NCT00405730已完成3 期
Nepafenac 0.1% Eye Drops, Suspension Compared to Ketorolac Trometamol 0.5% Eye Drops, Solution and Placebo (Nepafenac Vehicle) for the Prevention and Treatment of Ocular Inflammation and Ocular Pain Associated With Cataract Surgery: European Study
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
- 227
- 试验地点
- 1
- 主要终点
- Percentage of Patients with Day 14 Cure
研究概览
简要总结
To evaluate the safety and efficacy of Nepafenac 1 mg/ml Eye Drops, Suspension, compared to Placebo and Ketorolac Trometamol 5 mg/ml Eye Drops, Solution for the prevention and treatment of ocular inflammation and ocular pain after cataract extraction with IOL 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, Outcomes Assessor)
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 (18 years or older) of any race and either sex, requiring cataract extraction with planned implantation of a posterior chamber intraocular lens.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Nepafenac
Experimental
One drop in the study eye 3 times daily for 23 days
干预措施: Nepafenac 1mg/ml eye drops, suspension (Drug)
Ketorolac Trometamol
Active Comparator
One drop in the study eye 3 times daily for 23 days
干预措施: Ketorolac Trometamol 5 mg/ml eye drops, solution (Drug)
Nepafenac Vehicle
Placebo Comparator
One drop in the study eye 3 times daily for 23 days
干预措施: Nepafenac vehicle eye drops (Other)
结局指标
主要结局
Percentage of Patients with Day 14 Cure
时间窗: Day 14
Cure is defined as aqueous cells score = 0 and aqueous cells score = 0 at Day 14.
次要结局
未报告次要终点
研究者
研究点 (1)
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