Efficacy and safety of 0.05% cyclosporine ophthalmic emulsion in treatment of Chinese patients with moderate to severe dry eye disease: A 12-week, multicenter, randomized, double-masked, placebo-controlled phase III clinical study
Efficacy and safety of 0.05% cyclosporine ophthalmic emulsion in treatment of Chinese patients with moderate to severe dry eye disease: A 12-week, multicenter, randomized, double-masked, placebo-controlled phase III clinical study
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DOI：
10.1097/md.0000000000016710
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发表时间：
2019-08-01
期刊：
影响因子：
1.6
通讯作者：
Zhao, Jialiang
中科院分区：
文献类型：
--
作者：
Chen, Di;Zhang, Shunhua;Zhao, Jialiang
背景：干眼病（DED）是一种慢性眼表疾病，影响全球数亿人。虽然0.05%环孢素眼用乳剂（CsA OE）在美国长期以来一直用于治疗DED，但在中国尚未上市。我们的研究旨在比较0.05%环孢素A OE与车辆在中国患者中重度DED.Methods的疗效和安全性：这是一个多中心，随机，双盲，2平行臂，3个月的III期研究。中度至重度DED患者随机接受0.05% CsA OE或其溶剂，每日两次，沿着不含防腐剂的羟丙甲纤维素滴眼液，每日3次。在第7、28、56和84天以及停药后2周对患者进行随访，以进行安全性评估。CsA OE组的总有效率（OER）和疗效指数均明显优于溶媒组（P
Background: Dry eye disease (DED) is a chronic ocular surface disease that affects hundreds of millions of people worldwide. Although 0.05% cyclosporine ophthalmic emulsion (CsA OE) has long been prescribed in the U.S. for the treatment of DED, it is not commercially available in China. Our study aims to compare the efficacy and safety profile of 0.05% CsA OE versus vehicle in Chinese patients with moderate to severe DED.Methods: This was a multicenter, randomized, double-masked, 2-parallel-arm, 3-month phase III study. Patients with moderate to severe DED were randomized to receive twice-daily 0.05% CsA OE or its vehicle, along with unpreserved hypromellose eye drops 3 times per day. Patients were followed up at day 7, 28, 56, and 84, as well as 2 weeks after the medications were discontinued for safety assessment.Results: A total of 240 patients were randomized. The overall effective rate (OER) and efficacy index were significantly better in the CsA OE than vehicle group at all follow up times (all P