临床试验/NCT00652106

NCT00652106已完成3 期

Safety and Efficacy Study of Brimonidine/Timolol Fixed Combination in Patients With Glaucoma or Ocular Hypertension

Allergan0 个研究点目标入组 432 人开始时间: 2003年6月最近更新: 2008年4月3日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方: Allergan
入组人数: 432
主要终点: Intraocular pressure (IOP)

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

This study evaluates the safety and efficacy of brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution compared with concurrent brimonidine 0.2% and timolol ophthalmic solutions

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

•Diagnosis of ocular hypertension or glaucoma
•Patient requires IOP-lowering therapy in both eyes

排除标准

•Uncontrolled medical conditions
•Contraindication to β-adrenoceptor antagonist therapy or brimonidine therapy

研究组 & 干预措施

1

Experimental

0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution

干预措施: 0.2% brimonidine/0.5% timolol fixed combination ophthalmic solution (Drug)

2

Active Comparator

Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution

干预措施: Concurrent brimonidine 0.2% and Timolol 0.5% ophthalmic solution (Drug)

3

Active Comparator

0.2% brimonidine ophthalmic solution

干预措施: Brimonidine 0.2% ophthalmic solution (Drug)

结局指标

主要结局

Intraocular pressure (IOP)

时间窗: Day 28

次要结局

未报告次要终点

研究者

发起方

Allergan

申办方类型

Industry

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