Safety and Efficacy of Using the Travoprost/Timolol Fixed Combination (DuoTrav®) in Patients With Open-Angle Glaucoma or Uncontrolled Ocular Hypertension by Beta-blocker Monotherapy (Timolol 0.5%)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy)
研究概览
简要总结
The purpose of this study was to assess the safety and intraocular pressure (IOP)-lowering efficacy of changing to DuoTrav® from prior timolol 0.5% monotherapy in participants 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
- •Clinical diagnosis of ocular hypertension, primary open-angle glaucoma or pigmentary glaucoma;
- •Intraocular pressure (IOP) of between 19 to 35 mmHg at any time of the day in at least one eye (designated as the study eye);
- •On a stable medication regimen for IOP reduction one week prior to the screening visit;
- •Best corrected visual acuity better than 20/200 (Snellen) or 1.0 (logMAR) in each eye;
- •Sign informed consent;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Known medical history of allergy, hypersensitivity or low tolerance to any of the components of DuoTrav®;
- •Any abnormality that would preclude the reliable performance of applanation tonometry in either eye;
- •Infection in either eye;
- •Conventional or laser intraocular surgery in either eye 3 months prior to screening visit;
- •Risk for visual field or visual acuity worsening, in the opinion of the investigator;
- •Women of childbearing potential;
- •Pregnant or lactating women;
- •Any condition that, in the opinion of the principal investigator, could interfere with participation in the study, or that could present a risk to the participant.
- •Participation in another clinical study within 30 days before the screening visit;
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
DuoTrav
Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
干预措施: Travoprost 0.004%/timolol maleate 0.5% fixed combination (Drug)
结局指标
主要结局
Mean Intraocular Pressure (IOP) Change at the Final Visit From Baseline (Prior Beta-blocker Monotherapy)
时间窗: Baseline, up to 6 weeks
As measured by Goldmann applanation tonometry. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement.
次要结局
未报告次要终点