TO COMPARE THE THERAPEUTIC EFFICACY OF 0.004 PERCENT TRA VOPROST IN COMBINATION WITH 0.02 PERCENT NETARSUDIL VS 0.004 PERCENT TRA VOPROST IN COMBINATION WITH 0.5 PERCENT TIMOLOL IN PATIENTS WITH PRIMARY OPEN ANGLE GLAUCOMA
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- To compare the reduction in mean IOP with the use of 0.004 percent Travoprost in combination with 0.02
研究概览
简要总结
This single-blind randomized controlled trial aims to compare the intraocular pressure-lowering efficacy and safety of topical netarsudil and timolol in patients with primary open-angle glaucoma (POAG) who have inadequate response to travoprost monotherapy. Eligible patients will be randomized to receive either netarsudil or timolol in addition to travoprost, with follow-up assessments of intraocular pressure, ocular side effects, and patient tolerability over a defined study period. The study is designed to provide evidence on the optimal second-line therapy for POAG, ensuring patient safety and scientific validity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1Old and new Eligible candidates with bilateral open angle glaucoma diagnosed on GAT, gonioscopy, fundus examination and visual field defects.
- •All the previous anti-glaucoma drugs will be stopped for 3-4 weeks.
- •OCT will be performed on a baseline basis and after 6 months.
- •2 Age greater than or equal to 18 years 3 Unmedicated IOP greater than 20 mm Hg and less than 36 mm Hg in both eyes despite treatment with Travoprost monotherapy for at least 6 weeks 4On Travoprost as a first line therapy for POAG, but showing insufficient IOP control and visual field deterioration.
- •5BCV A of 20/200 or better in at least 1 eye.
- •6Able to comply with general study requireme.
排除标准
- •1History of narrow angles or iridocorneal angle closure.
- •2Congenital glaucoma 3Previous refractive surgery 4Any active ocular inflammation or infection.
- •5Clinically significant dry eye syndrome that could interfere with IOP measurement or treatmentadherence.
- •6Central corneal thickness greater than 620 microns 7Known hypersensitivity or contraindications to Netarsudil or latanoprost (or their excipients).
- •8Other ocular diseases that might interfere with the study 9Use of systemic or ocular medications which can alter IOP within the past 4 weeks.
- •10Pregnant or lactating women.
- •11Participation in another clinical trial involving investigational drugs or devices within the past 30 days.
结局指标
主要结局
To compare the reduction in mean IOP with the use of 0.004 percent Travoprost in combination with 0.02
时间窗: Baseline, 1 month, 3 months
percent Netarsudil v/s 0.004 percent Travoprost in combination with 0.5 percent timolol in patients with
时间窗: Baseline, 1 month, 3 months
primary open angle glaucoma.
时间窗: Baseline, 1 month, 3 months
次要结局
- The safety profile of 0.004 percent Travoprost in combination with 0.02 percent Netarsudil v/s 0.004 percent(Travoprost in combination with 0.5 percent timolol in patients with primary open angle glaucoma.)
研究者
Dr Vinod Sharma
IGMC Shimla