新型脂质基眼药水与水性眼药水治疗干眼症的比较：一项多中心随机对照试验。

Comparison of novel lipid-based eye drops with aqueous eye drops for dry eye: a multicenter, randomized controlled trial.

作者信息

Simmons Peter A, Carlisle-Wilcox Cindy, Vehige Joseph G

机构信息

Ophthalmology Research and Development, Allergan, Inc., Irvine, CA, USA.

出版信息

Clin Ophthalmol. 2015 Apr 15;9:657-64. doi: 10.2147/OPTH.S74849. eCollection 2015.

DOI:10.2147/OPTH.S74849

PMID:25931806

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4404875/

Abstract

BACKGROUND

Dry eye may be caused or exacerbated by deficient lipid secretion. Recently, lipid-containing artificial tears have been developed to alleviate this deficiency. Our study compared the efficacy, safety, and acceptability of lipid-containing eye drops with that of aqueous eye drops.

METHODS

A non-inferiority, randomized, parallel-group, investigator-masked multicenter trial was conducted. Subjects with signs and symptoms of dry eye were randomized to use one of two lipid-containing artificial tears, or one of two aqueous artificial tears. Subjects instilled assigned drops in each eye at least twice daily for 30 days. The primary efficacy analysis tested non-inferiority of a preservative-free lipid tear formulation (LT UD) to a preservative-free aqueous tear formulation (AqT UD) for change in Ocular Surface Disease Index (OSDI) score from baseline at day 30. Secondary measures included OSDI at day 7, tear break-up time (TBUT), corneal and conjunctival staining, Schirmer's test, acceptability and usage questionnaires, and safety assessments.

RESULTS

A total of 315 subjects were randomized and included in the analyses. Subjects reported instilling a median of three doses of study eye drops per day in all groups. At days 7 and 30, all groups showed statistically significant improvements from baseline in OSDI (P<0.001) and TBUT (P≤0.005). LT UD was non-inferior to AqT UD for mean change from baseline in OSDI score at day 30. No consistent or clinically relevant differences for the other efficacy variables were observed. Acceptability was generally similar across the groups and there was a low incidence of adverse events.

CONCLUSION

In this heterogeneous population of dry eye subjects, there were no clinically significant differences in safety, effectiveness, and acceptability between lipid-containing artificial tears and aqueous eye drops. The results suggest that lipid-containing artificial tears can be used to counteract lipid deficiency that is common in dry eye, without compromising overall acceptability.

摘要

背景

睑板腺分泌不足可能导致或加重干眼。近年来，含脂质人工泪液已被研发出来以缓解这种不足。我们的研究比较了含脂质滴眼液与水性滴眼液的疗效、安全性和可接受性。

方法

进行了一项非劣效性、随机、平行组、研究者设盲的多中心试验。有干眼体征和症状的受试者被随机分配使用两种含脂质人工泪液之一，或两种水性人工泪液之一。受试者每天至少两次在每只眼中滴入指定的滴眼液，持续30天。主要疗效分析测试了无防腐剂的脂质泪液制剂（LT UD）相对于无防腐剂的水性泪液制剂（AqT UD）在第30天时眼表疾病指数（OSDI）评分相对于基线的变化的非劣效性。次要指标包括第7天时的OSDI、泪膜破裂时间（TBUT）、角膜和结膜染色、Schirmer试验、可接受性和使用问卷以及安全性评估。

结果

共有315名受试者被随机分组并纳入分析。所有组的受试者报告每天滴入研究滴眼液的中位数为三剂。在第7天和第30天，所有组在OSDI（P<0.001）和TBUT（P≤0.005）方面均显示出相对于基线有统计学意义的改善。在第30天时，LT UD在OSDI评分相对于基线的平均变化方面不劣于AqT UD。未观察到其他疗效变量有一致的或临床相关的差异。各组的可接受性总体相似，不良事件发生率较低。