NCT01294956已完成不适用
A Clinical Evaluation of an Investigational Lubricant Eye Gel (FID 115958D)
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
- 147
- 主要终点
- Corneal Staining
研究概览
简要总结
The purpose of this study is to estimate the change in sodium fluorescein staining, as a sign of dry eye, during six weeks of treatment with FID 115958D or Refresh Liquigel.
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
- •Current use of a lubricant eye gel or ointment at least once per week (over the previous month)
排除标准
- •No contact lenses wear throughout the study period
- •Must not have had punctal plugs inserted within 30 days preceding enrollment
研究组 & 干预措施
FID 115958D
Experimental
Lubricant Eye Drop
干预措施: Lubricant Eye Drop (Other)
Refresh Liquigel
Active Comparator
Lubricant Eye Drop
干预措施: Refresh Liquigel (Other)
结局指标
主要结局
Corneal Staining
时间窗: Day 42
次要结局
未报告次要终点
研究者
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