NCT00853970已完成3 期
Efficacy Study of Bromfenac Ophthalmic Solution in Patients Undergoing 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
- 299
- 试验地点
- 1
- 主要终点
- Summed Ocular Inflammation Score (SOIS) of Zero
研究概览
简要总结
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 0.09%
Experimental
dosed 1 drop daily in study eye for 2 weeks
干预措施: Bromfenac Ophthalmic Solution (Drug)
Placebo
Placebo Comparator
dosed 1 drop daily in study eye for 2 weeks
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Summed Ocular Inflammation Score (SOIS) of Zero
时间窗: Day 15 (Primary Endpoint)
Participants with SOIS of 0. Measured on a scale of 0-4: 0=0 cells (complete absence); 0.5=1-5 cells ; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=\>50 cells (intense)
次要结局
- Pain Free(Day 1)
研究者
研究点 (1)
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