NCT01211951已完成2 期
A Randomized, Double Blind, Placebo Controlled, Exploratory Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Corneal-conjunctival staining scores
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndromes.
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
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Corneal and conjunctival damage
- •Insufficiency of lacrimal secretion or tear film instability
- •Ocular symptom
排除标准
- •Severe ophthalmic disorder
- •Punctual plugs or surgery for occlusion of the lacrimal puncta
研究组 & 干预措施
KCT-0809 ophthalmic solution, low dose
Experimental
干预措施: KCT-0809 (Drug)
KCT-0809 ophthalmic solution, medium dose
Experimental
干预措施: KCT-0809 (Drug)
KCT-0809 ophthalmic solution, high dose
Experimental
干预措施: KCT-0809 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Corneal-conjunctival staining scores
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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