A clinical evaluation of lifitegrast ophthalmic solution 5% in symptomatic contact lens wearers

Abstract

Purpose: To evaluate the effectiveness of lifitegrast ophthalmic solution 5% in alleviating end-of-day dryness and discomfort in symptomatic contact lens (CL) wearers. Patients and Methods: This was an open-label study in symptomatic CL wearers with ratings of ≥ 40 for end-of-day dryness on a visual analog scale (VAS; 0– 100 scale; 100 worst). Participants wore their habitual CLs and instilled lifitegrast twice daily for 12 weeks with lenses removed. The performance of lifitegrast was assessed by comparing VAS 0– 100 ratings (100=worst) at 2, 6 and 12 weeks for end-of-day dryness and discomfort and Contact Lens Dry Eye Questionnaire-8 (CEQ-8) scores to baseline levels. Tear samples were collected at all visits to measure 10 different tear cytokines. Results: Forty participants (33F, mean age 30.8± 12.1 years, 65% daily disposable CL users) completed the study. There were no serious adverse events. Median (range) visual analog scale ratings for end-of-day dryness (Baseline: 76 (19– 99); 2-weeks: 43 (0– 95); 6-weeks: 26 (0– 94); 12-weeks: 15 (0– 98)) and discomfort (Baseline: 70 (10– 97); 2-weeks: 45 (0– 95); 6-weeks: 25 (0– 84); 12-weeks 11 (0– 96)) both significantly improved over time (all p< 0.01). At baseline, 100% of participants rated dryness ≥ 40, which dropped to 17% at 12 weeks. Baseline CLDEQ-8 scores of 22 (12– 31) had significantly decreased to 11 (1– 26) at 12 weeks. Comfortable CL wear time increased significantly from 6± 2 hours at baseline to 9± 3 hours at 6 and 12 weeks (all p< 0.01). Cytokine levels did not change over time. Conclusion: Lifitegrast significantly improved end-of-day dryness, end-of-day discomfort, CLDEQ-8 scores and comfortable CL wear time within 2 weeks of use.