NCT02105272已完成3 期
Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
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
- 237
- 主要终点
- Decrease From Baseline in Intraocular Pressure
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic solution in comparison with latanoprost ophthalmic solution in subjects who are insufficiently responsive to latanoprost ophthalmic solution.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with diagnosis of bilateral primary open-angle glaucoma or ocular hypertension
排除标准
- •Subjects with ocular conditions as defined by the protocol
研究组 & 干预措施
OPC-1085EL ophthalmic solution
Experimental
Once daily
干预措施: OPC-1085EL ophthalmic solution (Drug)
Latanoprost ophthalmic solution
Active Comparator
Once daily
干预措施: Latanoprost ophthalmic solution (Drug)
结局指标
主要结局
Decrease From Baseline in Intraocular Pressure
时间窗: Baseline, week 8 predose
次要结局
- Intraocular Pressure at Week 8 Predose(Week 8 Predose)
- Intraocular Pressure at Week 8 at 2 Hours After IMP Administration(Week 8 at 2 hours after IMP administration)
- Decrease From Baseline in Intraocular Pressure at Week 8 at 2 Hours After IMP Administration(Baseline, Week 8 at 2 hours after IMP administration)
- Intraocular Pressure at Week 8 at 8 Hours After IMP Administration(Week 8 at 8 hours after IMP administration)
- Decrease From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration(Baseline, Week 8 at 8 hours after IMP administration)
研究者
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