NCT00198445已完成3 期
Efficacy and Safety of Topical Bromfenac Ophthalmic Solution, 0.1% vs. Placebo for Treatment of Ocular Inflammation Following 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
- 527
- 试验地点
- 39
- 主要终点
- Ocular Inflammation Score
研究概览
简要总结
The primary objective of this study was to investigate the efficacy of bromfenac sodium ophthalmic solution 0.09% for treatment of post-operative ocular inflammation in subjects who undergo cataract extraction and intraocular lens implantation. The secondary objective was to investigate the safety and tolerability of the same.
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, Care Provider)
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
- •Cataract surgery
- •Summed ocular inflammation score (anterior chamber cell score plus flare score) of >/= 3, 24 hours after the cataract extraction
- •Agreed to avoid disallowed medications (meds) throughout the duration of the study
排除标准
- •Use of or need for non-steroidal anti-inflammatory agents (NSAIDs), steroids, anticoagulants, or other specific meds prohibited by the protocol
- •Uncontrolled chronic ocular or systemic disease, active corneal pathology or scarring noted in either eye (except keratopathy, allowed in non-study eye)
- •Extraocular/intraocular inflammation in either eye
- •Clinically significant (WHO CTC Grade 1 or greater) liver function tests
研究组 & 干预措施
Bromfenac
Experimental
Topical bromfenac ophthalmic solution 0.1%
干预措施: Bromfenac (Drug)
Placebo
Placebo Comparator
Vehicle of bromfenac
干预措施: Placebo (Drug)
结局指标
主要结局
Ocular Inflammation Score
时间窗: Visit 4 (Day 15)
Cleared ocular inflammation in the study eye, defined as summed ocular inflammation score (SOIS) of 1 or less (anterior chamber cell score plus flare score, each measured on a 5-point scale) 0=none
次要结局
- Mean Ocular Inflammation Score(At each Visit 2 (Day3), Visit 3 (Day 8), Visit 4 (Day 15), Visit 5 (Day 22))
研究者
研究点 (39)
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