FDA Panel Debates New Guidance for Proper Use of Contacts

Larry Hand

May 14, 2014

When revising guidelines for manufacturers of contact lenses and lens care products, US Food and Drug Administration (FDA) staff members should not require the industry to be responsible for patient noncompliance with using products as directed.

That was the central message Tuesday from the Ophthalmic Devices Panel of the FDA's Medical Devices Advisory Committee.

However, the debate is still on as to whether to use tap water to rinse contact lenses before inserting them into eyes. The panel was split on whether enough evidence has been presented isolating water as a primary source for lens complications.

Members of the FDA's Division of Ophthalmic and Ear, Nose, and Throat Devices committee have been researching possible guideline changes since right after 2 keratitis outbreaks. Suspected cases of Fusarium keratitis in 2006 led to the voluntary recall of a multipurpose solution for contact lenses. And when cultures from 138 patients tested positive for Acanthamoeba keratitis in 2007, another multipurpose solution was voluntarily recalled.

The FDA published the last premarket guidelines for daily wear of contact lenses in 1994 and the last premarket guidelines for contact lens care products in 1997. "Over the past 10 years, outbreaks of infectious microbial keratitis, new and emerging lens and solution technologies, as well as evidence of potential lens-solution incompatibilities have resulted in an increased effort to update our testing paradigm to reflect current knowledge and to ensure that current products remain safe and effective," staffers wrote in a panel briefing.

They recommend premarket testing be more than doubled, going from comparing lens and solution compatibilities from just conventional hydrophilic material lenses to including newer silicone hydrophilic lenses, and going from 4 lens types to 9 lens types, defined by water content and ionic vs nonionic types.

80% Noncompliance

Staff members explained to panel members that about 80% of lens wear complications result from patients not complying with directions on how to wear and care for lenses compared with about 25% noncompliance for general medical care.

Specifically, contact lens noncompliance issues include using solutions longer — sometimes much longer — than product instructions specify and topping off solutions with water after they get diluted.

When staff proposals were offered to panel members to consider, including the new grouping of lenses to be tested and a recommendation to increase the number of test patients industry had to use to prove a product is ready for market, they received mixed responses.

Panel members voiced concerns such as whether too many categories and increased test participants might be burdensome and troublesome to industry, but staffers advised that the number of test participants has been in practice for 9 years already, with no pushback from industry.

When staff members asked whether including a requirement that preservative concentrations in solutions remain within the manufacturer's specifications after the recommended soak time, panel members advised that this sends a mixed message to users and that directions should explicitly say that solutions should be used once only.

Panel members did advise, however, that manufacturers be required to list in the instructions, in bold or bold underlined, as to whether a particular solution is incompatible with particular lenses offered, and to consider in the future including such specifications in additional languages other than English.

Water or No Water

Staff members pointed out that exposure to water while wearing contact lenses has been associated with the development of Acanthamoeba keratitis, but many makers of rigid gas-permeable lenses continue to recommend use of water for rinsing. They also pointed out that contact lens–related "Acanthamoeba keratitis continues to be a small but significant cause of infection."

Panel members were widely split on this issue, with some saying not enough evidence existed that isolated tap water as the primary source of complications and others saying the evidence is there. In addition, several panel members said, simply, no good substitute exists for tap water, although untreated tap water can be a problem.

"I don't know how we can regulate that," said Ronald J. Zabransky, PhD, from Case Western Reserve University, Cleveland, Ohio.

"Zip code may be more important than anything else as a source of water," said Eve J. Higginbotham, MD, from the University of Pennsylvania Perelman School of Medicine, Philadelphia, and chair of the panel.

The advisory committee members have disclosed no relevant financial interests.


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