Comparative Clinical Study of The Safety And Efficacy of A New Fixed-Combination of Timolol-Brimonidine-Dorzolamide In Patients With Open Angle Glaucoma Or Ocular Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Intraocular Pressure (IOP)
研究概览
简要总结
To compare intraocular pressure lowering effectiveness of a new fixed combination drug.
详细描述
This is a multicentric, double blind and prospective clinical study. We will include patients with confirmed diagnosis of primary open-angle glaucoma and/or ocular hypertension, with intraocular pressure (IOP) ranging between 21 and 31 mm Hg. Patients will be randomly divided into 2 groups, one of them treated with a new formulation of 0.5% timolol-0.2% brimonidine-2% dorzolamide in fixed combination (Krytantek Ofteno®, Laboratorios Sophia, Mexico) and the other one treated with 0.5% timolol-2% dorzolamide fixed combination (Cosopt®, MSD Laboratories, USA). Patients will receive 1 drop twice a day of either formulations and were examined at days 2, 7, 15, 30, 60, and 90 after initiation of treatment. The primary objective is to compare the efficacy of both formulations, estimated as a decrease in IOP. A Goldmann applanation tonometer will be used for IOP determination.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 90 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension;
- •Visual acuity of 20/40 to 20/80 or better (Snellen equivalent).
排除标准
- •Clinically relevant ophthalmic or systemic conditions may be excluded.
研究组 & 干预措施
A
IOP Dorzolamide-Timolol-Brimonidine group
干预措施: dorzolamide-timolol-brimonidine (Drug)
B
IOP dorzolamide-timolol group
干预措施: dorzolamide-timolol-brimonidine (Drug)
结局指标
主要结局
Intraocular Pressure (IOP)
时间窗: basal (day 1 ) and final (day 60)
the intraocular pressure was measured by the Goldman tonometer and reported in millimeters of mercury.
次要结局
- Number of Adverse Events(basal (day 1 ) and security call (day 75))
