临床试验/NCT00519753

NCT00519753已完成4 期

Safety and Efficacy of Switching to the Travoprost/Timolol Maleate Fixed Combination (DUOTRAV®) From Prior Mono or Two-Drug Therapy in Germany

Alcon Research1 个研究点分布在 1 个国家目标入组 522 人开始时间: 2007年8月最近更新: 2016年11月18日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Alcon Research
入组人数: 522
试验地点: 1
主要终点: Change in intraocular pressure at 12 weeks from travoprost prior therapy (baseline)

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 study is to assess the safety and efficacy of transitioning uncontrolled glaucoma patients to DuoTrav from other mono or adjunctive therapies.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

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

•Adults with primary open-angle glaucoma, ocular hypertension or pigment dispersion glaucoma.
•Other protocol-defined inclusion criteria may apply.

排除标准

•Age related.
•Other protocol-defined exclusion criteria may apply.

研究组 & 干预措施

DuoTrav

Experimental

One drop in study eye(s) once daily in the evening (at 8:00 PM) for 12 weeks

干预措施: Travoprost 0.004%/timolol maleate 0.5% fixed combination ophthalmic solution (DuoTrav) (Drug)

结局指标

主要结局

Change in intraocular pressure at 12 weeks from travoprost prior therapy (baseline)

时间窗: Baseline and 12 weeks

次要结局

Change in intraocular pressure at 12 weeks from other prior therapies (baseline)(12 weeks)

研究者

发起方

Alcon Research

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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