NCT02023268已完成3 期
Phase III: Comparison of the Efficacy and Safety of T2762 and Vismed® in the Treatment of Moderate to Severe Dry Eye Syndrome
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Global Ocular Staining (With Oxford Scale - Ranges : 0-15)
研究概览
简要总结
Comparison of the efficacy and safety of T2762 and Vismed® in the treatment of moderate to severe Dry Eye Syndrome
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
- Single (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
- •Signed and dated informed consent
- •Male or female aged from ≥ 18 years old.
- •Known Dry Eye Syndrome requiring artificial tears within the last 3 months prior to study selection.
排除标准
- •Best far corrected visual acuity < 1/10
- •Severe blepharitis
- •Severe Dry Eye
研究组 & 干预措施
Vismed®
Active Comparator
干预措施: Vismed® (Device)
T2762
Experimental
干预措施: T2762 (Device)
结局指标
主要结局
Global Ocular Staining (With Oxford Scale - Ranges : 0-15)
时间窗: Baseline and Day 35
Change from Baseline in the worse eye on Day 35 (decrease of Oxford score = better outcome) Global Ocular Staining With the Oxford Scale measured surface damage to treated eyes(by T2762 or vismed).
次要结局
未报告次要终点
研究者
研究点 (1)
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