Overview

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