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Lens solution panel urges stronger testing, labeling
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A panel of eye care experts advising the U.S. Food and Drug Administration has recommended that the agency adopt stricter contact lens product testing and develop standardized lens care guidelines for consumers.
Some of the specific recommendations, which were presented in Washington, include a warning against reusing solutions, exposing contact lens cases and contact lenses to water, and not rubbing and rinsing lenses.
The panel agreed that a clear, stringent warning should be included on contact lens care products against reusing or “topping off” solutions.
The panel also advised against exposing lens cases to any types of water and conveying the risk of eye infection when a contact lens becomes exposed to water. It also recommended that rubbing and rinsing instructions should be included on product labeling, although panel members could not agree on a set amount for the duration.
“We don’t necessarily have the data right now to give a time,” panel member Neil M. Bressler, MD, said. “I presume that if everyone started rubbing and rinsing, that might be a step in the right direction.”
The panel also agreed that companies should test solutions against Acanthamoeba as a rule, as well as other bacteria and fungi.
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 a coalition that includes the American Academy of Ophthalmology, the Contact Lens Association of Ophthalmologists, the Cornea Society and the American Society of Cataract and Refractive Surgery.
Elmer Y. Tu, MD, director of the cornea and external disease service at the University of Illinois at Chicago, spoke on behalf of that consortium during the open public hearing session. “Experts agree that the rates of microbial keratitis, in general, have not substantially declined, despite the evolution of contact lens disinfection systems over the past 2 decades,” Dr. Tu said.
He recommended that the FDA require a discard date on all contact lens care products, in addition to the expiration date, and the panel later agreed to suggest that to the FDA.
J. James Thimons, OD, a PCON Editorial Board member, spoke to the panel about corneal staining and its role in predicting the best combinations of solutions and contact lenses.
“No single element is capable of defining the risk our patients undergo,” Dr. Thimons said. “There is minimal evidence that correlates the data from a variety of sources, many of which have authored opposing views, on the subject of corneal staining and the eventual development of microbial keratitis (MK) as it relates to contact lens wear. I feel it is incumbent on eye care professionals to demand a definitive study on this issue that will aid them in addressing the concerns that have been raised relative to staining and MK and to deliver this assessment in a nonbiased and independent fashion.”
The panel said there was not enough information about the implications of corneal staining to endorse a recommendation.
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.
A complete list of all of the recommendations made to the FDA about preclinical product testing and consumer lens care guidelines can be found at www.aao.org.
For more information:
- Neil M. Bressler, MD, can be reached at the Department of Ophthalmology, Wilmer Eye Institute, 550 N. Broadway, Suite 115, Baltimore, MD 21205-2002; (410) 955-8342; e-mail: nmboffice@jhmi.edu.
- Elmer Y. Tu, MD, can be reached at University of Illinois Eye and Ear Infirmary Department of Ophthalmology, 1855 W. Taylor St., Chicago, IL 60612; (312) 355-4248; e-mail: etu@uic.edu.
- J. James Thimons, OD, can be reached at Ophthalmic Consultants of Connecticut, 75 Kings Highway Cutoff, Fairfield, CT 06430; (203) 257-7336; fax: (203) 330-4958; e-mail: jthimons@sbcglobal.net.