NCT01367249已完成3 期
Efficacy and Safety of Bromfenac Ophthalmic Solution vs. Placebo for the Treatment of Ocular 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
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Ocular Inflammation
研究概览
简要总结
This is an efficacy study of Bromfenac Ophthalmic Solution in 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
- •Male or female at least 18 years of age who are scheduled for unilateral cataract surgery
排除标准
- •Have known hypersensitivity to bromfenac or to any component of the investigational product
研究组 & 干预措施
Bromfenac Ophthalmic Solution
Experimental
Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
干预措施: Bromfenac Ophthalmic Solution (Drug)
Placebo
Placebo Comparator
One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
干预措施: Placebo (Drug)
结局指标
主要结局
Ocular Inflammation
时间窗: Day 15
The proportion of subjects who had cleared ocular inflammation summed ocular inflammation score (SOIS) of grade 0 by Day 15.
次要结局
- Ocular Pain(Day 1)
研究者
研究点 (1)
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