Abstract
Abstract: :
Purpose: This analysis reports on the annual incidence of corneal inflammatory events as a function of extended wearing schedule from multi-center randomized clinical trials of lotrafilcon A lenses. Methods: : In two separate clinical trials, 658 subjects were randomized and dispensed lenses for 30 nights of continuous wear and 305 subjects were randomized and dispensed lenses for 6 nights of extended wear (lotrafilcon A lenses, CIBA Vision Corporation). Additional data from smaller trials with other wearing schedules (daily wear included) will also be reported. During the year-long trials subjects were examined during 7 scheduled follow-up visits and any required unscheduled visits. Endpoint corneal inflammatory infiltrative events were defined as corneal infiltrates of > grade 3 or infiltrates of any grade with overlying fluorescein staining. Analysis was conducted on a per subject basis as a percent of subjects dispensed. Results: The annual incidence of endpoint infiltrative events ranged from 3.4% to 5.0% for the extended wear modalities, with no significant differences between wearing times (Pearson’s Chi-Square, p=0.28). The incidence was lower in the daily wear studies. The relative influence of wearing time on the rate of events will be compared to other known risk factors for inflammatory events. Conclusions: Patient factors should be considered in selection of wearing schedule for silicone hydrogel lenses.