NCT02617095终止不适用
Comparison of the Efficacy and Safety of T2762 Versus Optive® in the Treatment of Moderate to Severe Dry Eye Syndrome
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Change of the symptomatology evaluation on a Visual Analogic Scale
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of T2762 versus Optive® 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 ≥ 18 years old.
- •Diagnosis of moderate to severe dry eye syndrome
排除标准
- •Pregnancy, lactation.
- •Childbearing potential woman who is not using a reliable method of contraception and is not surgically sterilised.
- •Inability of patient to understand the study procedures and thus inability to give informed consent.
- •Non-compliant patient
- •Participation in another clinical study at the same time as the present study.
- •Participation to the present study during the exclusion period of another clinical study.
- •Already included once in this study.
- •Ward of court.
- •Patient not covered by government health care scheme
研究组 & 干预措施
Optive
Active Comparator
One drop of Optive in each eye 3 to 6 times daily
干预措施: Optive (Device)
T2762
Experimental
One drop of T2762 in each eye 3 to 6 times daily
干预措施: T2762 (Device)
结局指标
主要结局
Change of the symptomatology evaluation on a Visual Analogic Scale
时间窗: Day 28
次要结局
未报告次要终点
研究者
研究点 (1)
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