Lifitegrast ophthalmic solution 5.0% (KH732) for dry eye disease: A randomized, multicenter, double-masked, vehicle-controlled phase 3 trial
Abstract
BACKGROUND
Dry eye disease (DED) commonly impairs quality of life. This phase 3, randomized, double-masked, multicenter, vehicle-controlled trial evaluated the efficacy of 5.0% lifitegrast ophthalmic solution (KH732) in improving signs and symptoms of DED.
METHODS
Adults with moderate-to-severe DED and corneal staining score ≥2.0 in any corneal region were randomized 1:1 to lifitegrast (KH732) or vehicle twice daily for 84 days after a 3-7-day vehicle washout. The primary endpoint was change from baseline in inferior corneal staining score (ICSS) at Day 84. Secondary endpoints included changes in total corneal staining score, Eye Dryness Score (EDS), Ocular Surface Disease Index (OSDI), 7-item visual analogue scale, and Ocular Discomfort Score.
RESULTS
At Day 84, lifitegrast (n = 309) significantly reduced ICSS versus vehicle (n = 306) (P = 0.027). In a post hoc analysis, the effect was more pronounced in participants with the highest baseline staining in the inferior region (P = 0.046). Lifitegrast also significantly improved EDS (adjusted P = 0.006), ocular discomfort (adjusted P = 0.010), photophobia (adjusted P = 0.004), and OSDI (adjusted P = 0.014) versus vehicle. Post hoc analyses showed significant between-group differences in EDS, photophobia, and OSDI as early as Day 14. No serious ocular adverse events were reported.
CONCLUSIONS
Lifitegrast (KH732) improved both signs and symptoms of DED and was generally well tolerated, with potentially greater benefit in…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 309 participants or records.
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