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

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.

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

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