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临床试验/CTRI/2022/09/045191
CTRI/2022/09/045191尚未招募不适用

Evaluation of intraocular pressure lowering effect of 0.4% Ripasudil eye drops in patients with primary open angle glaucoma and ocular hypertension

Sankara eye hospital1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2022年7月9日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
55
试验地点
1
主要终点
To study the intraocular pressure lowering effect of 0.4% Ripasudil eye drops in patients with primary open angle glaucoma and ocular hypertension

研究概览

简要总结

Glaucoma is a group of progressive optic neuropathy characterised by typical damage to the optic nerve head (cupping) and associated visual dysfunction. Glaucoma is the main cause of irreversible vision loss in adults worldwide. Glaucomatous damage to the optic nerve appears to be the final common pathway to a diverse assortment of etiologic factors and clinical subtypes. An increase of intraocular pressure (IOP) is the primary risk factor for the development and progression of glaucoma. Thus, the most effective treatment for glaucoma is the lowering of raised IOP. Topical antiglaucoma eye drops are used as the primary treatment for the reduction of IOP. Ripasudil hydrochloride hydrate is a rho-associated coiled - coil forming kinase (ROCK) inhibitor, which reduces IOP by enhancing conventional aqueous humor outflow via changes in the morphology of trabecular meshwork cells, inhibition of extracellular matrix production, and increased juxta - Schlemm canal permeability. Ripasudil eyedrops at 0.4% concentration can significantly lower IOP in patients with primary open angle glaucoma (POAG) and ocular hypertension (OHT). ROCK inhibitors can increase aqueous humor outflow and decrease IOP by targeting the cytoskeleton of the trabecular meshwork and Schlemm’s canal cells.

研究设计

研究类型
Interventional
分配方式
Not Applicable
盲法
Not Applicable

入排标准

年龄范围
18.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Patients with Central Corneal Thickness corrected intraocular pressure more than or equal to 22mmHg which includes primary open angle glaucoma and ocular hypertension.

排除标准

  • Patients with history of ocular trauma Patients with history of intraocular surgery Secondary glaucomas like angle closure glaucoma, neovascular glaucoma, pseudo-exfoliative glaucoma, pigmentary glaucoma Patients with pre-existing corneal diseases Pre-existing dry eye Patients with allergic conjunctivitis Pregnant and lactating women Patients who are not willing for follow up.

结局指标

主要结局

To study the intraocular pressure lowering effect of 0.4% Ripasudil eye drops in patients with primary open angle glaucoma and ocular hypertension

时间窗: Intraocular pressure is measured at baseline, 4 weeks, 12 weeks and 24 weeks

次要结局

  • To assess the requirement of additional ocular hypotensive drug in those patients on Ripasudil therapy(By comparing IOP at presentation (baseline) and at 1st month, 3rd months, 6th months)
  • To assess the IOP lowering effect of Ripasudil as a monotherapy or as an additive agent(By comparing IOP at presentation (baseline) and at 1st month, 3rd months, 6th months)
  • To assess the incidence of side effects with Ripasudil(By assessing the side effects at 1st month, 3rd month and 6th month)
  • To assess the requirement of additional lubricants to continue Ripasudil(By assessing the side effects at 1st month, 3rd month and 6th month)

研究者

申办方类型
Research institution and hospital

研究点 (1)

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