Conditions: Glaucoma
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 973
Healthy volunteers: no

Brief summary:
This is a randomized, double blind, two-arm, parallel group, active controlled bioequivalence study, at multiple clinical trial sites designed to demonstrate bioequivalence of Brinzolamide 1% ophthalmic suspension (manufactured by Indoco Remedies Ltd. for Watson Pharma Pvt Ltd.), to Brinzolamide (Azopt®) 1% ophthalmic suspension of Alcon Laboratories, Inc. in the treatment of chronic open angle glaucoma or ocular hypertension in both eyes.

Detailed description:
Study will be conducted in adult subjects, above 18 years inclusive, males and non pregnant females, diagnosed with chronic open angle glaucoma or ocular hypertension in both eyes. Qualifying Intra Ocular Pressure (IOPs) following wash-out, at baseline (Day 0/hour 0 i.e., 8:00 am) should be ≥ 22 milli meter mercury (mm Hg) and ≤ 34 mm Hg in each eye and any asymmetry of IOP between the eyes no greater than 5 mm Hg.

Each study subject will use one drop of test or reference Ophthalmic Suspension in both the eyes three times daily at approximately 8:00am, 04:00 pm and 10:00 pm for 42 days (6 weeks). The dose and mode of treatment chosen in this study is the dosage approved by United States Food and Drug administration (US FDA) for use in treatment of patients of Chronic Open Angle Glaucoma.

The study subjects will undergo clinical evaluations throughout the study in order to assess efficacy and safety. Study subject primary endpoint evaluation will be assessed after 2 weeks (14 days) and 6 weeks (42 days) of treatment for each study subject deemed eligible for evaluation, (i.e., at Visit III - Day 14 ± 2 days and Visit IV - Day 42 ± 3 days).

The primary bioequivalence comparison is between the test and reference products for the mean difference in intraocular pressure (IOP) of both eyes at four time points, i.e., at approximately 8:00 am and 10:00 am at the Day 14 (± 2 days) and Day 42 (± 3 days) visits.

Arms:
arm 1: Brinzolamide Pharmaceutical dosage form: Ophthalmic suspension Strength: 1% Manufactured by: Indoco Remedies, Ltd for Watson Pharma Pvt. Ltd arm 2: Azopt® (Contains Brinzolamide) Pharmaceutical dosage form: Ophthalmic suspension Strength: 1% Manufactured by: Alcon Laboratories, Inc

Interventions: intervention 1: Test-Brinzolamide 1% Ophthalmic suspension intervention 2: Reference-Brinzolamide 1% Ophthalmic suspension
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: