%0 Journal Article
%T Safety and tolerability of lifitegrast ophthalmic solution 5.0%: Pooled analysis of five randomized controlled trials in dry eye disease
%A Amir Shojaei
%A Aparna Raychaudhuri
%A Eric D Donnenfeld
%A John A Hovanesian
%A Kelly K Nichols
%A Paul M Karpecki
%A Steven Zhang
%J European Journal of Ophthalmology
%@ 1724-6016
%D 2019
%R 10.1177/1120672118791936
%X Characterize the safety and tolerability of lifitegrast ophthalmic solution 5.0% for the treatment of dry eye disease. Pooled data from five randomized controlled trials were analyzed. Key inclusion criteria were adults with dry eye disease (Schirmer tear test score £¿1 and £¿10£¿mm, eye dryness score £¿40 (visual analog scale 0¨C100), corneal staining score £¿2.0 (0¨C4 scale)). Participants were randomized to lifitegrast ophthalmic solution 5.0% or placebo twice daily for 84 or 360£¿days. Treatment-emergent adverse events and drop comfort scores were assessed. Overall, 2464 participants (lifitegrast, n£¿=£¿1287; placebo, n£¿=£¿1177) were included. Ocular treatment-emergent adverse events occurring in >5% in either group were instillation site irritation (lifitegrast, 15.2%; placebo, 2.8%), instillation site reaction (lifitegrast, 12.3%; placebo, 2.3%), and instillation site pain (lifitegrast, 9.8%; placebo, 2.1%); the most common (>£¿5%) nonocular treatment-emergent adverse event was dysgeusia (lifitegrast, 14.5%; placebo, 0.3%). The majority of treatment-emergent adverse events were mild to moderate in severity. Discontinuation due to treatment-emergent adverse events occurred in 7.0% (lifitegrast) versus 2.6% (placebo) of participants (ocular: 5.5% vs 1.5%; nonocular: 1.9% vs 1.1%). Drop comfort scores with lifitegrast improved within 3£¿min of instillation and the score at 3£¿min improved across visits (12-week trials (both eyes, day 84 vs 0): 2.0 vs 3.3; SONATA (day 360 vs 0): right eye, 1.2 vs 1.7; left eye, 1.2 vs 1.8). Lifitegrast ophthalmic solution 5.0% appeared to be safe and well tolerated for the treatment of dry eye disease. Drop comfort with lifitegrast improved within 3£¿min of instillation
%K Adverse drug reactions
%K dry eye disease
%K lymphocyte function¨Cassociated antigen-1 antagonist
%K randomized controlled trial
%K safety
%U https://journals.sagepub.com/doi/full/10.1177/1120672118791936