Comparative Efficacy and Safety of Topical Eye Drops Travoprost 0.004 percent Versus Timolol 0.5 percent in Patients with Primary Open Angle Glaucoma in a Tertiary Care Teaching Hospital A Prospective Open Label Parallel Group Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- difference of reduction in mean intraocular pressure in patients with Primary Open Angle Glaucoma receiving Travoprost 0.004% and Timolol 0.5 % eye drops from baseline at the end of 12 weeks
研究概览
简要总结
This study aims to compare the efficacy and safety of Travoprost 0.004% and Timolol 0.5% eye drops in patients with Primary Open-Angle Glaucoma (POAG). It is a prospective, open-label, parallel-group study which will be conducted at a tertiary care teaching hospital over 12 weeks. The primary objective is to assess the reduction in intraocular pressure (IOP), while secondary objectives include evaluating safety (adverse drug reactions) and medication adherence using a validated scale. Forty-two patients meeting inclusion criteria will be randomized into two groups. Travoprost is hypothesized to demonstrate superior efficacy, safety, and adherence compared to Timolol, which will be analysed in this study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged ≥ 40 years of either gender
- •Best corrected visual acuity ≥ 6 / 60
- •Newly diagnosed patients of primary open-angle glaucoma with mean intraocular pressure (IOP) of 24-36 mm Hg in at least one eye
- •Subjects willing to give written informed consent.
排除标准
- 未提供
结局指标
主要结局
difference of reduction in mean intraocular pressure in patients with Primary Open Angle Glaucoma receiving Travoprost 0.004% and Timolol 0.5 % eye drops from baseline at the end of 12 weeks
时间窗: from baseline at the end of 12 weeks
次要结局
- 1.Incidence of adverse events reported by patients with Primary Open Angle Glaucoma receiving Travoprost 0.004% and timolol 0.5 % eye drops from baseline at the end of 12 weeks(2.Assessment of medication adherence – comparison of medication adherence to study drug will be done by medication adherence reporting scale (MARS-10))
研究者
DR RITU RUCHI KERKETTA
GMC NAGPUR