NCT00928590已完成3 期
A Twelve-Month Open-Label Safety Study of Polyquaternium-Preserved DuoTrav APS Dosed Once Daily in Patients With Open-Angle Glaucoma or Ocular Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 155
- 主要终点
- Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to describe the long-term safety of a fixed combination product containing an alternative preservative, dosed once daily for 12 months, in patients with open-angle glaucoma or ocular hypertension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Willing and able to sign an informed consent document.
- •Open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator.
- •Stable treatment of an IOP-lowering medication.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Pregnant, breastfeeding, or not using adequate birth control.
- •Best-corrected visual acuity (BCVA) worse than 55 ETDRS letters.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
DuoTrav APS
Experimental
Travoprost/Timolol Maleate Fixed Combination solution, 1 drop in the study eye(s) once daily, at 9 AM, for 12 months
干预措施: Travoprost/Timolol Maleate Fixed Combination solution (Drug)
结局指标
主要结局
Adverse Events (AEs)
时间窗: 12 months
次要结局
未报告次要终点
研究者
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