含有亚麻籽油的人造撕裂,用于治疗干眼症:一项随机对照试验。
摘要来源:
ocul surf。 2019年11月14日。epub 2019 11月14日。pmid: 31734510“> 31734510”> 31734510 Berdy,Sherif El-Harazi,Anthony Verachtert,Jacqueline Tan,Haixia Liu,Cindy Carlisle-Wilcox,Peter Simmons,Joseph wearige
文章隶属关系:laura e downie
abfacte 摘要:
METHODS: 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或ROA 90天(每天灌输2次)。评估了眼表面疾病指数(OSDI;从第90天的基线开始的主要终点变化),泪膜破裂时间(TBUT)和眼染(联合/角膜/角膜/结合);在每个时间点计算这些参数中的基线的变化。每次访问时评估与治疗相关的不良事件(AE)。
结果: 总体而言,242个受试者是随机的(OM3,n = 120; roa,n = 122)。在第90天,在两个治疗组中,OSDI,眼部染色和TBUT的显着改善都显而易见。有利于O的团体间差异(P <0.05)观察到M3的眼染(所有时间点),角膜染色(第90天)和结膜染色(第30天)。与治疗相关的AE在ROA(9.8%)中较高(6.7%)组; blurred vision was among the most commonly reported AE (OM3 0% vs ROA 4.1%).
CONCLUSION: 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疾病。