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Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

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ClinicalTrials.gov Identifier: NCT03896633
Recruitment Status : Completed
First Posted : April 1, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

Brief Summary:
The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide compared with AzoptTM

Condition or disease Intervention/treatment Phase
Glaucoma Open Angle or Ocular Hypertension Drug: brinzolamide 1% ophthalmic suspension Drug: Azopt 1% Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 637 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
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
Actual Study Start Date : February 28, 2018
Actual Primary Completion Date : November 17, 2018
Actual Study Completion Date : November 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: Azopt 1% ophthalmic suspension
Ophthalmic suspension
Drug: Azopt 1%
Azopt 1%, RLD
Other Name: brinzolamide

Experimental: Brinzolamide 1% ophthalmic suspension
ophthalmic suspension
Drug: brinzolamide 1% ophthalmic suspension
brinzolamide 1% ophthalmic suspension
Other Name: brinzolamide




Primary Outcome Measures :
  1. Intraocular pressure (IOP) [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Change in intraocular pressure (IOP) [ Time Frame: 6 weeks ]
    Change in intraocular pressure (IOP) from baseline (Eligibility Visit 2) and after treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03896633


Locations
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United States, New Jersey
Various
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Bausch Health Americas, Inc.
Investigators
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Study Director: Lindsey Mathew Bausch Health Americas, Inc.

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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT03896633     History of Changes
Other Study ID Numbers: 883
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Brinzolamide
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action