CLINICAL EXPERIENCE WITH A NEW REWETTING DROP SHOWN TO MINIMIZE PROTEIN DEPOSITION DURING SOFT CONTACT LENS WEAR

Jerry Stein

Abstract

PURPOSE. Contact lens wearers frequently experience discomfort and dryness symptoms and often use a rewetting drop for relief. It is believed that protein and other soilant deposition is a factor that contributes to these symptoms associated with contact lens wear. A rewetting drop that relieves these symptoms and minimizes deposits would provide a distinct advantage over drops that simply relieve symptoms. Several clinical studies evaluated the efficacy and safety of a new rewetting drop (Clerz Plus) used with soft (hydrophilic) and rigid gas permeable (RGP) lenses. METHOD. A total of 660 patients were enrolled in two-week to three-month studies conducted at 26 sites in the U.S. and Canada. Efficacy variables included lens cleanliness (investigator and laboratory evaluations), wear time, visual acuity, lens replacements, patient comfort/acceptability and interview results. Safety parameters included slit-lamp examinations, adverse event monitoring and product-related discontinuances.

RESULTS. Use of the drop resulted in significantly less laboratory-measured lysozyme on both daily wear (942 vs 1102 micrograms) and extended wear (804 vs 1084 micrograms) soft lenses as compared to another marketed rewetting drop (p< 0.01). Ninety percent or more of the soft lenses in each study were rated by investigators as clinically clean. Wear time and visual acuity were maintained consistent with baseline values. Unscheduled lens replacements were infrequent and generally unrelated to use of the rewetting drop. Patient comfort and acceptability were repeatedly demonstrated and expressions of patient satisfaction were common in exit interviews, often favoring the new drop over the control rewetting drop used in the study. The low incidence of slit-lamp findings and related adverse events were evidence of the safety of the rewetting drop.

CONCLUSIONS. The new rewetting drop has been developed and recently marketed. Use of this rewetting drop provides relief from discomfort and dryness symptoms experienced during soft and RGP contact lens wear and minimizes protein deposition on soft contact lenses.

Details

Year: 2001

Program Number: Poster 143

Author Affiliation: Alcon Research, Ltd.

Co-Authors: Mike Christensen, Ralph Stone, David Keith, Janey McGrath, Jacqueline Barry, Marion Tudor

Co-Author Affiliation: n/a

Room: Exhibit Hall C