NCT01558999已完成2 期
A Clinical Study Evaluating the Safety and Efficacy of SI-614 Ophthalmic Solution in Patients With Dry Eye
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
- Mean change from baseline in symptom score
研究概览
简要总结
The purpose of this study is to assess the safety and effectiveness of SI-614 solution compared with placebo solution in treating patients with dry eye
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
- •Be at least 18 years of age
- •Have provided written informed consent
- •Have dry eye in both eyes
排除标准
- •Use of contact lenses
- •Have an uncontrolled systemic disease
- •Have a history of an uncontrolled psychiatric condition, or substance or alcohol abuse
- •Women who is pregnant, nursing or planning a pregnancy
研究组 & 干预措施
High concentration SI-614
Experimental
干预措施: High concentration SI-614 (Drug)
Low concentration SI-614
Experimental
干预措施: Low concentration SI-614 (Drug)
Vehicle
Placebo Comparator
干预措施: Vehicle (Drug)
结局指标
主要结局
Mean change from baseline in symptom score
时间窗: Day 21 - 27
Mean change from baseline in TFBUT
时间窗: Day 27
次要结局
未报告次要终点
研究者
研究点 (1)
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