Downie Laura E, Hom Milton M, Berdy Gregg J, El-Harazi Sherif, Verachtert Anthony, Tan Jacqueline, Liu Haixia, Carlisle-Wilcox Cindy, Simmons Peter, Vehige Joseph
Department of Optometry and Vision Sciences, University of Melbourne, Parkville, VIC, Australia.
Canyon City Eyecare, Azusa, CA, USA.
Ocul Surf. 2020 Jan;18(1):148-157. doi: 10.1016/j.jtos.2019.11.004. Epub 2019 Nov 14.
To evaluate the efficacy and safety of a nano-emulsion artificial tear (OM3) containing carboxymethylcellulose (CMC) and glycerin, flaxseed oil and castor oil, and three osmoprotectants (levocarnitine, erythritol, and trehalose) compared with an artificial tear (Refresh Optive Advanced [ROA]) containing the same ingredients with the exception of trehalose and flaxseed oil.
In this multicenter, double-masked, randomized, two-arm, parallel-group, 6-visit study (screening, baseline, and days 7, 30, 60, and 90), subjects with dry eye disease underwent an open-label, 7-day run-in with CMC 0.5% (Refresh Plus), before 1:1 randomization to OM3 or ROA for 90 days (both instilled ≥2 daily). Ocular Surface Disease Index (OSDI; primary endpoint change from baseline at day 90), tear film breakup time (TBUT), and ocular staining (combined/corneal/conjunctival) were assessed; change from baseline in these parameters was calculated at each timepoint. Treatment-related adverse events (AEs) were assessed at each visit.
Overall, 242 subjects were randomized (OM3, n = 120; ROA, n = 122). At day 90, significant improvements in OSDI, ocular staining and TBUT were evident in both treatment groups. Significant (P < 0.05) between-group differences in favor of OM3 were observed for combined ocular staining (all timepoints), corneal staining (day 90), and conjunctival staining (day 30). Treatment-related AEs were higher in the ROA (9.8%) versus OM3 (6.7%) group; blurred vision was among the most commonly reported AE (OM3 0% vs ROA 4.1%).
These findings support the application of OM3, a novel preservative-free, nano-emulsion tear formulation with trehalose and flaxseed oil, for the treatment of dry eye disease.
评估一种含有羧甲基纤维素（CMC）、甘油、亚麻籽油和蓖麻油以及三种渗透保护剂（左旋肉碱、赤藓糖醇和海藻糖）的纳米乳剂人工泪液（OM3）与一种除不含海藻糖和亚麻籽油外含有相同成分的人工泪液（Refresh Optive Advanced [ROA]）相比的疗效和安全性。
在这项多中心、双盲、随机、双臂、平行组、6次访视的研究（筛查、基线以及第7、30、60和90天）中，患有干眼症的受试者在接受0.5% CMC（Refresh Plus）的开放标签、为期7天的导入期后，按1:1随机分为OM3或ROA组，治疗90天（两者均每天滴眼≥2次）。评估眼表疾病指数（OSDI；主要终点为第90天相对于基线的变化）、泪膜破裂时间（TBUT）和眼部染色（综合/角膜/结膜）；在每个时间点计算这些参数相对于基线的变化。在每次访视时评估与治疗相关的不良事件（AE）。
总体而言，242名受试者被随机分组（OM3组，n = 120；ROA组，n = 122）。在第90天，两个治疗组的OSDI、眼部染色和TBUT均有显著改善。在综合眼部染色（所有时间点）、角膜染色（第90天）和结膜染色（第30天）方面，观察到有利于OM3组的显著组间差异（P < 0.05）。与治疗相关的AE在ROA组（9.8%）高于OM3组（6.7%）；视力模糊是最常报告的AE之一（OM3组为0%，ROA组为4.1%）。
这些发现支持将OM3（一种含有海藻糖和亚麻籽油的新型无防腐剂纳米乳剂泪液制剂）用于治疗干眼症。
