A Phase III, Multi-center, Randomized, Single-blind (to Evaluator), Parallel, and Positive-controlled Clinical Trial Evaluating the Efficacy and Safety of OPC-1085EL Ophthalmic Solution in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Chinese Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- evaluate pre-dose intraocular pressure change from baseline to week 8
研究概览
简要总结
It is a phase III, multi-center, randomized, single-blind (to evaluator), parallel, and positive-controlled clinical trial evaluating the efficacy and safety of OPC-1085EL in the treatment of primary open angle glaucoma or ocular hypertension in Chinese subjects. It is planned that 240 subjects (120 in each group) will be randomly assigned to receive OPC-1085EL or 0.005% latanoprost ophthalmic solution (latanoprost) at a ratio of 1:1.
详细描述
The trial includes 2 period:
- Screening period: 4 weeks. For subjects entering the screening period, 0.005% latanoprost will be administered for 4 consecutive weeks, one drop for each eye, once per day.
- Evaluation period: 8 weeks. Subjects who are eligible are randomly assigned to the OPC-1085EL group or 0.005% latanoprost group at a ratio of 1:1, one drop for each eye, once per day.
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 (Participant)
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
- •Gender: Unlimited
- •Hospitalization status: Outpatients
- •Age: 20-80 years old
- •Subjects with both eyes diagnosed as primary open angle glaucoma or ocular hypertension.
- •[At the end of the screening period]
- •IOP: After 4 weeks treatment with 0.005% latanoprost, the unilateral eye with a pre-dose IOP from 18 mmHg to <30 mmHg, and IOP <30 mmHg in the contralateral eye.
排除标准
- •Subjects with a best-corrected visual acuity ≤ 0.
- •Subject with any secondary glaucoma such as exfoliative or pigmented glaucoma.
- •Subjects who cannot stop using contact lenses during the trial.
- •Subjects who are judged by investigators to be at risk when receiving carteolol hydrochloride or 0.005% latanoprost as monotherapy.
- •Subjects who are allergic to any ingredients in carteolol or latanoprost.
研究组 & 干预措施
subject receive 0.005% latanoprost ophthalmic solution
0.005% latanoprost ophthalmic solution group ，one drop for each eye, once per day for 8 weeks
干预措施: 0.005% Latanoprost (Drug)
subject receive OPC-1085EL solution
OPC-1085EL group ，one drop for each eye, once per day for 8 weeks
干预措施: OPC-1085EL (Drug)
结局指标
主要结局
evaluate pre-dose intraocular pressure change from baseline to week 8
时间窗: baseline；week 8
Baseline intraocular pressure: The pre-dose and 2 hours after dosing intraocular pressures measured
次要结局
- intraocular pressure change from baseline(Week 4；Week 8)
- intraocular pressure change rate from baseline(week 4:)
- intraocular pressure(Week 4；Week 8:)
- Safety evaluation variable：adverse event(from screening period to evaluation period, assessed up to 3 weeks.)