7-Day Limit for Wearing Contact Lenses Urged by FDA

The Food and Drug Administration recommended Wednesday that consumers who use extended-wear contact lenses or disposable lenses keep them in their eyes no longer than seven days at a time, warning that the currently approved wearing time of 30 days poses “too high” a risk of developing corneal lesions that can lead to blindness.

The federal agency urged all manufacturers of extended-wear lenses--which are worn by an estimated 5 million Americans--to voluntarily relabel their products to reflect the recommendation. It said that it also has written to 60,000 eye care professionals in the nation, asking them to tell patients who already own lenses about the change.

Each lens manufacturer has 10 days to respond to the FDA request, although the manufacturers already have agreed “informally” to comply, the agency said.

Relabeling Begins

The Contact Lens Institute, which represents the six largest manufacturers of soft contact lenses, said that the organization had asked its members in May to begin relabeling their products to recommend the shorter wearing time.

“Industry surveys have shown that eye care practitioners have been gradually shortening wearing times for their patients,” said Glen Bradley, president of CIBA Vision and chairman of the institute. “This recommendation simply captures a trend started several years ago. . . .”

The recommendation was based on a new study, sponsored by the Contact Lens Institute and conducted by the Massachusetts Eye and Ear Infirmary of Harvard Medical School and Abt Associates of Cambridge, Mass., which showed that the risk of developing ulcerative keratitis is five times greater for extended-lens wearers than for those who wear conventional daily wear lenses.

Painful Infection

Ulcerative keratitis is a painful infection that results in the formation of lesions on the cornea of the eye--the transparent tissue that forms the outer coat of the eyeball--and can eventually destroy vision.

“The data did not identify a wearing time that will eliminate the risk altogether but seven days represents a short, easy-to-remember interval which will encourage users to remove their lenses and clean them,” said Dr. Frank E. Young, commissioner of the FDA.

Ulcerative keratitis also has been associated with careless cleaning and care of lenses and lens equipment, the agency said.

“People who were careful about lens care significantly reduced their risks,” the FDA said in a statement describing the study results. “Adequate cleaning of the lens case, as well as the lenses, was shown to be particularly important.”

Seeks Better Labeling

Because of this, the FDA said that it is also asking manufacturers to expand labeling about proper lens care and lens case cleaning.

Overall, the study said, the risk of ulcerative keratitis for those who wore extended-wear lenses was 20 per 10,000 users per year, compared to four per 10,000 for daily lens users. Further, the study said, users of daily wear lenses had nine times the usual risk of developing the condition if they left the lenses in overnight. Smokers also were at additional risk, the study added.

Irving J. Arons, an optical industry specialist for the international consulting firm of Arthur D. Little Inc., said that he believes the actual incidence of corneal lesions “is still very small.”

‘Problem Overstated’

He added, “I think the problem has been overstated, and I think people are caring for their lenses better today.”

He predicted, however, that the study would provide “an impetus” for the new disposable lenses “that can be worn for one or two weeks and just thrown away, and a fresh lens put in place.”

Arons said that an estimated 24 million Americans wear contact lenses, of whom more than 19 million wear either conventional daily wear soft lenses or extended-wear soft lenses.

Extended-wear lenses were first approved by the FDA in 1981. The first reports of complications with their use began in late 1985.