临床试验/NCT02736175

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

Ocular Therapeutix, Inc.0 个研究点目标入组 438 人开始时间: 2015年10月最近更新: 2017年11月13日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Ocular Therapeutix, Inc.
入组人数: 438
主要终点: Absence of Anterior Chamber Inflammation

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

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

发起方

Ocular Therapeutix, Inc.

申办方类型

Industry

责任方

Sponsor

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