NCT02981446已完成3 期
A Phase III, Randomized, Observer-Masked, Active-Controlled, Parallel-Group, Multinational and Multicenter Study Assessing the Safety and Efficacy of DE-117 Ophthalmic Solution 0.002% Compared With Latanoprost Ophthalmic Solution 0.005% in Subjects With Open-Angle Glaucoma or Ocular Hypertension- PEONY Study
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
- 370
- 主要终点
- Mean Diurnal IOP at Month 3
研究概览
简要总结
The purpose of this study is to investigate the intraocular pressure-lowering effect and the safety of DE-117 ophthalmic solution compared with Latanoprost ophthalmic solution in subjects with open angle glaucoma or ocular hypertension.
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
- •Patients with open angle glaucoma or ocular hypertension in both eyes
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
DE-117 ophthalmic solution
Experimental
干预措施: DE-117 (Drug)
Latanoprost ophthalmic solution 0.005%
Active Comparator
干预措施: Latanoprost ophthalmic solution (Drug)
结局指标
主要结局
Mean Diurnal IOP at Month 3
时间窗: Month 3 (average of IOP at 3 time points: 09:00, 13:00, 17:00)
The IOP (mmHg) measured in the study eye (identified at Day 1 \[baseline\]) was the efficacy measure for this study. The IOP was measured using a calibrated Goldmann applanation tonometer preferably by the same Investigator (operator) and the same authorized study staff (recorder) during the study for each subject.
次要结局
- IOP at 9 Timepoints (First Key Secondary Efficacy Endpoint)(09:00, 13:00, and 17:00 at Week 1, Week 6, and Month 3.)
- Mean Diurnal IOP at Week 1 (Second Key Secondary Endpoint)(Week 1)
研究者
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