临床试验/NCT05550350

NCT05550350撤回3 期

A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery

EyePoint Pharmaceuticals, Inc.0 个研究点目标入组 150 人开始时间: 2022年9月1日最近更新: 2025年8月11日

适应症

干预措施

试验速览

阶段: 3 期
状态: 撤回
发起方: EyePoint Pharmaceuticals, Inc.
入组人数: 150
主要终点: Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8

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

A Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated With Cataract Surgery

详细描述

A Phase 3, Prospective, Randomized, Double-masked, Placebo-controlled, Parallel-design, Multicenter Study to Evaluate the Efficacy and Safety of DEXYCU® for the Treatment of Ocular Pain Associated with 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: Treatment
盲法: Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围: 40 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male or female subjects at least 40 years of age scheduled for cataract surgery
•Best corrected visual acuity (BCVA) of 20/30-20/200 in the study eye
•Must be considered by the investigator to have visual (VA) acuity potential greater than 20/30 in the study eye.

排除标准

•Use of any corticosteroids within 7 days prior to Day 0
•Injection of any corticosteroids, systemic immunomodulators or alkylating agents into any body tissue within 90 days
•Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening.

研究组 & 干预措施

DEXYCU

Experimental

DEXYCU, 103.4 mcg/mcl dexamethasone: equivalent dexamethasone dose: 517 mcg

干预措施: Dexycu (Drug)

Placebo

Placebo Comparator

Placebo/vehicle, 0 mcg/mcl dexamethasone: equivalent dexamethasone dose: 0 mcg

干预措施: Placebo/Vehicle (Other)

结局指标

主要结局

Proportion of subjects with absence of ocular pain (ie, score of '0') in the study eye at Day 8

时间窗: Day 8

次要结局

Proportion of subjects with absence of ocular pain in the study eye at Days 1, 3, 15, and 30(Days 1, 3, 15, and 30)
Rates of ocular (study eye and fellow eye) and non-ocular TEAEs(up to day 30)
Mean ocular pain scores in the study eye(Days 1, 3, 8, 15 and 30)
Proportion of subjects with absence of cells in the AC of the study eye(Days 1, 3, 8, 15 and 30)
Proportion of subjects with absence of flare in the AC of the study eye(Days 1, 3, 8, 15 and 30)
Mean AC cell score in the study eye(Days 1, 3, 8, 15 and 30)
Mean AC flare score in the study eye(Days 1, 3, 8, 15 and 30)

研究者

发起方

EyePoint Pharmaceuticals, Inc.

申办方类型

Industry

责任方

Sponsor

相似试验

已完成

不适用

DEXYCU (Dexamethasone Intraocular Suspension) 9% Retrospective Study 001Cataract

NCT04290676EyePoint Pharmaceuticals, Inc.527

Unknown

1 期

A Phase 1/2 Crossover Study to Assess EXP039 for Myopia or HyperopiaMyopiaHyperopia

NCT04883996Canyon City Eyecare60

已完成

4 期

The DEPOT Study (Dry Eye Prescription Options for Therapy)Dry Eye

NCT04911361Research Insight LLC50

已完成

3 期

Safety and Efficacy Study of Iontophoretic Dexamethasone Phosphate Ophthalmic Solution to Treat Non-Infectious Anterior Segment UveitisAnterior Uveitis

NCT01505088Eyegate Pharmaceuticals, Inc.193

已完成

2 期

Safety and Efficacy of Iontophoretic Dexamethasone Phosphate Delivery Prior to Implantation of a Posterior Chamber IOLCataract

NCT01602068Eyegate Pharmaceuticals, Inc.45