NCT01606735已完成2 期
A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 for the Treatment of Inflammation Associated With Ocular Surgery
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
- 172
- 试验地点
- 2
- 主要终点
- Anterior Chamber Cell Count at Day 8 Post-Treatment
研究概览
简要总结
This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after ocular surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for unilateral cataract surgery
排除标准
- •Ocular, topical, or oral corticosteroids within 7 days of Day 0
研究组 & 干预措施
Dose 1
Experimental
干预措施: IBI-10090 (Drug)
Dose 2
Experimental
干预措施: IBI-10090 (Drug)
Dose 3
Experimental
干预措施: IBI-10090 (Drug)
结局指标
主要结局
Anterior Chamber Cell Count at Day 8 Post-Treatment
时间窗: 8 days post-treatment
This study will measure as its primary endpoint the anterior chamber cell count at Day 8 post-treatment. The proportion of patients with anterior chamber cell count = 0 at Day 8 for each dosage group will be compared.
次要结局
未报告次要终点
研究者
研究点 (2)
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