NCT00650338已完成2 期
A Randomized, Double-masked, Placebo- and Active- Controlled, Parallel-group, Multi-center, Dose-response Trial of DE-104 Ophthalmic Solution in Subjects With Primary Open-angle Glaucoma or Ocular Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Santen Inc.
- 入组人数
- 165
- 试验地点
- 14
- 主要终点
- To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP)
研究概览
简要总结
To investigate the dose-response relationship of DE-104 ophthalmic solution in lowering intraocular pressure (IOP) 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
- 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
- •Provided signed, written informed consent.
- •Diagnosed with primary open-angle glaucoma or ocular hypertension.
- •18 years of age and older.
- •If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study.
排除标准
- •Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception.
- •Presence of any abnormality or significant illness that could be expected to interfere with the study.
研究组 & 干预措施
1
Experimental
<described in intervention>
干预措施: DE-104 ophthalmic solution, low concentration (Drug)
2
Experimental
<described in intervention>
干预措施: DE-104 ophthalmic solution, medium concentration (Drug)
3
Experimental
<described in intervention>
干预措施: DE-104 ophthalmic solution, high concentration (Drug)
4
Placebo Comparator
<described in intervention>
干预措施: Placebo (Drug)
5
Active Comparator
<described intervention>
干预措施: 0.005% latanoprost (Drug)
结局指标
主要结局
To investigate the dose-response relationship of DE-104 in lowering intraocular pressure (IOP)
时间窗: 28 days
次要结局
- To compare the safety and efficacy of DE-104 ophthalmic solution with placebo and 0.005% latanoprost.(35 days)
研究者
研究点 (14)
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