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

• Status: Not yet recruiting
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Pharmaceutical Industries Limited
• Treatments: Brinzolamide

Criteria

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