Back to resultsTherapeutic Equivalence Study of Generic Brinzolamide vs Azopt
Primary Purpose
Glaucoma, Open Angle or Ocular Hypertension
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
brinzolamide 1% ophthalmic suspension
Azopt 1%
Sponsored by
About this trial
This is an interventional health services research trial for Glaucoma
Eligibility Criteria
Inclusion Criteria:
- Male and females 18 years of age or older,
- diagnosed with primary open-angle glaucoma or ocular hypertension.
Exclusion Criteria:
- Patients with any form of glaucoma (such as secondary, congenital, juvenile or normal tension glaucoma, angle closure glaucoma) in either eye other than primary open-angle glaucoma,
- ocular hypertension.
Sites / Locations
- Various
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Azopt 1% ophthalmic suspension
Brinzolamide 1% ophthalmic suspension
Arm Description
Ophthalmic suspension
ophthalmic suspension
Outcomes
Primary Outcome Measures
Intraocular Pressure (IOP)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03896633
Brief Title
Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt
Official Title
A BIOEQUIVALENCE STUDY OF THE 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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 28, 2018 (Actual)
Primary Completion Date
November 17, 2018 (Actual)
Study Completion Date
November 17, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide compared with AzoptTM
Detailed Description
The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open Angle or Ocular Hypertension
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
637 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Azopt 1% ophthalmic suspension
Arm Type
Active Comparator
Arm Description
Ophthalmic suspension
Arm Title
Brinzolamide 1% ophthalmic suspension
Arm Type
Experimental
Arm Description
ophthalmic suspension
Intervention Type
Drug
Intervention Name(s)
brinzolamide 1% ophthalmic suspension
Other Intervention Name(s)
brinzolamide
Intervention Description
brinzolamide 1% ophthalmic suspension
Intervention Type
Drug
Intervention Name(s)
Azopt 1%
Other Intervention Name(s)
brinzolamide
Intervention Description
Azopt 1%, RLD
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Time Frame
6 weeks
Other Pre-specified Outcome Measures:
Title
Change in Intraocular Pressure (IOP)
Description
Change in intraocular pressure (IOP) from baseline (Eligibility Visit 2) and after treatment.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and females 18 years of age or older,
diagnosed with primary open-angle glaucoma or ocular hypertension.
Exclusion Criteria:
Patients with any form of glaucoma (such as secondary, congenital, juvenile or normal tension glaucoma, angle closure glaucoma) in either eye other than primary open-angle glaucoma,
ocular hypertension.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lindsey Mathew
Organizational Affiliation
Bausch Health Americas, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Various
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt
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