NCT00904904已完成4 期
Indomethacin Eyedrops Compared With Ketorolac Eyedrops for Ocular Inflammation Following Cataract Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Aqueous flare
研究概览
简要总结
This study is being conducted to show that indomethacin is at least as effective as ketorolac for the prevention of ocular inflammation following 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
- Prevention
- 盲法
- Single (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
- •Subjects must be planning to undergo cataract surgery on one eye by phacoemulsification with posterior chamber intraocular lens, using topical or general anaesthesia.
- •Subjects must have a preoperative flare ≤ 15 ph/ms, measured with a laser flare meter(LFM) without pharmacological pupil dilation, within the 2 months preoperatively.
排除标准
- •Subjects who have any progressive pathology requiring the use of topical or systemic anti-inflammatory or anti-infectious agents.
- •Subjects who take acetylsalicylic acid at doses > 100 mg daily and cannot discontinue usage during the study.
- •Subjects who have a history of asthma linked to acetylsalicylic acid or other nonsteroidal anti-inflammatory (NSAI) drug administration.
- •Subjects with immunodepression.
- •Subjects with a history of intolerance to the study drug or to any NSAI drug.
- •Subjects who are monocular for any reason other than cataract.
- •Subjects who are treated with local or systemic anti-inflammatory drugs within 10 days prior to inclusion.
研究组 & 干预措施
Indomethacin
Experimental
Indomethacin ophthalmic solution 0.1% for post-surgical inflammation
干预措施: Indomethacin ophthalmic solution (Drug)
Ketorolac
Active Comparator
Ketorolac ophthalmic solution 0.5% for post-surgical inflammation
干预措施: Ketorolac Ophthalmic Solution (Drug)
结局指标
主要结局
Aqueous flare
时间窗: Post-operative day 1 & day 7
次要结局
- Change from baseline of retinal thickness(Postoperative day 30 & day 90)
- Aqueous flare(Postoperative day 30 and day 90)
研究者
研究点 (1)
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