NCT02845674已完成3 期
An Open-Label Extension of a Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 258
- 主要终点
- Adverse Events
研究概览
简要总结
This is a safety extension enrolling subjects participating in Study OTX-101-2016-001 (NCT02688556)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Completion of Study OTX-101-2016-001
排除标准
- 未提供
研究组 & 干预措施
OTX-101 0.09%
Experimental
0.09% cyclosporine nanomicellar solution
干预措施: OTX-101 0.09% (Drug)
结局指标
主要结局
Adverse Events
时间窗: 40 weeks
Number of subjects reporting any AEs
次要结局
未报告次要终点
研究者
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