GlaucomaPhase 1/2NCT03896633

Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt

A Phase 1/2 study testing brinzolamide 1% ophthalmic suspension and Azopt 1% in people with Glaucoma and Open Angle or Ocular Hypertension, run by Bausch & Lomb Incorporated at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Glaucoma, Open Angle or Ocular Hypertension
What is being tested?: brinzolamide 1% ophthalmic suspension and Azopt 1%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 637 participants
Where: 1 siteUnited States
Study dates: 28 Feb 2018to 17 Nov 2018
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Various
Bridgewater, New Jersey, 08807

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Glaucoma, Open Angle or Ocular Hypertension
Being tested: brinzolamide 1% ophthalmic suspension, Azopt 1%
Medical subject headings: Glaucoma, Ocular Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

brinzolamide 1% ophthalmic suspensionDrug
Also called brinzolamide
brinzolamide 1% ophthalmic suspension
Azopt 1%Drug
Also called brinzolamide
Azopt 1%, RLD

Study groups in NCT03896633
Study group	Role	What they receive
Azopt 1% ophthalmic suspension	Active comparator	Ophthalmic suspension Receives: Drug: Azopt 1%
Brinzolamide 1% ophthalmic suspension	Experimental	ophthalmic suspension Receives: Drug: brinzolamide 1% ophthalmic suspension

What is being measured

The primary outcome is the main question the study is designed to answer.

Intraocular Pressure (IOP)
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Feb 201817 Nov 2018

First posted1 Apr 2019
Study start28 Feb 2018
Primary completion17 Nov 2018
Study completion17 Nov 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for GlaucomaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 637 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03896633
Sponsor's protocol ID: 883
Status last verified: May 2021
First submitted: 28 Mar 2019
Last updated: 9 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03896633
Acronym / sponsor ID: 883
Conditions: Glaucoma, Open Angle or Ocular Hypertension
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 637 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: 28 Feb 2018 (actual)
Primary completion: 17 Nov 2018 (actual)
Study completion: 17 Nov 2018 (actual)
First posted: 1 Apr 2019 (actual)
Results: Posted 9 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Azopt 1% ophthalmic suspension	Active comparator	Drug: Azopt 1%Ophthalmic suspension
Brinzolamide 1% ophthalmic suspension	Experimental	Drug: brinzolamide 1% ophthalmic suspensionophthalmic suspension

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (2 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
brinzolamide 1% ophthalmic suspensionAlso: brinzolamidebrinzolamide 1% ophthalmic suspension	Drug	Brinzolamide 1% ophthalmic suspension
Azopt 1%Also: brinzolamideAzopt 1%, RLD	Drug	Azopt 1% ophthalmic suspension

Primary outcome

Intraocular Pressure (IOP)
Time frame: 6 weeks

Results and safety

Results posted to the registry on 9 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Brinzolamide 1% Ophthalmic Suspension	321	312
Azopt 1% Ophthalmic Suspension	316	306

Primary outcome: Intraocular Pressure (IOP)

Time frame: 6 weeks. Mean (Standard Deviation). Unit: mmHg

Measure	Brinzolamide 1% Ophthalmic Suspension n = 292	Azopt 1% Ophthalmic Suspension n = 296
Value	20.07 (3.269)	19.89 (3.183)

Population analysed: The Per Protocol Population was utilized for the primary outcome, included all randomized participants who met all inclusion/exclusion criteria, instilled 75% to 125% of the planned doses for the entire duration of the study, as verified by diaries, and who did not miss the scheduled applications for more than 3 consecutive days, and completed evaluations at Day 14 and Day 42 within the designated visit window (± 4 days) with no protocol deviations that would affect the treatment evaluation.

Adverse events

Time frame: 6 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Brinzolamide 1% Ophthalmic Suspension	0 of 320 (0%)	15 of 320 (4.7%)	0 of 320
Azopt 1% Ophthalmic Suspension	2 of 318 (0.6%)	22 of 318 (6.9%)	0 of 318

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lindsey Mathew study director

Bausch Health Americas, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraocular Pressure (IOP) (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03896633.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.