NCT03896633

CompletedPhase 1/2

Therapeutic Equivalence Study of Generic Brinzolamide vs Azo...

Bausch & Lomb Incorporated Source

Bausch & Lomb Incorporated

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

883

Study Type

interventional

Actual enrollment (reported)

637

Locations

1 country

Sites

1

Timeline

Study Start

February 28, 2018

Actual (reported)

Primary Completion

November 17, 2018

Actual (reported)

Study Completion

November 17, 2018

Actual (reported)

Brief Summary

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

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 637 participants
Study completion date: November 17, 2018
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 28, 2018
Actual (reported)
Primary Completion
November 17, 2018
Actual (reported)
Study Completion
November 17, 2018
Actual (reported)
First Submitted
March 28, 2019
Actual (reported)
First Posted
April 1, 2019
Actual (reported)
Results Posted
June 9, 2021
Actual (reported)

Last Updated: May 9, 2023
Status Verified: May 2021
Results QC Date: May 14, 2021
Last Update Submitted: May 7, 2023

Conditions

Glaucoma Open Angle or Ocular Hypertension

Outcome Measures

Primary Outcomes (1)

Intraocular Pressure (IOP)
6 weeks

Other Outcomes (1)

Change in Intraocular Pressure (IOP)
6 weeks

Study Arms (2)

Azopt 1% ophthalmic suspension

ACTIVE COMPARATOR

Ophthalmic suspension

Drug: Azopt 1%

Brinzolamide 1% ophthalmic suspension

EXPERIMENTAL

ophthalmic suspension

Drug: brinzolamide 1% ophthalmic suspension

Interventions

brinzolamide 1% ophthalmic suspensionDrug

brinzolamide 1% ophthalmic suspension

Also known as: brinzolamide

Brinzolamide 1% ophthalmic suspension

Azopt 1%Drug

Azopt 1%, RLD

Also known as: brinzolamide

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male and females 18 years of age or older,
diagnosed with primary open-angle glaucoma or ocular hypertension.

You may not qualify if:

Sponsors & Collaborators

Bausch & Lomb Incorporated
Industrylead

Study Sites (1)

Various

Bridgewater, New Jersey, 08807, United States

MeSH Terms

Conditions

GlaucomaOcular Hypertension

Interventions

brinzolamide

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

Title: Daniel Donatello
Organization: Bausch & Lomb

Study Officials

Lindsey Mathew
Bausch Health Americas, Inc.
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

637 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: HEALTH SERVICES RESEARCH
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

March 28, 2019

First Posted

April 1, 2019

Study Start

February 28, 2018

Actual (reported)

NCT02051946

Novel Drug Delivery Technique Via Retroject Device

Phase 1/2Completed

NCT00661583

Use of Ranibizumab With Mitomycin C During Trabeculectomy

Phase 1/2Completed

NCT00759941

A Comparison of Azopt Versus Placebo Added to Xalatan in Patients With Elevated Intraocular Pressure (IOP) on a Prostaglandin

Phase 4Completed

NCT03551834

Ahmed Glaucoma Valve Implantation; Graft-Free Short Tunnel Small Flap Versus Scleral Patch Graft

Phase 1/2Unknown

NCT00300079

Study of the Intraocular Pressure (IOP)-Lowering Efficacy of Azopt 1.0% Compared to Timolol 0.5% in Patients With Glaucoma or Ocular Hypertension

Phase 4Completed

NCT07770685

A Study About the Safety of ASP2767 and Whether it Helps People With Glaucoma-Related Optic Nerve Damage

Phase 1/2Recruiting

Azopt 1% ophthalmic suspension

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.

Contact the study team to confirm eligibility.

Primary Completion

November 17, 2018

Actual (reported)

Study Completion

November 17, 2018

Actual (reported)

Last Updated

May 9, 2023

Results First Posted

June 9, 2021

Record last verified: 2021-05

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT03896633
Data provider: ClinicalTrials.gov
Source updated: 2023-05-09
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:33:04 UTC

Documents

Study Protocol and Statistical Analysis Plan
ProtocolSAP2018-04-12

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Other Outcomes (1)

Study Arms (2)

Azopt 1% ophthalmic suspension

Brinzolamide 1% ophthalmic suspension

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Source record

Documents

Locations