NCT01030237已完成不适用
An Evaluation of the Safety and Efficacy of FID 114657
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 主要终点
- Tear Break-Up Time (TBUT)
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of FID 114657 in comparison to Soothe XP in a specified population of dry eye patients.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Documented diagnosis of dry eye
- •NaFl Corneal Staining sum score ≥ 3 in either eye
排除标准
- •Must not have worn contact lenses for 1 week preceding enrollment
研究组 & 干预措施
FID 114657
Experimental
FID 114657
干预措施: FID 114657 (Other)
Soothe XP Lubricant Eye Drops
Active Comparator
Soothe XP Lubricant Eye Drops
干预措施: Soothe XP Lubricant Eye Drops (Other)
结局指标
主要结局
Tear Break-Up Time (TBUT)
时间窗: measured at Days 0, 7, 14, 28 and 42
Corneal Staining
时间窗: measured at Days 0, 7, 14, 28 and 42
Conjunctival Staining
时间窗: measured at Days 0, 7, 14, 28 and 42
次要结局
未报告次要终点
研究者
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