Draft Questions for Panel Discussion

Note to Panel Members:

These are Draft Questions. The actual questions to be asked during the panel meeting may be different. Please be prepared to discuss the following issues. Panel discussions provide FDA with expert knowledge and experience on issues and safety and effectiveness questions. FDA values an open debate raising new ideas and perspectives.

Labeling/Human Factors

1. Please discuss any recommendations for modifications to patient labeling for contact lens care products and contact lenses or recommendations for modifying the contact lens website. Please include the following topics in your discussion:

a. Patient reuse or "topping-off" of solution left in the lens case.

b. Describing the recommended rubbing and rinsing times to used in the pre-clinical testing to disinfect contact lenses.

c. Rinsing the lens case with sterile contact lens solution as opposed to water

d. The use of a “discard” date on the lens care products labeling (based on standard tests) in addition to an expiration date.

e. Recommending replacing the lens case frequently, such as every three months.

f. Conveying the risk of eye infection involving water activities (e.g., showering, swimming).

g. Labeling contact lens care products with specific contact lens types such as conventional hydrogel or silicone-hydrogel.

2. Please discuss any recommendations for Agency outreach projects with care providers and/or consumers to improve patient compliance, emphasize quick patient response to lens related symptoms, prompt diagnosis by the care providers.

Clinical

3. Please discuss any recommendations for evaluating corneal staining in determining contact lens care product safety and effectiveness. Please include the following topics in your discussion:

a. The role of transient corneal staining, noted with some combinations of contact lenses and contact lens care products, as a risk factor for microbial keratitis.

b. Including silicone-hydrogel lenses in clinical testing in the absence of silicone-hydrogel contact lenses of sub-groupings.

Microbiology

4. Please discus any recommendations concerning “no rub”/ “rubbing” directions for use in the care and disinfection of contact lenses.

5. Please discuss any recommendations on revising the preclinical microbiology test methods to serve as better predictors of ‘real world’ product performance. Please include the following topics in your discussion:

a. Assessing Acanthamoeba in disinfection efficacy testing or characterizing that organism’s response when exposed to a contact lens care product.

b. Including silicone hydrogel lenses in microbiology tests.

c. Evaluating lens care products effectiveness in the presence of contact lenses to characterize any interactions, and to establish recommended post-disinfection lens storage times.

d. Quantifying the amount of preservative depletion by absorption into a contact lens during the disinfection efficacy testing.

e. Conducting microbiology effectiveness tests using ‘worst case’ condition of care product at lowest concentration of active ingredient specification.

Biocompatibility

6. Please discuss any recommendations on the preclinical biocompatibility testing for a new Multipurpose Solution (MPS) and address conducting these tests with both conventional hydrogel as well as silicone-hydrogel contact lenses.

Chemistry

7. Please discuss any recommendations on silicone-hydrogel lens groupings with regard to differentiating lens characteristics and predicting lens care product interactions. Please address the urgency for developing subcategories to evaluate these lenses.