A Phase I/II Dose Escalation Safety and Efficacy Trial of DE-112 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
- Santen Inc.
- 入组人数
- 147
- 主要终点
- Intraocular pressure (IOP)
研究概览
简要总结
To investigate the safety and efficacy of DE-112 in lowering intraocular pressure in subjects with primary open-angle glaucoma or ocular hypertension.
详细描述
This study will be conducted in two stages. Stage One is an open-label, adaptive dose-selection, safety and efficacy trial of up to four concentrations of DE-112 ophthalmic solution enrolling a total of 24 subjects.
Stage Two of the study is a randomized, double-masked, placebo- and active-controlled, parallel-group, multi-center trial comparing the efficacy and safety of two concentrations of DE-112 ophthalmic solution with placebo and timolol enrolling a total of 120 subjects.
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
- •Provide signed, written informed consent
- •18 yeas of age and older
- •Diagnosed with primary open-angle glaucoma or ocular hypertension
- •Female subject of childbearing potential must utilize reliable contraceptive throughout the study and have a negative urine pregnancy test prior to enrollment into this study
- •Meet specific Visit 2, Day 0 (Baseline)criteria at baseline
排除标准
- •Females who are pregnant, nursing or planning a pregnancy
- •Presence of any abnormality or significant illness that could be expected to interfere with the study.
研究组 & 干预措施
Vehicle Solution
干预措施: DE-112 Vehicle Solution (Drug)
Concentration 4
干预措施: DE-112 (Drug)
Concentration 1
干预措施: DE-112 (Drug)
Concentration 2
干预措施: DE-112 (Drug)
Concentration 3
干预措施: DE-112 (Drug)
Timolol Maleate Ophthalmic Solution
干预措施: Timolol Maleate Solution (Drug)
结局指标
主要结局
Intraocular pressure (IOP)
时间窗: 29 days
Change from baseline in mean diurnal IOP
次要结局
- Intraocular pressure (IOP)(29 days)