A Phase 1/2 Safety and Efficacy Study of JV-GL1 Applied to the Periorbital Skin in Subjects With Open-Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Intraocular Pressure (IOP)
研究概览
简要总结
The aim of this research study is to assess the safety and feasibility of lowering intraocular pressure (IOP) using an experimental study drug, JV-GL1.
详细描述
This is an open-label, dose escalation and dose expansion, study in adult participants with open-angle glaucoma or ocular hypertension. The study is divided into 2 parts:
Part 1 of the study is a dose escalation, sequentially testing escalating doses of JV-GL1.
Part 2 of the study will be randomized 2:2:1 (Experimental Dose A: Experimental Dose B: Active Control), treating additional subjects at the selected JV-GL1 doses or Latanoprost 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
- None
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
- •bilateral open-angle glaucoma or ocular hypertension
排除标准
- 未提供
研究组 & 干预措施
Randomized Part 2, Arm 1
Dose 1 selected in Part I
干预措施: JV-GL1 (Drug)
Randomized Part 2, Arm 2
Dose 2 selected in Part I
干预措施: JV-GL1 (Drug)
Randomized Part 2, Arm 3
干预措施: Latanoprost 0.005% Ophthalmic Solution (Drug)
结局指标
主要结局
Intraocular Pressure (IOP)
时间窗: From Baseline to Day 28 of Treatment
Change from baseline in Intraocular Pressure (IOP)
次要结局
未报告次要终点