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Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

Primary Purpose

Glaucoma, Open Angle or Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
brinzolamide 1% ophthalmic suspension
Azopt 1%
Sponsored by
Bausch & Lomb Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

  • US01

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) at Week 12

Secondary Outcome Measures

Change in Intraocular Pressure (IOP) From Baseline to Week 12

Full Information

First Posted
November 5, 2012
Last Updated
May 7, 2023
Sponsor
Bausch & Lomb Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT01722604
Brief Title
Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bausch & Lomb Incorporated

4. Oversight

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 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 3
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
258 (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
Intervention Description
brinzolamide 1% ophthalmic suspension
Intervention Type
Drug
Intervention Name(s)
Azopt 1%
Intervention Description
Azopt 1%, RLD
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP) at Week 12
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Change in Intraocular Pressure (IOP) From Baseline to Week 12
Time Frame
Baseline, Week 12

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.
Facility Information:
Facility Name
US01
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

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