NCT00333918已完成3 期
Efficacy and Safety Study of Topical Bromfenac Ophthalmic Solution vs. Placebo for 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
- 522
- 主要终点
- Reduction of ocular inflammation
研究概览
简要总结
The primary objective of this study is to investigate the efficacy and safety of bromfenac ophthalmic solution for treatment of ocular inflammation and pain in subjects who undergo cataract extraction and intraocular lens implantation.
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
- •Scheduled for unilateral cataract surgery with no other ophthalmic surgical procedures planned during cataract surgery
- •Agree to return for all required visits
- •Agree to avoid disallowed medications
排除标准
- •Known hypersensitivity to bromfenac and salicylates
研究组 & 干预措施
1-bromfenac ophthalmic solution
Experimental
sterile ophthalmic solution
干预措施: bromfenac ophthalmic solution (Drug)
2-placebo comparator
Placebo Comparator
sterile ophthalmic solution
干预措施: placebo comparator (Drug)
结局指标
主要结局
Reduction of ocular inflammation
次要结局
- Secondary efficacy outcome for ocular pain will be the proportion of treated subjects that are pain free
研究者
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