NCT00515424已完成1 期
A Multicenter, Randomized, Placebo-Controlled, Latanoprost-Controlled, Parallel Group Study to Assess the Tolerability, Safety and Efficacy of RKI983 Ophthalmic Solution Given Twice a Day Over One Week in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 90
- 试验地点
- 5
- 主要终点
- Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, ECGs and vital signs over period of 7 days treatment.
研究概览
简要总结
This study will evaluate the tolerability and safety of RKI983 ophthalmic solution and explore the effect of the compound on intraocular pressure in subjects with 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
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
- •Males and females, ≥18 years of age, with primary open angle glaucoma and ocular hypertension
- •Females must be post-menopausal or surgically sterile
排除标准
- •Other types of glaucoma
- •Eye pressure lowering surgeries
- •A history of or current eye conditions or medical problems that would prohibit the use of an investigational drug
- •Other protocol-defined inclusion/exclusion criteria may apply.
结局指标
主要结局
Rates of adverse events and serious adverse events, as well as changes in ophthalmic evaluations, laboratory values, ECGs and vital signs over period of 7 days treatment.
次要结局
- Change in ocular hypertension from Baseline to Day 7.
研究者
研究点 (5)
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