Nichols Kelly K, Holland Edward, Toyos Melissa M, Peace James H, Majmudar Parag, Raychaudhuri Aparna, Hamdani Mohamed, Roy Monica, Shojaei Amir
School of Optometry, University of Alabama at Birmingham, Birmingham, AL.
Cincinnati Eye Institute, Edgewood, KY.
Clin Ophthalmol. 2018 Jan 31;12:263-270. doi: 10.2147/OPTH.S152841. eCollection 2018.
To evaluate ocular comfort of lifitegrast ophthalmic solution 5.0% among patients with dry eye disease (DED) in the OPUS-3 trial.
OPUS-3 was a multicenter, randomized, double-masked, placebo-controlled study. Adults with DED and recent artificial tear use were randomized 1:1 (lifitegrast:placebo) to ophthalmic drops twice daily for 84 days. On days 0 (baseline), 14, 42, and 84, drop comfort score (scale, 0-10; 0 = very comfortable, 10 = very uncomfortable) was measured at 0, 1, 2, and 3 minutes postinstillation. If the score was >3 at 3 minutes, assessment was repeated at 5, 10, and 15 minutes until score ≤3. Ocular treatment-emergent adverse events (TEAEs) were assessed.
Overall, 711 participants were randomized (n=357 received lifitegrast; n=354 received placebo). Drop comfort scores for lifitegrast-treated participants improved within 3 minutes of instillation (mean scores on day 84 for both study and fellow eyes: instillation: lifitegrast, 3.4, placebo, 1.0; 3 minutes: lifitegrast, 1.5, placebo, 0.7). The majority (64%-66%) of participants had scores <3 within 3 minutes postinstillation on days 14, 42, and 84. In participants with scores >3 at 3 minutes, the mean score in the lifitegrast group was similar to or better than that in the placebo group at 5, 10, or 15 minutes postinstillation. Lifitegrast appeared to be well tolerated, with ocular TEAEs rarely leading to discontinuation.
In OPUS-3, lifitegrast appeared to be well tolerated and drop comfort scores approached placebo levels by 3 minutes postinstillation.
在OPUS - 3试验中评估5.0%的lifitegrast眼药水对干眼症（DED）患者眼部舒适度的影响。
OPUS - 3是一项多中心、随机、双盲、安慰剂对照研究。近期使用过人工泪液的成年干眼症患者按1:1比例（lifitegrast：安慰剂）随机分组，每天滴眼两次，持续84天。在第0天（基线）、14天、42天和84天，于滴药后0、1、2和3分钟测量滴眼舒适度评分（范围0 - 10；0 = 非常舒适，10 = 非常不舒适）。如果3分钟时评分>3，则在5、10和15分钟重复评估，直至评分≤3。评估眼部治疗中出现的不良事件（TEAE）。
总体而言，711名参与者被随机分组（n = 357接受lifitegrast；n = 354接受安慰剂）。接受lifitegrast治疗的参与者滴眼舒适度评分在滴药后3分钟内有所改善（研究眼和对侧眼在第84天的平均评分：滴药时：lifitegrast为3.4，安慰剂为1.0；3分钟时：lifitegrast为1.5，安慰剂为0.7）。在第14天、42天和84天，大多数（64% - 66%）参与者在滴药后3分钟内评分<3。在3分钟时评分>3的参与者中，lifitegrast组在滴药后5、10或15分钟的平均评分与安慰剂组相似或更好。Lifitegrast似乎耐受性良好，眼部TEAE很少导致停药。
在OPUS - 3试验中，lifitegrast似乎耐受性良好，滴眼舒适度评分在滴药后3分钟接近安慰剂水平。
