BUSINESS WIRE
Improving contact lens product testing and advocating universal lens care guidelines for consumers will improve contact lens safety, according to key recommendations presented to the U.S. Food and Drug Administration (FDA) today by a coalition of ophthalmic organizations. The American Academy of Ophthalmology (Academy), the Contact Lens Association of Ophthalmologists (CLAO), the Cornea Society and the American Society of Cataract and Refractive Surgery (ASCRS) urged the changes as experts report that the number of cases of microbial keratitis, particularly Acanthamoeba keratitis, among contact lens wearers remain steady, despite attempts to improve contact lens disinfection regimens over the years and voluntary recalls of contact lens solutions associated with keratitis outbreaks in 2006 and 2007.
“Now is the time to tighten the safety net around contact lens products,” said Elmer Tu, MD, Academy spokesperson and director of the cornea and external disease service at the University of Illinois at Chicago. “While improved testing and consumer awareness of lens care guidelines may not prevent future outbreaks of eye infections, they will provide an important additional layer of safety for contact lens wearers.”
In remarks to the FDA today, the organizations recommend that the FDA work closely with industry to expand and strengthen contact lens solution and product testing to better protect consumers. Key recommendations include:
Contact lens solution testing should be updated to ensure products are
effective against a more diverse and representative set of infectious
organisms, including Acanthamoeba.
A standardized and validated testing protocol should be adopted to
ensure all contact lens products are meeting the same demands.
Contact lens solution testing should be made more rigorous to include
standardized “real-world”
scenarios, such as effectiveness while in a contact lens case and
effectiveness when solution evaporates.
Given the complexity of contact lens solutions and the environment
within which they are expected to work, the FDA should re-examine the
concept of equivalency testing—the practice
of determining if new products are substantially similar to existing
approved products—when a revised formula is
submitted. Each product should be evaluated on its own.
Dr. Tu also noted in his testimony that research shows that the disinfection regimen appears to be but one element for an increased risk of infection. “The exact factor or combination of factors that has led to the outbreaks of keratitis remain unclear,” he said. Other factors, such as use of extended wear lenses, reduced tear exchange under the lens with current designs, environmental factors and poor consumer hygiene, are likely of equal or greater importance and deserve additional research too.
Because infections like Acanthamoeba keratitis and Fusarium keratitis are not typically tracked by federal health authorities, the organizations also recommended that the FDA consider the feasibility of developing a mechanism for monitoring contact lens infections and the frequency and distribution of the organisms causing those infections.
Contact Lens Care Guidelines
The organizations also outlined the important steps consumers should take to safeguard against eye infections. While variations of care guidelines exist, the recommendations presented were uniformly agreed upon by the Academy, CLAO, the Cornea Society and ASCRS.
“The single best way to avoid eye infections is to follow proper lens care guidelines as prescribed by your eye care professional,” said William Ehlers, MD, a corneal specialist at the University of Connecticut Health Center and immediate past president of CLAO.
Among the key care guidelines contact lens followers should follow:
- Before handling contact lenses, wash your hands with soap and water, then rinse and dry them with a lint-free towel.
- Minimize contact with water, including removing lenses before going swimming or in a hot tub.
- Contact lenses should not be rinsed with or stored in water (tap or sterile water).
- During cleaning, rub your contact lenses with your fingers, then rinse the lenses with solution before soaking them. This “rub and rinse” method is considered by some experts to be a superior method of cleaning, even if the solution you are using is a “no-rub” variety.
- Rinse the contact lens case with fresh solution — not water. Then leave the empty case open to air dry.
- Keep the contact lens case clean and replace it regularly, at least every three months. Lens cases can be a source of contamination and infection. Do not use cracked or damaged lens cases.
- Handle your contact lens solution with care:
- Do not re-use old solution or "top off" the solution in your lens case.
- Do not transfer contact lens solution into smaller travel-size containers. This can affect the sterility of the solution, which can lead to an eye infection.
- Do not allow the tip of the solution bottle to come in contact with any surface, and keep the bottle tightly closed when not in use.
Cornea Society spokesperson Elisabeth Cohen, MD, added, “Water may carry organisms, including Acanthamoeba, fungi and bacteria, that can cause eye infections. Contacts lenses and water do not mix, and lens wearers should avoid lens contact with water.”
In his testimony today, Dr. Ehlers added that contact lens wearers should be examined by an eye care provider annually, and more often as needed. These regular exams are important opportunities for making necessary updates to prescriptions, checking overall eye health and reinforcing proper lens care.
Ophthalmologists remain concerned about the practice of “passive verification” of contact lens prescriptions. Under this system, third-party sellers (such as online vendors) of contact lenses notify eye care professionals of customer requests to purchase contact lenses. Unless the eye care professional affirmatively notifies the seller within eight business hours that the prescription is incorrect, expired or otherwise problematic, the seller may presume that the prescription is correct and valid and complete the sale. Passive verification may lead to the fulfillment of an expired prescription and may extend the period between eye exams, which can increase the risk to patients’ eye health.
Contact lens wearers who experience eye infection symptoms like redness, pain, excessive tearing, increased light sensitivity, blurry vision, discharge or swelling should immediately see their ophthalmologist.
For a complete list of all the recommendations made to the FDA about pre-clinical product testing and consumer lens care guidelines, please go to www.aao.org or www.geteyesmart.org.
Note to broadcast stations: B-roll is available on proper contact lens cleaning techniques. Please contact Dan Schwartzberg of News Broadcast Network at 212-684-8910 to download the footage electronically.
About the American Academy of Ophthalmology
The American Academy of Ophthalmology is the world’s largest association of eye physicians and surgeons—Eye M.D.s—with more than 27,000 members worldwide. Eye health care is provided by the three “O’s” – opticians, optometrists and ophthalmologists. It is the ophthalmologist, or Eye M.D., who can treat it all: eye diseases and injuries, and perform eye surgery. To find an Eye M.D. in your area, visit the Academy’s Web site at www.aao.org.
About the Contact Lens Association of Ophthalmologists
The Contact Lens Association of Ophthalmologists, Inc., (CLAO) was founded in 1963 and incorporated in 1964 as a not-for-profit association whose mission today is to advance quality medical eyecare for the public by providing comprehensive ophthalmologists and other eyecare professionals with education and training in contact lenses and related eyecare science. CLAO produces the peer-reviewed journal, Eye and Contact Lens: Science and Clinical Practice. For more information, please visit www.clao.org.
About the Cornea Society
The Cornea Society is an international society to promote knowledge, research and understanding in cornea, external disease and refractive surgery. For more information, please visit www.corneasociety.org.
About the American Society of Cataract and Refractive Surgery
The mission of the ASCRS is to advance the art and science of ophthalmic surgery and the knowledge and skills of ophthalmic surgeons. It does so by providing clinical and practice management education and by working with patients, government, and the medical community to promote the delivery of quality eye care. The society has 10,000 members worldwide. For more information, please visit www.corneasociety.org.