A Clinical trial to check the effect, Safety and Tolerability of Ripasudil Hydrochloride Hydrate Eye Drops 0.4% w/v Vs Timolol Maleate Eye Drops 0.5% w/v in patients with Ocular Hypertension / Glaucoma

Phase 3

Completed

• Conditions: Other glaucoma,

• Registration Number: CTRI/2018/04/013091
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-06-12
• Study Start: 2018-12-04
• Last Update Posted: 2019-12-02

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• 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.

Exclusion Criteria

• 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 0.80.
• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean reduction in the IOP from baseline to end of study visit.	Day 0 and Day 90

Secondary Outcome Measures

Name	Time	Method
Mean reduction in the phasing of IOP from baseline to end of study visit.	Day 0 and Day 90

Trial Locations

Locations (19)

Aravind Eye Hospital; 🇮🇳 Coimbatore, TAMIL NADU, India

Arneja Heart and Multispeciality Hospital; 🇮🇳 Nashik, MAHARASHTRA, India

Bansal Hospital & Research Centre; 🇮🇳 Jaipur, RAJASTHAN, India

Christian Medical College and Hospital; 🇮🇳 Ludhiana, PUNJAB, India

Dept. of Ophthalmology, Institute of Medical Sciences & SUM Hospital; 🇮🇳 Khordha, ORISSA, India

Gandhi Hospital; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Government Regional Eye Hospital; 🇮🇳 Visakhapatnam, ANDHRA PRADESH, India

Govt. Medical College & Sir T. Hospital; 🇮🇳 Bhavnagar, GUJARAT, India

GSVM Medical College; 🇮🇳 Nagar, UTTAR PRADESH, India

JPM Rotary Club of Cuttack Eye Hospital; 🇮🇳 Cuttack, ORISSA, India

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Aravind Eye Hospital

🇮🇳Coimbatore, TAMIL NADU, India

Dr Ganesh Venkatraman

Principal investigator

dr.ganeshvr@cbe.aravind.org