NCT00140049已完成4 期
A 12-Week Randomized, Evaluator-Masked, Parallel-Group, Multinational, Multi-Center Study Comparing The Efficacy And Safety Of The Fixed Combination Of Latanoprost And Timolol (Xalacom) With The Fixed Combination Of Dorzolamide And Timolol (Cosopt) In Patients With Open-Angle Glaucoma Or Ocular Hypertension.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.26 个研究点 分布在 5 个国家目标入组 238 人开始时间: 2005年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 26
- 主要终点
- The mean IOP measurements obtained in the study eye at each time point
研究概览
简要总结
To demonstrate the statistical non inferiority of the combination of latanoprost and timolol given in the evening time once a day vs the combination of dorzamalide and timolol twice a day based on intraocular pressure measurements at 8 AM, 12 noon & 4 PM during a 12 week treatment.
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
- Single
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
- •Uni- or bilateral diagnosis of primary open angle glaucoma or ocular hypertension on beta-blocker monotherapy or dual therapy in which at least one medication is a beta-blocker for at least 4 weeks prior to screening
排除标准
- •Closed/ barely open anterior chamber angle or history of acute angle closure glaucoma.
- •History of ALT (Argon Laser Trabeculoplasty) or SLT(selective Laser) within 3 months prior to screening
结局指标
主要结局
The mean IOP measurements obtained in the study eye at each time point
次要结局
未报告次要终点
研究者
研究点 (26)
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不适用
Crossover comparative study of latanoprost/timolol fixed combination with combined therapy comprised of latanoprost and timololglaucoma, ocular hypertensionJPRN-UMIN000005426Department of Ophthalmology, Gifu University Graduate School of Medicine40