临床试验/NCT00616993

NCT00616993已完成3 期

Study of Difluprednate in the Treatment of Inflammation Following Ocular Surgery (ST-601-004)

Sirion Therapeutics, Inc.1 个研究点分布在 1 个国家目标入组 120 人开始时间: 2008年1月最近更新: 2011年7月1日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Sirion Therapeutics, Inc.
入组人数: 120
试验地点: 1
主要终点: The proportion of subjects with an anterior chamber cell grade of "0" and a flare grade of "0" on Day 14, compared between difluprednate and placebo groups.

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研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this phase III study is to determine the safety and efficacy of difluprednate in the treatment of inflammation following ocular 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: Double (Participant, Investigator)

入排标准

年龄范围: 2 Years 至 —（Child, Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Scheduled for unilateral ocular surgery.

排除标准

•Systemic administration of any corticosteroid or immunosuppressive drug in the 2 weeks prior to study enrollment.

研究组 & 干预措施

2

Placebo Comparator

Vehicle

干预措施: Placebo (Other)

1

Experimental

Difluprednate

干预措施: Difluprednate (Drug)

结局指标

主要结局

The proportion of subjects with an anterior chamber cell grade of "0" and a flare grade of "0" on Day 14, compared between difluprednate and placebo groups.

时间窗: Day 14

次要结局

The proportion of subjects with an anterior chamber cell grade of "0" and a flare grade of "0" on Day 7, compared between difluprednate and placebo groups.(Day 7)

研究者

发起方

Sirion Therapeutics, Inc.

申办方类型

Industry

研究点 (1)

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