NCT00524264已完成3 期
A Study of Ketorolac for the Treatment of Inflammation and Pain Associated With Cataract Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 248
- 主要终点
- Resolution of Post Operative Inflammation
研究概览
简要总结
This is a 16-day study to evaluate the safety and efficacy of ketorolac eye drops for the treatment of inflammation and pain associated with 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
- Double (Participant, 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
- •Patients undergoing cataract surgery
排除标准
- •Uncontrolled ocular disease in cataract surgery eye
研究组 & 干预措施
1
Experimental
干预措施: ketorolac (Drug)
2
Placebo Comparator
干预措施: ketorolac (Drug)
结局指标
主要结局
Resolution of Post Operative Inflammation
时间窗: Day 14
Anterior chamber inflammation is the sum of biomicroscopic cell and flare; each measured on a scale of 0-4 (Flare: 0 = no flare, 4 = intense flare / Cell: 0 = no cells, 4 = \>50 cells)
次要结局
- Ocular Pain(Day 1)
- Mean Pupil Area(Day 0)
研究者
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