NCT02736175已完成3 期
A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase 3C Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After 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
- 438
- 主要终点
- Absence of Anterior Chamber Inflammation
研究概览
简要总结
The objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular 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
- Double (Participant, 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
- •Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of posterior chamber lens
- •Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes
排除标准
- •Any intraocular inflammation in the study eye present during the screening slit lamp examination
- •Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening
- •Any intraocular inflammation in the study eye present during the screening slit lamp examination
研究组 & 干预措施
OTX-DP
Experimental
OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use
干预措施: Dexamethasone (Drug)
PV
Placebo Comparator
PV (placebo drug delivery vehicle)
干预措施: Placebo Vehicle (Other)
结局指标
主要结局
Absence of Anterior Chamber Inflammation
时间窗: Day 14
Absence of cells (i.e., score of '0') in the anterior chamber of the study eye at Day 14
Absence of Ocular Pain
时间窗: Day 8
Absence of pain (i.e., score of '0') in the study eye at Day 8
次要结局
未报告次要终点
研究者
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