NCT04898387已完成3 期
Efficacy and Safety Assessment of T4030 Eye Drops Versus Ganfort® UD in Ocular Hypertensive or Glaucomatous Patients.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 554
- 试验地点
- 1
- 主要终点
- IOP assessment
研究概览
简要总结
To demonstrate the non-inferiority of T4030 unpreserved eye drops compared to Ganfort® UD in terms of efficacy.
详细描述
Efficacy Parameters IOP assessment in each eye
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)
盲法说明
The 2 different treatment kits should be identical in external packaging in order to respect the masked evaluation for efficacy and safety.
The identity of the IMP given to each patient will not be known by the masked 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*
- •Patient aged ≥18 years old
- •Both eyes with a central corneal thickness assessment ≥500 µm and ≤600 μm a
- •Both eyes with diagnosed ocular hypertension or open angle glaucoma
排除标准
- •History of narrow angle and/or angle closure glaucoma
- •Advanced stage of glaucoma
结局指标
主要结局
IOP assessment
时间窗: Week 12
The primary efficacy endpoint is the change from Baseline (Day 1) to Week 12 in IOP
次要结局
- Ocular Sign(Week 6 Week 12)
研究者
研究点 (1)
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