA work closely with the eye care industry to broaden and strengthen contact lens solution and product testing. Specifically, the committee stressed the need to adapt a more rigorous, standardized testing protocol to ensure that contact lens solutions are effective against a more diverse selection of infectious organisms, including Acanthamoeba. In addition, the panel urged the FDA to include "real world" scenario tests evaluating the effectiveness of contact lens solutions within contact lens cases, as well as their effectiveness after they have evaporated.

The coalition urged the FDA to halt equivalency testing — the practice through which new contact lens solution formulations are evaluated based on their similarities with existing, FDA-approved products — and stressed the need for all new products to be tested independently, according to the release.

Because infections such as Acanthamoeba keratitis and Fusarium keratitis are not normally tracked by federal health authorities, the coalition recommended that the FDA panel consider the viability of developing a mechanism for monitoring contact lens infections and the frequency and distribution of the infectious organisms that cause them.

"The exact factor or combination of factors that has led to the outbreaks of keratitis remain unclear," Dr. Tu said. Other causes, such as using extended wear lenses, reduced tear exchange under the lens with current designs, environmental factors and poor hygiene, may be of equal or greater importance and worthy of further research, he said.

The coalition outlined a list of lens care guidelines consumers should follow, including proper cleaning, rinsing and rubbing practices, avoiding lens contact with water, the correct maintenance and replacement guidelines for contact lens cases, as well as the proper maintenance of contact lens solution, according to the release.

The group also voiced its concern over the practice of "passive verification" of contact lens prescriptions, through which third-party vendors often sell expired or incorrect prescriptions without the approval of eye care professionals. Passive verification may also extend the period between eye exams, which inadvertently increases eye health risk, the release said.

The FDA is currently reviewing the safety and effectiveness of contact lens and lens care products already on the market, and it is expected to endorse the panel's recommendations, according to reports.

A complete list of all the recommendations made to the FDA about pre-clinical product testing and consumer lens care guidelines can be found at www.aao.org.