A Multicenteric clinical study to compare Brinzolamide 1% Ophthalmic Suspension with Dorzox (Dorzolamide) 2% Ophthalmic Solution in treatment of Elevated Intra-Ocular Pressure in Patients with Primary Open Angle Glaucoma or Ocular Hypertension

Phase 3

Completed

• Conditions: Primary Open Angle Glaucoma and Ocular Hypertension

• Registration Number: CTRI/2009/091/000578
• Lead Sponsor: Alcon Laboratories India Pvt Ltd

Brief Summary

This is a multicenter, open label, active control, parallel-group randomized study to compare the reduction of elevated intra-ocular pressure (IOP) in patients with primary open angle glaucoma or ocular hypertension. 200 patients with primary open angle glaucoma or ocular hypertension will be randomized to receive either the test or the comparator drug, instilled in the eye three times daily for a period of 12 weeks. The primary outcome measure is to demonstrate IOP reduction from baseline and demonstrate non inferiority of brinzolamide (test) 1% ophthalmic suspension compared with Dorzox (dorzolamide - comparator) 2% ophthalmic solution.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-02
• Last Update Posted: 2013-02-22

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1.Male and females 18 years of age or older, diagnosed with primary open-angle glaucoma or ocular hypertension.2.IOP measurements ≥ 24 ≤ 36 mm Hg, in atleast one eye, at 9.00 am and ≥ 21 ≤ 36 mm Hg in atleast one eye (the same eye) at 11.00 am measurement.

Exclusion Criteria

Patients with one sighted eye or amblyopia, history of chronic or recurrent inflammatory eye disease, ocular infections (3 months), ocular trauma, severe or progressive retinal or optic nerve disease, severe ocular pathology, intraocular surgery (last 12 months), laser surgery (last 3 months), current use of steroids or presence of any other form of glaucoma other than primary open angle glaucoma.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IOP reduction from baseline	12 weeks

Secondary Outcome Measures

Name	Time	Method
IOP reduction from baseline	4 and 8 weeks

Trial Locations

Locations (7)

Aravind Eye Hospital; 🇮🇳 Pondicherry, PONDICHERRY, India

Bhagwan Mahaveer Jain Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Karnataka Institute of Medical Sciences; 🇮🇳 India

Narayana Nethralaya; 🇮🇳 Bangalore, KARNATAKA, India

Siddarth Hospital; 🇮🇳 Campus,Laxmi, India

St. Johns Medical College Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Vasan Eye Care Hospital; 🇮🇳 Salem, TAMIL NADU, India

Aravind Eye Hospital

🇮🇳Pondicherry, PONDICHERRY, India

Dr. Krishnadas

Principal investigator

krishnadas@aravind.org

Dr. R. Ramakrishnan

Principal investigator

drrk@tvl.aravind.org

Dr. Sathyan

Principal investigator

dr.sathyan.p@gmail.com

Dr. Venkatesh

Principal investigator

venkatesh@pondy.aravind.org