Q:  Most of my colleagues have resumed telling patients to rub and rinse lenses, despite the popularity of no-rub multipurpose solutions. Do the FDA or manufacturers have recommendations regarding the use of multipurpose solutions and silicone hydrogel lenses?

A: Neither the FDA nor the manufacturers have much to add to this debatefor now. But, the whole to-rub-or-not-to-rub controversy is very much on everyones minds these days, chiefly because of the Fusarium keratitis outbreak that occurred last year. One-third of the Fusarium keratitis patients identified by the Centers for Disease Control and Prevention (CDC) required corneal transplants. The outbreak served as a vivid reminder of the importance of lens care regimens.

To make matters worse, Acanthamoeba keratitis (AK) appears to be staging a comeback. A study in the August 2006 issue of the American Journal of Ophthalmology concluded that AK cases in contact lens wearers are increasing in frequency.1 Anecdotal reports seem to confirm this trend.

In a sense, the rub-or-not-to-rub conundrum is indicative of an industry in transition. Silicone hydrogel lenses have proven themselves everything we had hoped, providing increased late-day comfort, better oxygen transmission and relief of dryness. Lens care products have yet to catch up to this advancement, however. Most no-rub solutions on the market today were tested on conventional hydrogels, and researchers are finding that silicone hydrogel lens materials may be somewhat less compatible with certain solutions.

In response to this situation and at the urging of practitioners, the FDA is considering a new lens material classification that will consider the unique properties of silicone hydrogel lenses. According to James F. Saviola, O.D., chief of the vitreoretinal and extraocular devices branch at the FDAs Center for Devices and Radiological Health, the FDA has been studying this issue since last August.

The driving force for advocating new groups for silicone hydrogels initiated from medical professionals using these new materials and identifying solution incompatibilities, Dr. Saviola says. Solution incompatibilities with these new lenses were difficult to predict without testing each lens and each solution on a case-by-case basis, creating an enormous burden on the industry.

Re-classification efforts are ongoing, and Dr. Saviola could not predict when results would be made public. New materials classifications could impact the no-rub debate. As we are better able to characterize the differences between hydrogels and silicone hydrogels, well have more information about how important it is to have a rubbing step, he says.

Silicone hydrogels are more prone to lipid deposits than conventional hydrogels, and many O.D.s feel a rubbing step is necessary to remove lipids. But, no one is sure what other risks the newer lens materials might pose, so doctors frequently opt to play it safe.

The Fusarium thing has really changed everything, says Christine W. Sindt, O.D., of the University of Iowas Department of Ophthalmology and Visual Sciences. A frequent lecturer on contact lens care, Dr. Sindt routinely polls her audiences on how many require patients to rub their lenses. About one-third did before the Fusarium outbreak, she says, but now almost all her audience members say they ask patients to rub.

Dr. Sindt herself always stresses the importance of a rubbing step to her patients. Doctors are moving away from [no-rub solutions], and the industry will follow, she says. No-rub solutions may continue to be available, but its going to become the tiny print on the bottle, she adds.

In fact, no-rub is not promoted and marketed as aggressively as it once was. The print and graphics on solution bottles advertising no-rub qualities have grown noticeably smaller over the years. Some feel manufacturers should stop promoting the concept altogether.

Indeed, a persistent rumor has circulated that Bausch & Lomb would cease promoting no-rub before this years end. The company, however, denies this. Given the fact that we have both a rub and no-rub regimen indication from the FDA, Bausch & Lomb does not intend to back away from either indication, says Jeff Nardoci, vice president of marketing for OTC products.

Another way to look at this is from a safety standpoint. Patients dont follow our instructions, says Kenneth A. Lebow, O.D., of Virginia Beach, Va. If we havent figured that out yet, theres something wrong with us. A no-rub solution means it has passed the FDA stand-alone requirement, and that means the solution is more efficacious at killing bacteria. This means greater safety for my patients and greater comfort for me.

Dr. Lebow recommends no-rub solutions for his patients. But, unless the lenses demonstrate deposits or other problems, he does not ask patients to rub their lenses, assuming they will probably ignore his advice anyway.

 

1. Joslin CE, Tu EY, McMahon TT, et al. Epidemiological characteristics of a Chicago-area Acanthamoeba keratitis outbreak. Am J Ophthalmol 2006 Aug;142(2):212-7.