A clinical Trial in patients suffering from open angle glaucoma or ocular hypertension. This clinical trial is to study effect, safety and tolerability of Brinzolamide + Timolol Ophthalmic Suspension (test product) in comparison to Dorzolamide plus Timolol Maleate (reference product)eye drops.

Phase 3

Suspended

• Conditions: Open-angle glaucoma,

• Registration Number: CTRI/2012/04/002609
• Lead Sponsor: Ajanta Pharma Ltd

Brief Summary

This study is a comparative, randomized, single blind, parallel group, and multicentric, Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Tolerability of Brinzolamide 10 Mg in Combination with Timolol Maleate 5mg Ophthalmic Suspension Vs Dorzolamide 20mg + Timolol Maleate 5mg Eye Drops for the Treatment of Patients With Open Angle Glaucoma or Ocular Hypertension.The Study is proposed to start on 23 May 2012. The following primary out come will be measured at  Day 0, 1st week, 3rd week, 6th week: IOP (Intraocular pressure) Measurement. The secondary parameter will be measured at  Day 0, 1st week, 3rd week, 6th week - Eye pain, Eye redness, multicolored halos and headache. At the final visit overall response of clinical cure & overall global assessment (based on total score of signs & symptoms) will be done.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-23
• Last Update Posted: 2018-11-22

Recruitment & Eligibility

• Status: Suspended
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• 1.Male and Female patients of age 18 years and older.
• 2.Patient having clinical diagnosis of ocular hypertension.
• 3.Availability of subjects for the entire study period and willingness to adhere to protocol requirements as evidenced by written informed consent.

Exclusion Criteria

• 1.Male and Female patients of age less than 18 years.
• 2.A history of hypersensitivity to brinzolamide and other sulphonamides, timolol, or any other component of the medication.
• 4.Patients suffering from sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, or cardiogenic shock.
• 5.Patients suffering from severe allergic rhinitis and bronchial hyperreactivity.
• 6.Patients suffering from severe renal impairment (see Hepatic / Renal Impairment).
• 7.Patients who have participated in other clinical studies within 3 months.
• 8.Any condition which are likely to hinder the compliance with the protocol.
• 9.Patients should not take other topical or oral beta-blockers during the study period.
• 10.Patients with broken rear lens capsule or anterior eye lenses or in patients with known risk factors for cystoid macular edema or iritis / uveitis.
• 12.Patients who are scheduled to undergo surgery of the opposite eye during the study period.
• 13.Patients who are required to wear contact lens during the study period.
• 14.Significant visual field loss or evidence of progressive visual field loss within the last year.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
IOP (Intraocular pressure) Measurement	Day 0, first week, third week, sixth week

Secondary Outcome Measures

Name	Time	Method
Eye pain, Eye redness, multicolored halos and headache	Day 0, first week, third week, sixth week

Trial Locations

Locations (4)

Dhatri Eye Hospital; 🇮🇳 Surendranagar, GUJARAT, India

Omkar Eye Care Center; 🇮🇳 Thane, MAHARASHTRA, India

Shantanu Netralaya; 🇮🇳 Varanasi, UTTAR PRADESH, India

Shantnam Eye Care Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

Dhatri Eye Hospital

🇮🇳Surendranagar, GUJARAT, India

Dr Navin Patel

Principal investigator

9426857373

patel_navin@hotmail.com