A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Sun Pharma

Status and phase

Completed

Phase 3

Conditions

Ocular Hypertension

Primary Open Angle Glaucoma

Treatments

Drug: Azopt®

Drug: Brinzolamide ophthalmic suspension

Study type

Interventional

Funder types

Industry

Identifiers

BRIN-20-01

Details and patient eligibility

About

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

Enrollment

599 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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