Medical Device Daily Washington Editor

GAITHERSBURG, Maryland — If you're tired of wearing glasses, you may want to think twice before switching to contact lenses unless you're very hygiene-conscious.

Persistent reports of inflammation of the cornea, or keratitis, in connection with contact lenses prompted Tuesday's meeting of FDA's ophthalmic devices advisory committee, and while the panel did not explicitly state that makers of contact lens solutions should come up with a more idiot-proof way to ensure that lenses are sterile, the subtext was certainly there and a member of the agency who presented at the panel hinted as much.

Keratitis, usually caused by an infection with the Fusarium genus of bacteria, hits about 30,000 Americans yearly, and contact lens wearers, numbering about 34 million, are 80 times more likely than others to contract the condition. However, the Acanthamoeba, a protozoan that originates in soil, also can trigger keratitis and a sufficiently damaged cornea may have to be excised and replaced with a corneal transplant.

The problem also is partly due to the fact that wearers often are inclined to skip steps in the care of their lenses, which should be rubbed as well as rinsed, although many wearers rely only on rinsing.

FDA announced a May 2006 recall of ReNu with Moisture Lock, a lens rinse solution made by Bausch & Lomb (B&L; Rochester, New York), which resulted in a drop of the incidence of Fusarium-related cases of keratitis, but the numbers subsequently spiked again.

Then last year, the incidence of Acanthamoeba keratitis surged, this time apparently in relation to the use of Complete MoisturePlus solution, made by Advanced Medical Optics (Santa Ana, California), the subject of a recall in May 2007 (Medical Device Daily, May 30, 2007).

Glenn Davies, OD, an employee of B&L who spoke on behalf of the Contact Lens Institute (CLI; Raleigh, North Carolina), said that while "CLI supports enhancements of products," data collection efforts on the efficacy of contact lens solutions on lenses is complicated by the wide range of lens types on the market.

"CLI will carefully consider the comments and recommendations expressed in today's proceedings," Davies said, but added that the association believes "that development of a test method should be given the highest priority." He said that a standard test method should specify the cleaning procedure to be used, test organisms and evaluation criteria, but "these remain outstanding issues."

Davies also said that silicone hydrogel lenses may have to be tested differently from other hydrogel lenses. "Any proposal for testing of silicone hydrogel lenses" should account for differences in how they react to solutions and how they dry.

"I want to emphasize CLI's willingness to participate in a cooperative process," but such changes should "be based on sound science," Davies said.

Art Epstein, OD, a private practitioner in Phoenix, who chairs the cornea and contact lens section of the American Optometric Association (St. Louis), said "[o]ne of the most important things we have to do is not lose sight" of the need for industry, government and physicians to make lenses safer for patients. However, "like all medical devices, there is some element of risk," he said, adding "I think this is a very important moment in the history of contact lenses."

"Compliance has been an issue in connection with these outbreaks," Epstein said, and "has been poor" since contact lenses first came out. "We've attempted to deal with this ... but unless we can change those patients, we need to adapt to" lens cleaning behaviors as they are.

Bernard Lepri, OD, of FDA's Office of Device Evaluation, told the panel, "the products and regimens of care of contact lenses are ... diverse," which has done little to clarify cleaning protocols.

"Considering the millions who wear contact lenses" and the variety of cleaning routines, "it's a wonder there are not more" adverse events, Lepri said, adding that several studies indicated that of the almost 760 million visits to doctors for all purposes in 2000, more than 180 million were due to non-compliance with doctor's orders.

This problem is especially conspicuous among wearers of contact lenses. A study also indicated that more than 54% "considered themselves to be poor wearers" in terms of lack of compliance with cleaning recommendations. Lepri said that in another study, almost 75% of those who had worn the lenses for more than 2-1/2 years described themselves as less than fully compliant with lens care guidelines, a trend that holds even when compliance is made easier.

Lepri said manufacturers should try to account for these "human factors" when formulating solutions in the future. He said "the use of a discard date [on the product label] is recommended because patients use the product long after the expiration date has passed."

The panel's discussions included recommendations that FDA require manufacturers of solutions test their products across a wider range of pathogens, including the Acanthamoeba, and to require that product labels revert to a recommendation that users both rub and rinse their lenses, rather than just rinse them.

At one point, the panel threw around the idea of warning wearers of contact lenses that they might want to remove lenses when active in fresh water sources, such as lakes and streams, and even in the shower.

Panelist William Mathers, MD, a professor of ophthalmology at the Oregon Eye Institute (Portland, Oregon), said flatly, "people are not going to do that," but that FDA could require that lens solution labels "recommend that if they do, they immediately remove and dispose of those lenses" or "immediately clean them."

The committee chairman, Neil Bressler, MD, a professor of ophthalmology at the Wilmer Eye Institute (Baltimore, Maryland), chimed in, that "it is a lot to say we want you to remove" lenses because there are risks associated with poor vision while swimming or skiing.

The question of the sanitary status of lens cases also arose, but the panel said it lacked sufficient data to make any recommendations.