NCT05397600已完成3 期
Efficacy and Safety Assessment of T4032 (Unpreserved Bimatoprost 0.01%) Versus Lumigan® 0.01% 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
- 684
- 试验地点
- 63
- 主要终点
- Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP.
研究概览
简要总结
The main study purpose is to demonstrate the non-inferiority of T4032 compared to Lumigan® 0.01% in terms of efficacy.
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 dated and signed.
- •Both eyes diagnosed open-angle glaucoma or ocular hypertension
排除标准
- •History of trauma, infection, clinically significant inflammation within the previous 3 months
- •Known or suspected hypersensitivity to one of the components of the Investigational Medicinal Product(s)
- •Pregnancy or breast-feeding
研究组 & 干预措施
T4032
Experimental
干预措施: Bimatoprost Ophthalmic (Drug)
Lumigan
Active Comparator
干预措施: Bimatoprost Ophthalmic (Drug)
结局指标
主要结局
Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP.
时间窗: up to Week12
Change from baseline (Day 1) to Week 2, Week 6, and Week 12 in IOP at three time points (8:00 a.m.; 10:00 a.m.; 4:00 p.m.) in the study eye.
次要结局
未报告次要终点
研究者
研究点 (63)
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