Over the past two years, several popular contact lens solutions have been linked to cases of serious eye infections. The most recent case involved Advanced Medical Optical’s Complete® MoisturePlus(TM) solution, which was recalled in May of 2007, as it was linked to cases of Acanthamoeba keratitis, an inflammation caused by a parasite. With the link between infections and contact lens solutions established, eye care professionals are examining the existing regulations of the Food and Drug Administration (FDA). The Complete MoisturePlus solution was not contaminated, but was found to be ineffective at preventing the infection. The Centers for Disease Control (CDC) found that contact lens wearers were 17 times more likely to contract Acanthamoeba keratitis if they used Complete MoisturePlus than other multi-purpose solutions.
Acanthamoeba are microscopic one-celled organisms that occur naturally in water sources such as tap water, well water, and hot tubs. Acanthamoeba are parasites capable of thriving in the neutral pH environment of the eye. If the eye becomes infected with Acanthamoeba, Acanthamoeba keratitis results. The infection is rare, but can be severe and painful, often causing corneal scarring and sometimes blindness. Acanthamoeba keratitis symptoms include redness and eye pain after lens removal, as well as tearing, light sensitivity, and blurred vision. Because the symptoms are similar to those of other infections, Acanthamoeba keratitis can be very difficult to diagnose and treat. Some rare cases may even require a corneal transplant as treatment. To avoid contracting the infection, it is important that contact lens wearers: · Follow the recommendations of their eye care practitioner regarding contact lens products and care. · Never use tap water to rinse or clean lenses or cases. Use only sterile solutions. · Do not wear contact lenses while swimming, showering or in a hot tub without airtight goggles. · Soak lenses in fresh disinfecting solution every night, never top off solution in lens case, and do not use homemade solutions. · Wash hands before handling lenses. · Keep lens case clean and dry when not storing lenses. · Clean lenses upon removal and rub lenses with multi-purpose solution. Not all solutions have the same ability to disinfect, so be sure to speak to an eye care practitioner before making any changes. It is important that all contact lens wearers keep in mind that contacts are a medical device, and improper care of their lenses can result in painful infections or other impairments. Wearers must be diligent about keeping their contact lenses and case clean, and replace cases at least once every three months. Be sure to only use sterile solutions recommended by an eye care professional.
In response to the recall of AMO’s Complete Moisture Plus solution, a panel of experts recommended that the FDA impose stricter guidelines for testing and labeling contact lens solutions. The American Optometric Association suggested the FDA strengthen its testing of products before introducing them into the market. “We feel that a more standardized testing process should be developed and used by the FDA, prior to approval, as well as to compare efficacy between products so that a practitioner can make better judgments when prescribing solutions,” Dr. Louise A. Sclafani, chair of the American Optometric Association (AOA) Contact Lens and Cornea Section, said in a presentation to the FDA. Some AOA recommendations included testing under no-rub and no-rinse conditions and testing with actual lens and case materials. A study by the University of Manchester in the United Kingdom found that most contact lens wearers do not wash their hands before inserting their lenses, and are less likely to do so when removing them. Another study found that risk for infection increases by four times when wearers do not properly clean their cases. The AOA also suggested that tests be performed with dirty hands and dirty cases. The FDA regulates contact lenses through the Federal Food, Drug and Cosmetic Act. The active guidance document relevant to contact lens products was drafted in 1997. The AOA recommends updates to labeling to include a mandatory discard date. Labels should also include, in a prominent, large font, disclaimers such as ‘Wash hands before handling lenses or products,’ ‘Do not top off solution,’ and ‘Rub and rinse is necessary,’ the AOA argued. The FDA has not yet made any changes or updates to their regulations regarding contact lenses and contact lens products. More information on eye health and contact lenses can be found at our web.