An Investigator-Masked, Dose-Escalation Study to Determine the Safety, Tolerability, Pharmacokinetics, and Efficacy of OPA-6566 Ophthalmic Solution in Subjects With Primary Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 主要终点
- Safety: incidence of treatment emergent adverse events (TEAEs), vital signs, physical exam, ocular exams, electrocardiogram, ocular symptoms, laboratory tests on whole blood, serum and urine.
研究概览
简要总结
This is a study of the safety, tolerability, pharmacokinetics (measurement of drug levels in the blood), and intraocular pressure lowering effects of OPA-6566 ophthalmic solution in subjects with primary 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of bilateral primary open-angle glaucoma
- •diagnosis of ocular hypertension as defined in the protocol
排除标准
- •any form of glaucoma other than primary open-angle glaucoma in either eye
- •other ocular conditions as defined by the protocol
研究组 & 干预措施
OPA-6566 low dose
Treatment with OPA-6566 low dose
干预措施: OPA-6566 (Drug)
OPA-6566 medium dose
Treatment with OPA-6566 medium dose
干预措施: OPA-6566 (Drug)
OPA-6566 high dose
Treatment with OPA-6566 high dose
干预措施: OPA-6566 (Drug)
Latanoprost
Treatment with Latanoprost
干预措施: Latanoprost (Drug)
Placebo
Placebo
干预措施: Placebo (Drug)
OPA-6566 additional dose
Treatment with OPA-6566 additional dose
干预措施: OPA-6566 (Drug)
结局指标
主要结局
Safety: incidence of treatment emergent adverse events (TEAEs), vital signs, physical exam, ocular exams, electrocardiogram, ocular symptoms, laboratory tests on whole blood, serum and urine.
时间窗: 28 days of treatment: visit 1 (screening), visit 2 (eligibility), visit 3 (randomization) visit 4 (Day 14), visit 5 (Day 28)
次要结局
- Composite of Pharmacokinetics(28 days: visit 3 (randomization); visit 4 (Day 14) ; visit 5 (Day 28))
- Efficacy: measurement of change in intraocular pressure from baseline.(28 days: visit 1 (screening); visit 2 (eligibility) ; visit 3 (randomization) , visit 4 (Day 14) ; visit 5 (Day 28))