NCT02623738已完成2 期
A Phase II/III Randomized, Double-masked, Controlled, Parallel Group, Multicenter Study Assessing the Efficacy and Safety of DE-117 Ophthalmic Solution in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension -AYAME Study-
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
- 253
- 主要终点
- Intraocular pressure
研究概览
简要总结
The purposes of this study are to determine the optimal concentration of DE-117 ophthalmic solution compared to the placebo ophthalmic solution and to determine if intraocular pressure reduction after 4 weeks of treatment with DE-117 ophthalmic solution is non-inferior to latanoprost ophthalmic solution 0.005%.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary open angle glaucoma or ocular hypertension
排除标准
- •Patients at risk of progression of visual field loss
- •Patients with severe visual field defect
- •Patients with any diseases that preclude participation in this study for safety reasons
研究组 & 干预措施
Placebo ophthalmic solution
Placebo Comparator
Eyedrop
干预措施: Placebo ophthalmic solution (Drug)
DE-117 ophthalmic solution low
Experimental
Eyedrop
干预措施: DE-117 ophthalmic solution low (Drug)
DE-117 ophthalmic solution high
Experimental
Eyedrop
干预措施: DE-117 ophthalmic solution high (Drug)
Latanoprost ophthalmic solution 0.005%
Active Comparator
Eyedrop
干预措施: Latanoprost ophthalmic solution 0.005% (Drug)
结局指标
主要结局
Intraocular pressure
时间窗: Week 4
次要结局
未报告次要终点
研究者
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