A clinical trial to study and compare the effects of two once a daily eye drops in patients with open angle Glaucoma and ocular hypertension.

Phase 3

Completed

• Conditions: Health Condition 1: H401- Open-angle glaucomaHealth Condition 2: null- Patients with Glaucoma and ocular hypertension

• Registration Number: CTRI/2011/12/002313
• Lead Sponsor: Sun Pharma Advanced Research Company Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Men and women aged 18 years and above.

Unmedicated IOP equal to or greater than 22 mmHg in one or both eyes

Visual acuity 6/60 or better

Willingness to participate and giving written informed consent

Willing to commit to study medication-dosing, study visits and follow-up visits to complete evaluation

Exclusion Criteria

Pigmentary glaucoma

Intraocular conventional surgery or laser surgery within the past six months

Refractive surgery in study eye

Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy

Ocular trauma within the past 3 months

Progressive retinal or optic nerve disease apart from glaucoma

Concurrent infectious/non infectious conjunctivitis, keratitis, or uveitis in either eye

Contact lens wear within 15 minutes of instillation of study medication

Women of childbearing potential who have positive serum pregnancy test or are lactating or not using adequate contraception

Clinically significant systemic disease, which might interfere with the study

History of non-compliance to medical regimens or unwilling to comply with the study protocol

Participation in another clinical study within the last thirty (30) days

Changes in systemic medication within 30 days prior to screening that could have a substantial impact on IOP, or anticipated changes during the study

Refusal or inability to give written informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified