NCT00403715已完成3 期
A Multi-Center, Double-Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of Multiple Ocular Instillations of INS365 Ophthalmic Solution vs. Placebo in Subjects With Dry Eye Disease
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 500
- 主要终点
- change in dry eye testing measures and symptoms
研究概览
简要总结
The purpose of this trial is to compare the effectiveness and safety of INS365 Ophthalmic Solution with Placebo when applied topically in subjects with 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
- •at least mild severity in 2 of the 4 dry eye symptoms
- •unanesthetized Schirmer score of less than or equal to 7mm
- •corneal fluorescein staining of greater than or equal to 4 (out of 15)
排除标准
- •nasally stimulated Schirmer score of less than 3mm in subjects with an initial Schirmer score of 0mm
- •ongoing contact lens wear
- •current topical ophthalmic medication use
结局指标
主要结局
change in dry eye testing measures and symptoms
次要结局
- change in dry eye testing measures and symptoms
研究者
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