NCT03825380已完成3 期
Efficacy and Safety Assessment of T4032 Versus Lumigan® 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
- 485
- 试验地点
- 1
- 主要终点
- Intra-Ocular Pressure
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of T4032 versus Lumigan.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed and dated.
- •Both eyes with diagnosed open-angle glaucoma or ocular hypertension
排除标准
- •History of trauma, infection, clinically significant inflammation within the 3 previous months.
- •Uncontrolled diabetic patient.
- •Pregnancy or breast feeding.
研究组 & 干预措施
Lumigan®
Active Comparator
干预措施: Lumigan® (Drug)
T4032
Experimental
干预措施: Bimatoprost (Drug)
结局指标
主要结局
Intra-Ocular Pressure
时间窗: Week 12
Change from Baseline to Week 12 in Intra Ocular Pressure in mmHg in the worse eye
次要结局
未报告次要终点
研究者
研究点 (1)
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