NCT02822729已完成3 期
A Long-term Open-label Study of DE-117 Ophthalmic Solution Monotherapy and Concomitant Use of DE-117 Ophthalmic Solution With Timolol Ophthalmic Solution in Patients With Open-angle Glaucoma or Ocular Hypertension : RENGE 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
- 125
- 主要终点
- Evaluation of adverse events
研究概览
简要总结
The purposes of this study are to evaluate the long-term safety and intraocular pressure-lowering efficacy of DE-117 ophthalmic solution monotherapy and concomitant use of DE-117 ophthalmic solution with timolol ophthalmic solution 0.5% in patients 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
- None
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
- •Patients with 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
DE-117 ophthalmic solution (Group1)
Experimental
Monotherapy
干预措施: DE-117 ophthalmic solution (Drug)
DE-117 ophthalmic solution (Group2)
Experimental
Monotherapy
干预措施: DE-117 ophthalmic solution (Drug)
DE-117 ophthalmic solution + Timolol (Group3)
Other
Concomitant Use
干预措施: DE-117 ophthalmic solution (Drug)
DE-117 ophthalmic solution + Timolol (Group3)
Other
Concomitant Use
干预措施: Timolol ophthalmic solution (Drug)
结局指标
主要结局
Evaluation of adverse events
时间窗: Week 52
次要结局
未报告次要终点
研究者
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