A Phase I/II, Randomized, Observer-masked, Placebo-and Active-controlled, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of DE-117 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
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in intraocular pressure (IOP) on Day 29 at each scheduled time point
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of up to three concentrations of DE-117 ophthalmic solution (Low Dose, Medium Dose, and High Dose) as monotherapy and as adjunctive therapy (DE-117 ophthalmic solution with 0.0015% tafluprost) in subjects with primary open-angle glaucoma or ocular hypertension.
详细描述
This is a two stage study.
Stage One will explore the dose response of three concentrations of DE-117 as monotherapy compared with 0.0015% tafluprost and placebo. The safety and efficacy of DE-117 as adjunctive therapy (with 0.0015% tafluprost) compared with 0.0015% tafluprost and placebo will also be evaluated. In addition, the additive effect of adjunctive therapy of each concentration will be compared with the corresponding monotherapy concentration.
Stage Two will assess the safety and efficacy of the optimal DE-117 concentration as monotherapy compared with 0.0015% tafluprost. The safety and efficacy of the optimal DE-117 concentration as adjunctive therapy (with 0.0015% tafluprost) compared with DE-117 monotherapy and 0.0015% tafluprost will also be evaluated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, 18 years of age or older
- •Current diagnosis of primary open-angle glaucoma or ocular hypertension in both eyes
- •Qualifying intraocular pressure (IOP) in at least one eye at Baseline
排除标准
- •Closed/barely open anterior chamber angle or a history of acute angle closure in either eye
- •Anticipate the need to initiate or modify medication (systemic or topical) that is known to affect intraocular pressure (IOP) during the study period
- •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
Low Dose DE-117 and 0.0015% tafluprost
Adjunctive Therapy
干预措施: DE-117 and 0.0015% tafluprost (Drug)
Med. Dose DE-117 and 0.0015% tafluprost
Adjunctive Therapy
干预措施: DE-117 and 0.0015% tafluprost (Drug)
Low Dose DE-117
Monotherapy
干预措施: DE-117 (Drug)
Medium Dose DE-117
Monotherapy
干预措施: DE-117 (Drug)
High Dose DE-117
Monotherapy
干预措施: DE-117 (Drug)
High Dose DE-117 and 0.0015% tafluprost
Adjunctive Therapy
干预措施: DE-117 and 0.0015% tafluprost (Drug)
0.0015% tafluprost
Monotherapy
干预措施: 0.0015% tafluprost (Drug)
Placebo
Monotherapy
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in intraocular pressure (IOP) on Day 29 at each scheduled time point
时间窗: Day 28 T0 (08:00 ±30 mins), T0+2 hrs, T0+4 hrs, T0+8 hrs
次要结局
未报告次要终点