Nichols Kelly K, Donnenfeld Eric D, Karpecki Paul M, Hovanesian John A, Raychaudhuri Aparna, Shojaei Amir, Zhang Steven
1 School of Optometry, The University of Alabama at Birmingham, Birmingham, AL, USA.
2 Ophthalmic Consultants of Long Island, Garden City, NY, USA.
Eur J Ophthalmol. 2019 Jul;29(4):394-401. doi: 10.1177/1120672118791936. Epub 2018 Aug 16.
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 0-100), corneal staining score ⩾2.0 (0-4 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.
评估5.0%的lifitegrast眼药水治疗干眼症的安全性和耐受性。
分析来自五项随机对照试验的汇总数据。主要纳入标准为患有干眼症的成年人（泪液分泌试验评分≥1且≤10毫米，眼干评分≥40（视觉模拟评分0-100），角膜染色评分≥2.0（0-4分））。参与者被随机分为每日两次使用5.0%的lifitegrast眼药水或安慰剂，持续84或360天。评估治疗期间出现的不良事件和滴眼液舒适度评分。
总体而言，共纳入2464名参与者（lifitegrast组，n = 1287；安慰剂组，n = 1177）。两组中发生率超过5%的眼部治疗期间出现的不良事件为滴眼部位刺激（lifitegrast组，15.2%；安慰剂组，2.8%）、滴眼部位反应（lifitegrast组，12.3%；安慰剂组，2.3%）和滴眼部位疼痛（lifitegrast组，9.8%；安慰剂组，2.1%）；最常见的（>5%）非眼部治疗期间出现的不良事件是味觉障碍（lifitegrast组，14.5%；安慰剂组，0.3%）。大多数治疗期间出现的不良事件为轻至中度。因治疗期间出现的不良事件而停药的参与者比例在lifitegrast组为7.0%，在安慰剂组为2.6%（眼部：5.5%对1.5%；非眼部：1.9%对1.1%）。使用lifitegrast后，滴眼液舒适度在滴入后3分钟内有所改善，且在各次访视中3分钟时的评分均有所提高（12周试验（双眼，第84天对第0天）：2.0对3.3；SONATA试验（第360天对第0天）：右眼，1.2对1.7；左眼，1.2对1.8）。
5.0%的lifitegrast眼药水在治疗干眼症方面似乎安全且耐受性良好。使用lifitegrast后，滴眼液舒适度在滴入后3分钟内得到改善。
