Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 193
- 主要终点
- Decrease From Baseline in Intraocular Pressure at Week 8 Predose
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 carteolol long-acting ophthalmic solution in subjects who are insufficiently responsive to carteolol long-acting 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
Once daily
干预措施: OPC-1085EL ophthalmic solution (Drug)
Carteolol long-acting ophthalmic solution
Once daily
干预措施: Carteolol long-acting ophthalmic solution (Drug)
结局指标
主要结局
Decrease From Baseline in Intraocular Pressure at Week 8 Predose
时间窗: Baseline, Week 8 Predose
Comparison of each group in change from baseline in intraocular pressure. Arm of "a treatment group coming together with latanoprost / carteolol" is a reference group． As for "Primary Outcome" and "Secondary Outcome" analysis , the OPC-1085EL group was compared only to the carteolol group, not to the latanoprost/carteolol concomitant group.
次要结局
- Intraocular Pressure at Week 8 at 8 Hours After IMP Administration(Week 8 at 8 hours after IMP administration)
- Intraocular Pressure at Week 8 at 2 Hours After IMP Administration(Week 8 at 2 hours after IMP administration)
- Intraocular Pressure at Week 8 Predose(Week 8 Predose)
- Change From Baseline in Intraocular Pressure at Week 8 at 8 Hours After IMP Administration(Baseline, Week 8 at 8 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)