NCT01168414已完成3 期
A Randomized, Comparison of the Effects of Ganfort and Duotrav on Intraocular Pressure in Patients With Primary Open Angle Glaucoma or Ocular Hypertension Open Label/Evaluator-blind/Cross-over Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Mean intraocular pressure of the 12-hour IOP curve
研究概览
简要总结
This is a single-center, cross-over comparison parallel group randomized trial designed to evaluate the efficacy and safety of Ganfort compared to Duotrav for a treatment period of 8 weeks each.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Visual acuity 6/60 or better
- •Patients who are controlled (IOP < 21 mmHg) on non-fixed combination of Latanoprost & Timolol for at least 3 months before the baseline visit and
- •Patients on mono-therapy either Latanoprost or Timolol who are eligible for dual therapy being not satisfactorily controlled (IOP>21mmHG)
排除标准
- •Angle closure glaucoma
- •Neovascular Galucoma
- •Secondary open angle glaucoma
- •Ocular infection/inflammation within 3 months
- •Ocular surgery within 3 months
- •History of Refractive surgery
- •Argon laser trabeculoplasty/Selective laser trabeculoplasty
- •Pregnancy/nursing
- •Hypersensitivity to benzalkonium chloride or to any other components of the trial drugs solution.
- •Patients in whom beta-blockers are contraindicated
- •Patients on any drugs known to affect IOP.
研究组 & 干预措施
Ganfort
Active Comparator
Fixed combination of Bimatoprost and Timolol
干预措施: Ganfort (Drug)
Duotrav
Active Comparator
Fixed combination of Travoprost and Timolol
干预措施: Duotrav (Drug)
结局指标
主要结局
Mean intraocular pressure of the 12-hour IOP curve
时间窗: 8 weeks
To compare the mean intraocular pressure of the 12-hour IOP curve for Ganfort and Duotrav
次要结局
- Mean intraocular pressure(12 hours)
研究者
研究点 (1)
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