To Assess the Safety and Efficacy of Travacom in Patients With Uncontrolled Intraocular Pressure
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 468
- 试验地点
- 1
- 主要终点
- Primary efficacy: Change in IOP at the final visit from prior beta-blocker monotherapy (Timolol 0.5% only)
研究概览
简要总结
This study is a multi-site, unmasked phase IV study. Travacom(R) is a combination topical ocular agent, containing travoprost and timolol, which lower intraocular pressure (IOP) by complementary mechanisms of action. The safety and efficacy of both travoprost and timolol have been established as single and adjunctive therapy in well-controlled clinical studies in thousands of patients diagnosed with open angle glaucoma (OAG) or ocular hypertension. The objective of this study is to assess the safety and efficacy of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension across India.
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
- •Must have a clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
- •Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
- •Must be able to follow instructions and be willing and able to attend all study visits.
排除标准
- •A known medical history of allergy, hypersensitivity or poor tolerance to any component of Travacom that is deemed clinically significant in the opinion of the Principle Investigator.
- •Any abnormality preventing reliable applanation tonometer in either eye. Corneal dystrophies.
- •Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber of either eye.
研究组 & 干预措施
Travacom
Travacom ophthalmic solution
干预措施: Travacom (Drug)
结局指标
主要结局
Primary efficacy: Change in IOP at the final visit from prior beta-blocker monotherapy (Timolol 0.5% only)
时间窗: Baseline to Visit 3 (Week 6-8)
To assess the efficacy of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension.
Safety: Adverse Events.
时间窗: Baseline to Visit 3 (Week 6-8)
To assess the safety of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension.
Secondary efficacy: Percentage of subjects at target IOP (</ 18 mmHg), regardless of prior therapy.
时间窗: Baseline to Visit 3 (Week 6-8)
To assess the efficacy of changing to Travacom from prior pharmacotherapy in uncontrolled patients with open-angled glaucoma or ocular hypertension.
次要结局
未报告次要终点