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

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

Official Title
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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.

Conditions
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Primary Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: Brinzolamide ophthalmic suspension
* Drug: Azopt®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BRIN-20-01<br> | Drug: Brinzolamide ophthalmic suspension<br>* dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks<br>|
| Active Comparator: Azopt®<br> | Drug: Azopt®<br>* dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in Intraocular Pressure of both eyes between the two treatment groups | The outcome measure is exactly what is in the OGD guidance: The recommended primary endpoint is the mean difference in Intraocular Pressure of both eyes between the two treatment groups at pre-specified time points. | Baseline, Week 2 & Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in IOP of both eyes between the 2 treatment groups. |  | approximately 8:00 AM. (hour 0; before the morning drop) and 10:00 AM. (hour 2) at the Day 14 (Week 2) and Day 42 (Week 6) visits |