NCT00332774已完成3 期
A 3-Month Clinical Safety Comparison of Nevanac 0.1% to Acular LS 0.4% and Vehicle 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
- 149
- 试验地点
- 1
- 主要终点
- Macular thickness
研究概览
简要总结
The purpose of this study is to determine the safety of Nevanac 0.1% compared to Acular LS 0.4% and Vehicle in patients treated before cataract surgery and for approximately 90 days following 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
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of any race or sex ages 10 years or older undergoing 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
Nevanac
Experimental
干预措施: Nepafenac ophthalmic solution 0.1% (Drug)
Acular
Active Comparator
干预措施: Ketorolac Tromethamine ophthalmic solution 0.4% (Drug)
Vehicle
Placebo Comparator
干预措施: Nepafenac ophthalmic suspension vehicle (Other)
结局指标
主要结局
Macular thickness
次要结局
- contrast sensitivity, corneal staining, VA, IOP, slit-lamp parameters, fundus parameters
研究者
研究点 (1)
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