NCT01605942终止1 期
A Safety and Efficacy Study of a Dexamethasone Drug Delivery System for Postoperative Inflammation and Pain After Cataract Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Allergan
- 入组人数
- 8
- 主要终点
- Number of Patients With Clearance of Anterior Chamber Inflammation
研究概览
简要总结
This is a safety and efficacy study of a Dexamethasone Drug Delivery System for anterior segment inflammation and pain following cataract extraction with 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
- Triple (Participant, Care Provider, 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
- •Planned single cataract extraction with lens implant
- •Best-corrected visual acuity of 20/200 or better in the opposite eye
排除标准
- •Glaucoma or history of intraocular hypertension in the study eye
- •History of chronic ocular allergy in the last year requiring treatment
- •Scheduled for cataract surgery in the non-study eye during study participation
研究组 & 干预措施
Dexamethasone Drug Delivery System
Experimental
Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
干预措施: Dexamethasone Drug Delivery System (Drug)
Placebo Drug Delivery System
Placebo Comparator
Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
干预措施: Placebo Drug Delivery System (Drug)
结局指标
主要结局
Number of Patients With Clearance of Anterior Chamber Inflammation
时间窗: Up to Day 71
The anterior chamber is the area in front of the iris (colored part of the eye). Inflammation is measured on a scale ranging from 0 (best) to 8 (worst).
次要结局
- Plasma Levels of Dexamethasone(Day 2, Day 7, Day 14)
研究者
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