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An artificial tear containing flaxseed oil for treating dry eye disease: A randomized controlled trial.
The Ocular Surface ( IF 6.4 ) Pub Date : 2019-11-14 , DOI: 10.1016/j.jtos.2019.11.004
Laura E Downie 1 , Milton M Hom 2 , Gregg J Berdy 3 , Sherif El-Harazi 4 , Anthony Verachtert 5 , Jacqueline Tan 6 , Haixia Liu 7 , Cindy Carlisle-Wilcox 7 , Peter Simmons 8 , Joseph Vehige 7
Affiliation  

Purpose

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.

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 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.

Results

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%).

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 disease.



中文翻译:

一种含有亚麻籽油的人工泪液,用于治疗干眼症:一项随机对照试验。

目的

评估与羧甲基纤维素(CMC)和甘油,亚麻籽油和蓖麻油以及三种渗透保护剂(左肉碱,赤藓醇和海藻糖)相比的纳米乳剂人工泪液(OM3)与人工泪液(Refresh Optive Advanced)的有效性和安全性[ROA])含有相同的成分,但海藻糖和亚麻籽油除外。

方法

在这项多中心,双掩蔽,随机,双臂,平行组,6次研究(筛查,基线以及第7、30、60和90天)中,患有干眼病的受试者接受了开放标签,用0.5%CMC(Refresh Plus)进行7天磨合,然后将1:1随机分配给OM3或ROA,共90天(每天滴注≥2次)。评估了眼表疾病指数(OSDI;第90天时相对于基线的主要终点变化),泪膜破裂时间(TBUT)和眼部染色(合并/角膜/结膜);在每个时间点计算这些参数相对于基线的变化。每次访视时评估与治疗相关的不良事件(AE)。

结果

总体上,将242名受试者随机分组(OM3,n  = 120; ROA,n  = 122)。在第90天,两个治疗组的OSDI,眼部染色和TBUT均有明显改善。 对于联合眼部染色(所有时间点),角膜染色(第90天)和结​​膜染色(第30天),观察到在支持OM3方面存在显着(P <0.05)组间差异。ROA组(9.8%)高于OM3组(6.7%),与治疗相关的AE较高;视力模糊是最常见的不良事件之一(OM3为0%,ROA为4.1%)。

结论

这些发现支持了OM3(一种不含防腐剂的新型海藻糖和亚麻籽油的纳米乳液泪液配方)在治疗干眼症中的应用。

更新日期:2019-11-14
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