A Multi-Center, Parallel Group, Double-Masked, Randomized, Placebo-Controlled Study of Multiple Ocular Instillations of Diquafosol Tetrasodium Ophthalmic Solution, 2% in Subjects With Dry Eye Disease

Merck Sharp & Dohme LLC0 个研究点目标入组 640 人开始时间: 2004年6月最近更新: 2016年2月22日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Merck Sharp & Dohme LLC
入组人数: 640
主要终点: Change in dry eye testing measures

研究概览研究设计入排标准结局指标研究者记录与标识符相似试验

研究概览

简要总结

The purpose of this trial is to assess the effectiveness and safety of 2% diquafosol tetrasodium ophthalmic solution versus placebo following 6 weeks of treatment in subjects with mild to moderate dry eye disease.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Double

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•best corrected visual acuity in both eyes of at least +0.7
•six-month documented history of dry eye disease
•as least mild severity in 1 of the 5 dry eye symptoms
•corneal fluorescein staining of greater than or equal to 3 and less than or equal to 6 (out of 15)

排除标准

•permanent conjunctival goblet cell loss or scarring conditions
•ongoing contact lens wear
•current topical ophthalmic medication use

结局指标

主要结局

Change in dry eye testing measures

次要结局

Change in dry eye testing measures and symptoms

研究者

发起方

Merck Sharp & Dohme LLC

申办方类型

Industry

责任方

Sponsor

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