Contact Lens Care & Compliance

2014 Contact Lens Microbiology Workshop

BY SUSAN J. GROMACKI, OD, MS, FAAO

On Sept. 12, 2014, the U.S. Food and Drug Administration (FDA) co-sponsored a workshop with the American Academy of Ophthalmology, the American Academy of Optometry, the American Optometric Association, and the Contact Lens Association of Ophthalmologists. According to FDA Press Officer Jennifer Rodriguez, the goal was to bring together “anyone [who] would be affected by the issue or by FDA’s actions ... people who use the products, manufacturers, health care providers, researchers, third-party payers, and the FDA or other sectors of the federal government” (Rodriguez, July 2014).

Panel 1: Emerging Pathogens in Contact Lens-Related Keratitis

Presentations included: “Causes of Contact Lens-Related Infectious Keratitis in the U.S.: Historical Trends and Emerging Pathogens” – Jennifer Cope, MD, MPH; “International Patterns of Contact Lens-Related Infectious Keratitis” – John Dart, MD; and “Impact of Changing Water Restrictions on Contact Lens-Related Infectious Keratitis” – Elmer Tu, MD.

The latter presentation pointed out that, although lens wear is the primary risk factor for Acanthamoeba keratitis (AK), domestic water quality has been linked to every large historical outbreak of the disease. In addition, the outbreak of AK from 2005 to 2007 was highly associated with Complete MoisturePlus (Advanced, now Abbott Medical Optics); however, after the solution was removed from the market, AK incidence rates remained virtually unchanged. “Current (contact lens) disinfection methods and practices have been inadequate to return the risk of developing Acanthamoeba keratitis to (the) previous baseline,” said Dr. Tu.

Panel 2: Role of Soil in Disinfection Efficacy Testing

Presentations included: “Definition of Organic Soil and the Relevant Components of an Artificial Tear Model” – Mark Willcox, PhD; “Incorporating Soil in the Preclinical Testing of Contact Lenses and their Products: Historical Perspective & Current Methods” – Scott Steffen, PhD; and “Measuring the Efficacy of Organic Soil Removal” – Joseph Hutter, PhD, and J. Angelo Green, PhD.

Panel 3: Acanthamoeba: The Organism and Test Methods

Presentations included: “Acanthamoeba keratitis: Biology of the Organism and Host Factors” – Donald Ahern, PhD; “Disinfection Efficacy Test Methods for Acanthamoeba, Part 1” – Daniel Fedorko, PhD; and “Part 2” – Simon Kilvington, PhD.

Questions and Conclusions

After each series of presentations, the FDA sought the panelists’ counsel on all of the above-mentioned topics. Three out of their five “panel questions” addressed very specific methods and criteria for testing lens care products against Acanthamoeba. Note: the protozoan is not currently one of the pathogens that the FDA utilizes to determine the efficacy of a lens care solution or care system.

As for any conclusions or potential changes in protocol that the FDA has made as a result of the meeting, Ms. Rodriguez states that the FDA is planning to write a paper this year summarizing the consensus points and results of the workshop. She reports: “We are considering the information obtained both from the May 2014 Ophthalmic Advisory Panel Meeting and this workshop as we consider any potential updates or revisions to our guidance documents (1994, 1997) for daily wear contact lenses and their accessories” (Rodriguez, Sept. 2014). CLS

For references, please visit www.clspectrum.com/references and click on document #228.

Dr. Gromacki is a diplomate in the American Academy of Optometry’s Section on Cornea, Contact Lenses and Refractive Technologies and practices in Chevy Chase, Md.