NCT01156012已完成3 期
Efficacy and Safety Assessment of T2345 in Ocular Hypertensive or Glaucomatous Patients
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
- 404
- 试验地点
- 1
- 主要终点
- Change From Baseline in Intraocular Pressure (IOP)
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of T2345 versus active comparator.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients diagnosed with glaucoma
排除标准
- •Under 18.
研究组 & 干预措施
T2345
Experimental
One drop of T2345
干预措施: T2345 (Drug)
Prostaglandin
Active Comparator
One drop
干预措施: Prostaglandin (Drug)
结局指标
主要结局
Change From Baseline in Intraocular Pressure (IOP)
时间窗: Day 0 and Day 84
The worse eye is defined as: * If both eyes are eligible the eye with highest Intraocular pressure (IOP) at Day 0 (D0). If both eyes have the same IOP at D0 the worse eye is the right eye. * If only one eye is eligible this eye is the worse eye. * If neither eye is eligible the worse eye is defined as the eye with the highest IOP at D0. If both eyes have the same IOP at D0 the worse eye is the right eye.
次要结局
未报告次要终点
研究者
研究点 (1)
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