FDA cautions practitioners against unapproved orthokeratology, tinted contact lenses

Issue: November 1998

ROCKVILLE, Md. - The Food and Drug Administration (FDA) has alerted practitioners about two unapproved contact lens uses.

The federal agency alerted practitioners that only two "theatrical" tinted contact lenses have been evaluated by the FDA for safety and effectiveness, and no orthokeratology (ortho-K) lenses have been approved for overnight wear.

Only two companies - Wesley Jessen, maker of WildEyes, and Finnish firm CL Tinters, maker of Crazy Lens - have received FDA approval to market tinted "theatrical" lenses, according to James F. Saviola, OD, FAAO, CDRH, branch chief in the FDA's Division of Ophthalmic Devices. The OK lens, from Contex Inc., of Sherman Oaks, Calif., is the only ortho-K lens to receive FDA approval, and it is approved only for daily wear.

Theatrical tinting addressed

The FDA notification letter addresses only theatrical tinted lenses that drastically alter the appearance of the eye. Visibility tints and opaque lenses that change the color of the eye are available as several FDA-approved products, Dr. Saviola said.

"The health notification was directed at concerns about companies that are marketing over the Internet and offering these specialty tinted lenses about which the FDA doesn't have much information," Dr. Saviola said. "The potential for some lack of biocompatibility is there because we didn't really know what these different companies were using to tint their lenses."

The FDA is concerned with the method used to tint the lens and the potential toxicity of the tint, Dr. Saviola said. Any tint or pigment used in coloring lenses must be determined to be safe for that application. Approved tints and pigments are listed in the Federal Register by the FDA's Center for Food Safety.

Tinting has been easy to obtain

It is been relatively easy for practitioners to have lenses tinted by companies that do not have FDA clearance, Dr. Saviola said. Industry listings of contact lenses, such as Tyler's Quarterly, include a number of firms under the headings "Prosthetic" or "Custom-tinted lenses." Doctors have been sending lenses to many of these firms to have them tinted and returned, he continued.

The notification letter is one of the lesser actions the FDA can take. The intention is to inform practitioners about practices that have not been approved and to help the FDA obtain more information about the product or practice, especially reports of injuries.

"If we find that we do get a lot of reports or complaints regarding certain lenses, we may take additional action, but we didn't have a lot of information to go on," Dr. Saviola said. "Due to the large number (15 to 20) of firms advertising in professional journals and trade publications and over the Internet, it was difficult to take a compliance action at this point given the resources available to the FDA and the lack of data concerning problems."

An Internet search conducted by Primary Care Optometry News located several companies marketing "custom-tinted" or "special effects" contact lenses. The web sites were aimed at consumers, not practitioners, though most required consumers to obtain their contact lens prescription from a doctor then send it to the company. A few companies required the contact lens order to come directly from an eye care practitioner, and the lenses would be delivered to the practitioner's office. Other companies recommend seeing an eye care provider for fitting instructions, especially for first-time contact lens wearers. Two companies - not Wesley Jessen or CL Tinters - claimed they used FDA-approved methods or dyes.

Practitioners who are unsure of the safety of a specific tint or tinting process can ask the company to supply the complete copy of the product labeling. This will include not only the label that goes on the vial or blister pack, but also the package inserts, the practitioner fitting guide and the patient information booklet, Dr. Saviola added.

Level playing field for ortho-K

Ortho-K has been practiced in the United States for more than 30 years, but until this year when Contex received FDA approval, marketing was similar among most companies who manufactured the lenses, Dr. Saviola said.

"Now that we have a manufacturer who has gone through the approval process, it really is incumbent upon us to maintain a level playing field and to not have the other firms marketing devices without legal authorization," he said.

As is the case with the tinted lenses, the notification letter is intended as a precautionary measure and a way for the FDA to cull more information regarding overnight ortho-K wear.

"The FDA has no significant information regarding actual injury with these lenses, but there is the potential for injury," Dr. Saviola said. "We're hoping to receive some reports under the MedWatch system and spur the firms that are really out of compliance to take some action and work with us to become compliant."

Several companies are promoting ortho-K lenses for overnight wear, primarily in ortho-K trade publications, and the FDA is working with these companies on a "cooperative" basis to get them to begin clinical studies regarding the safety and efficacy of overnight wear, he said. Without specific reports of injury that might have been caused by a particular lens, the agency opted for a cautionary approach.

"Without having that demonstrated health risk, our inclination to take a particular action isn't as great as if there was a demonstrated health risk," Dr. Saviola said.

Some ortho-K practitioners have argued that if the lens material is approved for extended wear, they should be able to use that material for overnight wear, said Rodger Kame, OD, FAAO, in practice in Los Angeles. Dr. Kame feels reverse geometry lens designs need verification and validation studies for overnight wear safety.

No exaggerated claims allowed

In the notification letter, the FDA explains that practitioners can design and prescribe rigid gas-permeable (RGP) ortho-K lenses within their practice, but those who promote ortho-K should not make exaggerated claims. Practitioners also should explain to the patients that the effect of the lenses is temporary and limited.

While increased risk exists with over night wear of any lens, RGP lenses minimize that risk, Dr. Kame said. "It has been shown that overnight wear increases risk of infection considerably," he said. "It has also been shown that RGP lenses reduce the incidence of complications because so much more oxygen reaches the cornea, and RGP lenses create less propensity of the epithelial cells to adhere bacteria."

The International Orthokeratology Section of the National Eye Research Foundation (IOS/NERF) agrees with the FDA and the Federal Trade Commission that ortho-K is a procedure, not a lens, and has raised several questions with the FDA regarding the notification letter.

IOS/NERF questions why the FDA sent a notification letter to practitioners instead of manufacturers, considering the agency regulates lens manufacturing, not the practice of medicine. The organization has submitted an article by Stuart Grant, OD, FAAO, published in the November 1992 issue of Contact Lens Spectrum titled "Orthokeratology - Night therapy and night retention" to help answer the FDA's questions regarding the lack of well-controlled studies published in the literature on night wear of ortho-K lenses. IOS/NERF also requested a summary of reported adverse effects related to RGP lenses from the FDA in order to direct research and educational efforts to avoid future problems, according to John M. Rinehart, OD, FIOS, chairman of IOS/NERF.

At least two companies are developing ortho-K lenses for overnight wear. Euclid Systems Corp., of Herndon, Va., has received an Investigational Device Exemption (IDE) from the FDA to conduct a clinical trial of its orthokeratology lens. SciOptic, of Ossining, N.Y., applied for an IDE for its Eccentricity Zero Molding lens earlier this year and has hired a consultant who has experience with the FDA approval process to help the company complete the application process, according to company owner and president David Amaris.

Dr. Saviola said the FDA is working with other companies that plan to develop ortho-K lenses for overnight wear and are preparing to conduct investigational studies, but he could not disclose the names of those companies.

For Your Information:
David Amaris, president and owner of SciOptic, 238 N. Highland Ave., Ossining, NY 10562; (800) 462-7560; fax: (800) 641-8273. Rodger Kame, OD, FAAO, ay be contacted at 250 E. First St., Ste. 802, Los Angeles, CA 90012-3875; (213) 628-7419; fax: (213) 620-9110. Dr. Kame has no direct financial interest in the products mentioned in this article, nor is he a paid consultant for any companies mentioned.

James F. Saviola, OD, FAAO, CDRH, can be contacted at the Office of Device Evaluation, HFZ-460, 9200 Corporate Blvd., Rockville, MD 20850; (301) 594-1744; fax: (301) 480-4201. Dr. Saviola has no direct financial interest in the products mentioned in this article.

The International Orthokeratology Section of the National Eye Research Foundation can be contacted at 910 Skokie Blvd., Suite 207A, Northbrook, IL 60062; (847) 564-4652; (800) 621-2258; fax: (847) 564-0807.
The notification can be found in its entirety on the FDA web site at www.fda.gov/cdrh/safet.html. To report an adverse event to the FDA, phone (800) FDA-1088; fax (800) FDA-0178; or mail MedWatch, Food and Drug Administration, 5600 Fishers Lane, HF-2, Rockville, MD 20850.