Therapeutic Equivalence Study of Generic Brinzolamide 1% Ophthalmic Suspension Compared to Reference Listed Drug Azopt® (Brinzolamide) Ophthalmic Suspension 1% in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension.

BRIN-20-01

This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint.

2021-12-20

2022-12-29

2023-01-06

Completed

Early phase I

599

Inclusion Criteria: * Male or nonpregnant female aged 18 years or older with chronic open angle glaucoma or ocular hypertension in both eyes. * Provide signed and dated informed consent in accordance with good clinical practice and local legislation prior to any study procedure. * Be able and willing to follow study instructions and complete all required visits. * Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period. Exclusion Criteria: * Subjects with angle closure glaucoma * Females who are pregnant, breast feeding, or planning a pregnancy. * Females of childbearing potential who do not agree to utilize an adequate form of contraception. * Current, or past history of, severe hepatic or renal impairment * Current, or history within 2 months prior to baseline of, significant ocular disease * Functionally significant visual field loss * Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy * Subjects currently in another clinical trial

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 599, 'type': 'ACTUAL'}}

2024-01-18