A Randomized, Observer-masked Study of the Safety, Tolerability and Pharmacodynamics of Sequential Ascending 28-Day Repeated Topical Doses of SAR366234 Versus Latanoprost in Patients With Open Angle Glaucoma or Ocular Hypertension
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 54
- 试验地点
- 5
- 主要终点
- Number of adverse events (including local tolerance and ophthalmological examinations)
研究概览
简要总结
Primary Objective:
To assess the local and systemic safety and tolerability of ascending repeated topical doses of SAR366234 monotherapy in patients with open angle glaucoma (OAG) or ocular hypertension (OHT) as compared to latanoprost.
Secondary Objective:
To assess the pharmacodynamic activity of ascending repeated topical doses of SAR366234 in patients with OAG or OHT as compared to latanoprost.
详细描述
The total study duration for one patient is up to 11 weeks, including a screening period of up to 6 weeks run-in (depending on washout requirements), a 4-week treatment period, and a 1-week follow-up period.
The study design is also a parallel cohort study to assess the safety, tolerability, and pharmacodynamic activity of SAR366234.
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 (Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAR366234 (Dose 5)
A high dose of SAR366234 will be administered 2 drops per eye per day for 28 days
干预措施: SAR366234 (Drug)
SAR366234 (Dose 1)
A low dose of SAR366234 will be administered 2 drops per eye per day for 28 days
干预措施: SAR366234 (Drug)
SAR366234 (Dose 2)
A medium dose of SAR366234 will be administered 1 drop per eye per day for 28 days
干预措施: SAR366234 (Drug)
SAR366234 (Dose 3)
A medium dose of SAR366234 will be administered 2 drops per eye per day for 28 days
干预措施: SAR366234 (Drug)
SAR366234 (Dose 4)
A high dose of SAR366234 will be administered 1 drop per eye per day for 28 days
干预措施: SAR366234 (Drug)
Latanoprost
A dose of Latanoprost will be administered 1 drop per eye per day for 28 days
干预措施: Latanoprost (Drug)
结局指标
主要结局
Number of adverse events (including local tolerance and ophthalmological examinations)
时间窗: From screening (Day -42) up to approximately Day 39
次要结局
- Assessment of IOP using Goldman applanation tonometry(From screening (Day -42) up to approximately Day 39)