CTRI/2018/04/013091已完成3 期
A Comparative, Randomized, Two Arm, Double Blind, Parallel group, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Ripasudil Hydrochloride Hydrate Eye Drops 0.4% w/v Vs Timolol Maleate Eye Drops 0.5% w/v in Subjects Suffering from Ocular Hypertension / Glaucoma.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 240
- 试验地点
- 19
- 主要终点
- Mean reduction in the IOP from baseline to end of study visit.
研究概览
简要总结
This is Comparative, Randomized, Two Arm, Double Blind, Parallel group, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Ripasudil Hydrochloride Hydrate Eye Drops 0.4% w/v Vs Timolol Maleate Eye Drops 0.5% w/v in Subjects Suffering from Ocular Hypertension / Glaucoma. The Primary Outcome of the study is Mean reduction in the IOP from baseline to end of study visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects with IOP between 22mm Hg – 30mm Hg at the time of screening in any one eye.
- •Incase both the eyes of a single subject are affected then the eye fulfilling the criteria will be considered for the evaluations.
- •If both eyes are fulfilling the criteria, then the right eye will be considered for the study.
- •2.Voluntary willingness of patient to give written informed consent prior to participation in trial.
排除标准
- •1.Women who are not using an effective means of contraception or who are pregnant or nursing.
- •2.Subjects with any severe or advanced cases of Glaucoma 3.Shaffer angle grade < 2 in either eye (range, 0 [complete or partial closure] to 3 [wide open angle, > 20]), as measured by Gonioscopy.
- •4.Subjects who are blind or subjects who have a single eye.
- •5.Severe central visual field loss in either eye measured by Perimetry.
- •6.Cup/disc ratio greater than 0.
- •7.Subject who are schedule to undergo surgery of the eye during the study period.
- •8.History of/current chronic, recurrent or severe inflammatory eye disease (eg: scleritis, uveitis, herpes keratitis) or current other severe ocular pathology (including severe dry eye) that would affect the conduct of the study.
- •9.History of ocular trauma or any other intraocular surgery within the past 6 months in either eye.
- •10.Current/history of ocular infection or inflammation within the past 3 months as determined by patient history and/or eye examination.
结局指标
主要结局
Mean reduction in the IOP from baseline to end of study visit.
时间窗: Day 0 and Day 90
次要结局
- Mean reduction in the phasing of IOP from baseline to end of study visit.(Day 0 and Day 90)
研究者
研究点 (19)
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