A Phase 2b Randomized, Double-masked, Active-controlled, Dose-response Study of the Safety and Efficacy of H-1337 in Subjects With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 9
- 主要终点
- Efficacy as Assessed by Change in Intraocular Pressure
研究概览
简要总结
The trial will evaluate the safety and efficacy of 3 dose regimens of H-1337 [0.6% twice daily (b.i.d.), 1.0% b.i.d. and 1.0% once in the morning (q.a.m.), and timolol maleate (0.5%, b.i.d.) in both eyes for 28 days.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（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 or ocular hypertension
排除标准
- •Closed or very narrow angles (Grades 0-1) or those the investigator judges as occludable and/or with evidence of peripheral anterior synechiae >/= 180 degrees by gonioscopy within 6 months prior to screening visit in either eye
- •Note: Other inclusion/exclusion criteria apply.
研究组 & 干预措施
H-1337 0.6% Ophthalmic Solution b.i.d.
One drop H-1337 twice daily in the study eye for 28 days
干预措施: H-1337 0.6% (Drug)
H-1337 1.0% Ophthalmic Solution b.i.d.
One drop H-1337 twice daily in the study eye for 28 days
干预措施: H-1337 1.0% (Drug)
H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.
One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days
干预措施: H-1337 1.0% (Drug)
H-1337 1.0% Ophthalmic Solution q.a.m. and H-1337 Placebo q.p.m.
One drop H-1337 every morning and matching placebo every evening in the study eye for 28 days
干预措施: H-1337 Placebo (Drug)
Timolol 0.5% Ophthalmic Solution b.i.d.
One drop Timolol twice daily in the study eye for 28 days
干预措施: Timolol 0.5% (Drug)
结局指标
主要结局
Efficacy as Assessed by Change in Intraocular Pressure
时间窗: Day 28
Mean change in intraocular pressure from baseline on Day 28 compared to timolol
次要结局
- Efficacy as Assessed by Intraocular Pressure(Day 0, Day 1, Day 7, Day 14, and Day 28)
- Safety as Assessed by Adverse Event Reporting(Screening through Day 28)