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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From: Medicine(Vol. 98, Issue 31)
Publisher: Lippincott Williams & Wilkins, WK Health
Document Type: Author abstract; Report
Length: 480 words

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Byline: Di Chen, Department of Ophthalmology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Shunhua Zhang, Department of Ophthalmology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Ailing Bian, Department of Ophthalmology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College; Jing Hong, Department of Ophthalmology, Peking University Third Hospital, Beijing; Yingping Deng, Department of Ophthalmology, West China Hospital, Sichuan University, Chengdu; Mingchang Zhang, Department of Ophthalmology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan; Wei Chen, School of Ophthalmology and Optometry and Eye Hospital, Wenzhou Medical University, Zhejiang; Yan Shao, Department of Ophthalmology, Second Affiliated Hospital of Dalian Medical College, Dalian, China.; Jialiang Zhao, Department of Ophthalmology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College Abstract 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 CONCLUSIONS:: Twice-daily instillation of 0.05% CsA OE was effective and well tolerated for the treatment of moderate to severe DED in Chinese population during the 3 months of the study.

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Gale Document Number: GALE|A595288093