NCT01494753已完成2 期
Pharmacokinetics, Efficacy and Safety Assessment of T2345 Compared With Active Comparator in Newly Diagnosed Patients With Open-angle Glaucoma or Ocular Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Mean Intra Ocular Pressure (IOP) at 8.00am
研究概览
简要总结
The purpose of this study is to assess the pharmacokinetics, efficacy and safety of T2345 versus an active comparator.
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
- Single (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
- •Untreated bilateral newly diagnosed patients with primary open angle glaucoma
排除标准
- •Any ocular hypertension other than chronic open angle glaucoma
研究组 & 干预措施
Prostaglandin
Active Comparator
One drop.
干预措施: Prostaglandin (Drug)
T2345
Experimental
One drop
干预措施: T2345 (Drug)
结局指标
主要结局
Mean Intra Ocular Pressure (IOP) at 8.00am
时间窗: Day 42 and Day 84 (8.00am for the IOP)
Efficacy criteria at 8.00am on Day 42 and on Day84. Worse Eye= the eligible eye (with at least one out of the 4 individual IOP values on Day 0 \>= 22 and \<=30mmHg) with the highest individual IOP at 8.00am on Day 0. If both eyes are eligible and have the same individual IOP at 8.00am on Day 0, the right eye is considered.
次要结局
未报告次要终点
研究者
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