NCT00862472撤回3 期
Safety and Efficacy Study of DuoTrav APS Versus DuoTrav
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 主要终点
- Mean Intraocular Pressure (IOP)
研究概览
简要总结
The purpose of the study is to demonstrate that the IOP-lowering efficacy of DuoTrav APS, dosed once-daily in the morning, is non-inferior to that of DuoTrav, dosed once-daily in the morning.
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
- •Patients with open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator and who are currently on a stable treatment of IOP-lowering medication
排除标准
- •VA not worse than 0.60
- •additional clinically relevant ocular or systemic conditions may be excluded
研究组 & 干预措施
DuoTrav APS
Experimental
DuoTrav APS QD AM
干预措施: DuoTrav APS (Drug)
DuoTrav
Active Comparator
DuoTrav QD AM
干预措施: DuoTrav (Drug)
结局指标
主要结局
Mean Intraocular Pressure (IOP)
时间窗: 3 Months
次要结局
未报告次要终点
研究者
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