NCT01666210已完成2 期
A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase II 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
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Absence of Pain in the Study Eye
研究概览
简要总结
To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of ocular inflammation and pain in subjects who have undergone cataract extraction with intra-ocular 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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has provided written informed consent, approved by the appropriate institutional review board; and is able to comply with study requirements and visit schedule
- •Is greater than or equal to 21 years of age
- •Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens
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 at Screening
- •Compromised immune system or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface
研究组 & 干预措施
Dexamethasone Punctum Plug
Active Comparator
Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days
干预措施: OTX-DP (Dexamethasone punctum plug) (Drug)
Placebo Vehicle Punctum Plug
Placebo Comparator
Placebo punctum plug insertion
干预措施: Placebo Vehicle Punctum Plug (Drug)
结局指标
主要结局
Absence of Pain in the Study Eye
时间窗: Day 8
Absence of Cells in Anterior Chamber of Study Eye
时间窗: Day 8
次要结局
未报告次要终点
研究者
研究点 (1)
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