NCT00638742已完成1 期
A Phase 1, Open-Label Study of Latanoprost Acid Plasma Concentrations in Pediatric and Adult Glaucoma Patients Treated With Latanoprost 0.005%.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2008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
- 47
- 试验地点
- 1
- 主要终点
- Plasma latanoprost acid concentrations at steady-state.
研究概览
简要总结
To evaluate the steady-state systemic plasma concentrations of latanoprost acid following administration of latanoprost 0.005% (1.5 ug) in pediatric and adult subjects with glaucoma or ocular hypertension.
详细描述
Pharmacokinetics and Safety
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •This study will enroll pediatric and adult subjects with glaucoma or ocular hypertension receiving treatment with latanoprost in either one or both eyes for at least two weeks.
- •The pediatric subjects will be grouped by age (0 to <3 years, 3 to <12 years, 12 to 18 years).
排除标准
- •Ocular inflammation/infection or a history of ocular inflammation/infection within 3 months prior to the screening visit.
- •History of ocular trauma or surgery in either eye within 14-days of the screening visit.
- •Use of continuous wear contact lenses.
研究组 & 干预措施
1
Experimental
干预措施: latanoprost (Drug)
结局指标
主要结局
Plasma latanoprost acid concentrations at steady-state.
时间窗: 2 weeks
次要结局
- Adverse events related to systemic exposure of latanoprost(1 Day)
研究者
研究点 (1)
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