NCT01123785已完成1 期
A Phase I/II Multi-Center, Randomized, Double-Masked, Placebo-Controlled, Dose-Escalation Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics (Efficacy) of Chronic Twice-Daily Topical Monocular Application of INO-8875 Ophthalmic Formulation in Adults With Ocular Hypertension or Primary Open-Angle Glaucoma
Inotek Pharmaceuticals Corporation1 个研究点 分布在 1 个国家目标入组 144 人开始时间: 2010年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
研究概览
简要总结
The purpose of this study is to evaluate how tolerable, safe, and effective it is to give INO-8875 eye drops to adults with 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has the diagnosis of ocular hypertension (OHT) or primary open-angle glaucoma (POAG).
- •Aged 18 to 75 years.
- •Mean intraocular pressure (IOP) of ≥24 and ≤34 mm Hg.
排除标准
- •No significant visual field loss or any new field loss within the past year.
- •Cup-to-disc ratio ≥0.8
- •Central corneal thickness <500 µm or >600 µm
- •History of adult asthma or chronic obstructive pulmonary disease
- •A recent (acute) or chronic medical condition that might obfuscate the Subject's study data
研究组 & 干预措施
Control
Placebo Comparator
Matched vehicle-control
干预措施: Placebo (Drug)
INO-8875
Experimental
Adenosine agonist eye drop
干预措施: INO-8875 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 14 days
次要结局
- Number of Participants with decreased Intra-ocular pressure(14 days)
研究者
研究点 (1)
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