NCT00348517已完成不适用
An Evaluation of the Safety and Efficacy of Systane Free FID 105783
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
- 100
- 主要终点
- Change in corneal staining at Day 28 from baseline (Day 0)
研究概览
简要总结
The objective of this study is to evaluate the safety and efficacy of Systane Free FID 105783 when compared to Refresh Liquigel Lubricant Eye Drops (Allergan) 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
- 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
- •>/= 3 corneal staining score using NEI scoring system.
- •Need artificial tears at least some of the time.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •History or evidence of ocular or intraocular surgery in either eye within the past six months.
- •History of intolerance or hypersensitivity to any component of the study medication.
- •Use of Restasis within 30 days of Visit
- •Participation in an investigational drug or device study within 30 days of entering this study.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Refresh
Active Comparator
干预措施: Refresh Liquigel Lubricant Eye Drops (Other)
Systane
Experimental
干预措施: Systane Free Lubricant Eye Drops (Other)
结局指标
主要结局
Change in corneal staining at Day 28 from baseline (Day 0)
时间窗: Day 28
次要结局
未报告次要终点
研究者
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