NCT03874429已完成不适用
Comparison of the Performance and Safety of T2259 Versus Vismed Multi in Dry Eye Patients With Superficial Keratitis.
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
- 101
- 试验地点
- 1
- 主要终点
- Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : 0-15)
研究概览
简要总结
The purpose of this study is to compare the performance and safety of T2259 versus Vismed Multi in dry eye patients with superficial keratitis.
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)
盲法说明
investigator-masked
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
- •Main inclusion Criteria:
- •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
- •Far best-corrected visual acuity≤2/10
- •Severe Blepharitis
研究组 & 干预措施
T2259
Experimental
1 drop in each eye 2 to 4 times daily
干预措施: T2259 (Device)
Vismed Multi
Active Comparator
1 drop in each eye 2 to 4 times daily
干预措施: Vismed multi (Device)
结局指标
主要结局
Surface Ocular Staining With Fluorescein (With Oxford Scale - Ranges : 0-15)
时间窗: Baseline and Day 35
Change from baseline in the worse eye at Day 35 in Global Ocular staining (decrease of oxford score = better outcome)
次要结局
未报告次要终点
研究者
研究点 (1)
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