NCT01214174终止2 期
A Multicenter, Randomized, Double-masked, Dose-ranging, Phase 2 Study to Evaluate the Efficacy and Safety of IBI-10090 in Treating Inflammation in Cataract Surgery Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Proportion of Patients With Anterior Chamber Cell Clearing 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 cataract 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
- Triple (Participant, 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
- •Male or female patients 40 years of age scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation.
排除标准
- •Patients who have used any ocular, topical, or oral corticosteroids within 7 days prior to Day
- •Patients who have used topical ocular NSAIDs in the study eye within 15 days prior to screening.
- •Patients with any signs of intraocular inflammation in either eye at screening.
- •Patients who have received any prior intravitreal injections in the study eye.
研究组 & 干预措施
Dose 1
Experimental
513ug
干预措施: IBI-10090 (Drug)
Dose 2
Experimental
776ug
干预措施: IBI-10090 (Drug)
Dose 3
Experimental
1046ug
干预措施: IBI-10090 (Drug)
结局指标
主要结局
Proportion of Patients With Anterior Chamber Cell Clearing 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 in the study eye. The proportion of patients with anterior chamber cell count = 0 at Day 8 in the study eye for each dosage group will be compared. Only one eye was treated per participant.
次要结局
未报告次要终点
研究者
研究点 (1)
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