NCT01675570已完成2 期
A Phase II, Multi-Center, Randomized, Placebo-Controlled, Double-Masked Study of RX-10045 (0.09%) in the Treatment of Dry Eye Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Corneal staining
研究概览
简要总结
The primary purpose of this study is to assess the efficacy, tolerability and safety of RX-10045 Ophthalmic Solution in patients 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 (Participant, Investigator)
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
- •Have a patient reported history of dry eye in both eyes
- •Presence of dry eye symptoms
- •Presence of dry eye signs, destabilized tear film break-up time and corneal staining
排除标准
- •Known contraindications or sensitivities to study medication or its components
- •Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters
- •Use of disallowed medication during the period indicated prior to the enrollment or during the study
- •Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control
研究组 & 干预措施
RX-10045 active arm
Experimental
RX-10045 Opththalmic Solution, 0.09%
干预措施: RX-10045 (Drug)
Vehicle for RX-10045 arm
Placebo Comparator
Vehicle of RX-10045 Ophthalmic Solution
干预措施: Vehicle for RX-10045 (Drug)
结局指标
主要结局
Corneal staining
时间窗: Baseline to day 28
Worst symptom score
时间窗: Baseline to day 28
次要结局
- Ocular discomfort symptom score(Baseline to day 28)
- Tear film break-up time(Baseline to day 28)
- Visual-related function subscale of Ocular Surface Disease Index score(Baseline to day 28)
研究者
研究点 (1)
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