Primary Open Angle GlaucomaPhase 3NCT05022004

A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

A Phase 3 study testing Brinzolamide ophthalmic suspension and Azopt® in people with Primary Open Angle Glaucoma and Ocular Hypertension, run by Sun Pharmaceutical Industries Limited at 40 sites in 2 countries.

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

This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Primary Open Angle Glaucoma, Ocular Hypertension
What is being tested?: Brinzolamide ophthalmic suspension and Azopt®
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 599 participants
Where: 40 sitesin 2 countries
Study dates: 20 Dec 2021to 6 Jan 2023
Phase: Phase 3
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 or nonpregnant female aged 18 years or older with chronic open angle glaucoma or ocular hypertension in both eyes.
Provide signed and dated informed consent in accordance with good clinical practice and local legislation prior to any study procedure.
Be able and willing to follow study instructions and complete all required visits.
Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.

Who cannot join

Subjects with angle closure glaucoma
Females who are pregnant, breast feeding, or planning a pregnancy.
Females of childbearing potential who do not agree to utilize an adequate form of contraception.
Current, or past history of, severe hepatic or renal impairment
Current, or history within 2 months prior to baseline of, significant ocular disease
Functionally significant visual field loss
Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy
Subjects currently in another clinical trial

Trial locations and contacts

40 sites in 2 countries.

Country

City, postcode or hospital

40 sites in 2 countries

Russia26 sites

Federal State Autonomous Institution "Interdistrict Scientific and Technical Complex "Eye Microsurgery" named after Academician S.N. Fedorov" of the Ministry of Healthcare of the Russian Federation
Cheboksary, 428028
Healthcare Organization "Eye Center", Limited Liability Company
Chelyabinsk, 454000
Federal State Autonomous Institution "Interdistrict Scientific and Technical Complex "Eye Microsurgery" named after Academician S.N. Fedorov" of the Ministry of Healthcare of the Russian Federation
Irkutsk, 664017
Ivanovo Regional Clinical Hospital
Ivanovo, 152040
"Eye Microsurgery" n a Academician S.N. Fedorov"
Kaluga, 248007
Republican clinical ophthalmological hospital of Ministry of Health of Republic of Tatarstan named after E.V. Adamyuk
Kazan', Tatarstan Republic, 420012
Federal State Autonomous Institution "Interdistrict Scientific and Technical Complex "Eye Microsurgery" named after Academician S.N. Fedorov" of the Ministry of Healthcare of the Russian Federation
Khabarovsk, 680033
"Angris", Limited Liability Company
Moscow, 117628
Moscow Medical university n.a. Sechenov
Moscow, 119021
Federal State Autonomous Institution "Interdistrict Scientific and Technical Complex "Eye Microsurgery" named after Academician S.N. Fedorov" of the Ministry of Healthcare of the Russian Federation
Moscow, 127486
Federal State Budgetary Educational Institution of Higher Education "Moscow State University of Medicine and Dentistry named after A.I. Evdokimov" of the Ministry of Healthcare of the Russian Federation
Moscow, 127486
"Moscow Regional Clinical Research Institute named after M.F. Vladimirsky"
Moscow, 129110
Federal budgetary healthcare institution Privolzhsky district medical center FMBA of Russia.
Nizhny Novgorod, 603074
Federal State Autonomous Institution "Interdistrict Scientific and Technical Complex "Eye Microsurgery" named after Academician S.N. Fedorov" of the Ministry of Healthcare of the Russian Federation
Novosibirsk, 630071
Budgetary Healthcare Institution of the Omsk Region "Clinical Eye Hospital named after V.P. Vykhodtsev
Omsk, 644024
Institute of Human Brain of the Russian Academy of Science, 197376, Academ. Pavlov street 12 AP, StPetersburg, Russia
Saint Petersberg, Sankt-Peterburg, 197376
Federal State Autonomous Institution "Interdistrict Scientific and Technical Complex "Eye Microsurgery" named after Academician S.N. Fedorov" of the Ministry of Healthcare of the Russian Federation
Saint Petersburg, 192283
"X7 Clinical Research", Limited Liability Company
Saint Petersburg, 194156
Feral State Budgetary Healthcare Institution "Clinical Hospital No. 122 named after L.G. Sokolov of the Federal Medical and Biological Agency"
Saint Petersburg, 194291
Samara medical university
Samara, 443099
Nongovernmental Healthcare Institution "Clinical Hospital "RZhD [Russian Railways]-
Saratov, 410004
State Budgetary Institution "Ufa Research Institute of Eye Diseases of the Academy of Sciences of the Republic of Bashkortostan
Ufa, 450008
ZAO "Optimedservice"
Ufa, 453128
Ulyanovsk ophthalmology clinical "Prozrenie"
Ulyanovsk, 432001
Federal Budgetary Healthcare Institution "Volga Region Medical Centre" of the Federal Medical and Biological Agency
Velikiy Novgorod, 603001
Federal State Autonomous Institution "Interdistrict Scientific and Technical Complex "Eye Microsurgery" named after Academician S.N. Fedorov" of the Ministry of Healthcare of the Russian Federation
Volgograd, 400138

Other trials in Russia

India14 sites

Rising Retina Clinic
Ahmedabad, Gujarat, 380015
Dr. BR Ambedkar Medical College and hospital
Bangalore, Karnataka, 560045
Bhagwan Mahaveer Jain Hospital
Bangalore, Karnataka, 560052
KLE's Dr. Prabhakar Kore Hospital & Medical Research Center
Belagavi, Karnataka, 590010
Sankara Nethralaya
Chennai, Tamil Nadu, 600006
Shanti Saroj Netralay
Miraj, Maharashtra, 416410
Omkar Eye Care Center
Mumbai, Maharashtra, 400080
K R Hospital, Mysore Medical College and Research Institute
Mysuru, Karnataka, 570001
GMC, Srikakulam
Srikakulam, Andhra Pradesh, 532001
Bhavna Super speciality Eye care
Surat, Gujarat, 395002
Dr Agarwal's Eye Hospital
Tirunelveli, Tamil Nadu, 627003
Heritage Institute of Medical Sciences
Varanasi, Uttar Pradesh, 221005
Dr. RSPR Govt Regional Eye Hospital; Vishakapatnam
Visakhapatnam, Andhra Pradesh, 530013
Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences
Wardha, Maharashtra, 442004

Other trials in India

About this study

Official title: Therapeutic Equivalence Study of 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.

This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint.

Conditions: Primary Open Angle Glaucoma, Ocular Hypertension
Being tested: Brinzolamide ophthalmic suspension, Azopt®
Medical subject headings: Glaucoma, Open-Angle, Ocular Hypertension

What participants receive

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

Brinzolamide ophthalmic suspensionDrug
dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
Azopt®Drug
dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks

Study groups in NCT05022004
Study group	Role	What they receive
BRIN-20-01	Experimental	Not described Receives: Drug: Brinzolamide ophthalmic suspension
Azopt®	Active comparator	Not described Receives: Drug: Azopt®

What is being measured

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

Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups
The recommended primary endpoint is the mean difference in Intraocular Pressure of both eyes between the two treatment groups at pre-specified time points.
Measured: Baseline, Week 2 & Week 6

Secondary outcomes (1)

Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups.
Measured: approximately 8:00 AM. (hour 0; before the morning drop) and 10:00 AM. (hour 2) at the Day 14 (Week 2) and Day 42 (Week 6) visits

Timeline

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

20 Dec 20216 Jan 2023

First posted26 Aug 2021
Study start20 Dec 2021
Primary completion29 Dec 2022
Study completion6 Jan 2023

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 Primary Open Angle GlaucomaStudies of the same condition, open and under way.
More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 599 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05022004
Sponsor's protocol ID: BRIN-20-01
Status last verified: Dec 2023
First submitted: 19 Aug 2021
Last updated: 18 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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

Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
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Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
Glaucoma, Primary Open Angle

All Primary Open Angle Glaucoma trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Therapeutic Equivalence Study of 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: NCT05022004
Acronym / sponsor ID: BRIN-20-01
Conditions: Primary Open Angle Glaucoma, Ocular Hypertension
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 599 participants (actual)
Lead sponsor: Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
Study start: 20 Dec 2021 (actual)
Primary completion: 29 Dec 2022 (actual)
Study completion: 6 Jan 2023 (actual)
First posted: 26 Aug 2021 (actual)
Results: Posted 18 Jan 2024

Clinical summary

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

This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
BRIN-20-01	Experimental	Drug: Brinzolamide ophthalmic suspension
Azopt®	Active comparator	Drug: Azopt®

Who may qualify

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

Key inclusion criteria (4 listed)

Male or nonpregnant female aged 18 years or older with chronic open angle glaucoma or ocular hypertension in both eyes.
Provide signed and dated informed consent in accordance with good clinical practice and local legislation prior to any study procedure.
Be able and willing to follow study instructions and complete all required visits.
Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.

Key exclusion criteria (8 listed)

Subjects with angle closure glaucoma
Females who are pregnant, breast feeding, or planning a pregnancy.
Females of childbearing potential who do not agree to utilize an adequate form of contraception.
Current, or past history of, severe hepatic or renal impairment
Current, or history within 2 months prior to baseline of, significant ocular disease

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 ophthalmic suspensiondose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks	Drug	BRIN-20-01
Azopt®dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks	Drug	Azopt®

Primary outcome

Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups
Time frame: Baseline, Week 2 & Week 6
The recommended primary endpoint is the mean difference in Intraocular Pressure of both eyes between the two treatment groups at pre-specified time points.

1 secondary outcome

Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups.
Time frame: approximately 8:00 AM. (hour 0; before the morning drop) and 10:00 AM. (hour 2) at the Day 14 (Week 2) and Day 42 (Week 6) visits

Results and safety

Results posted to the registry on 18 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BRIN-20-01	297	287
Azopt®	300	289

Primary outcome: Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups

Time frame: Baseline, Week 2 & Week 6. Mean (Standard Deviation). Unit: mmHg

Measure	BRIN-20-01 n = 273	Azopt® n = 271
Baseline- Left Eye 08:00	24.92 (2.290)	25.06 (2.363)
Baseline- Right Eye 08:00	24.87 (2.378)	25.12 (2.358)
Baseline - Left Eye 10:00	24.54 (2.307)	24.83 (2.389)
Baeline - Right Eye 10:00	24.52 (2.423)	24.90 (2.365)
Week 2 - Left Eye 08:00	19.87 (3.436)	19.56 (3.642)
Week 2 - Right Eye 08:00	19.81 (3.400)	19.62 (3.423)
Week 2 - Left Eye 10:00	18.87 (3.544)	18.39 (3.760)
Week 2 - Right Eye 10:00	18.69 (3.572)	18.47 (3.468)

BRIN-20-01 vs Azopt®: Mean Difference (Final Values): 0.31 (95% CI -0.28 to 0.91)
BRIN-20-01 vs Azopt®: Mean Difference (Final Values): 0.19 (95% CI -0.39 to 0.76)
BRIN-20-01 vs Azopt®: Mean Difference (Final Values): -0.04 (95% CI -0.59 to 0.50)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 7 Weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BRIN-20-01	0 of 297 (0%)	49 of 297 (16.5%)	0 of 297
Azopt®	1 of 300 (0.3%)	38 of 300 (12.7%)	0 of 300

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Primary Open Angle Glaucoma

Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Not yet recruiting
Evaluation the Safety and Effectiveness of the GORE GDI in Adult Subjects With Primary Open-angle Glaucoma in Whom Previous Medical and Surgical Treatment Have Failed.
Glaucoma, Primary Open Angle

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.

The record lists no contact. Use the official record to reach the sponsor.

40 sites in 2 countries: 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 4 inclusion and 8 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 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 40 sites in Russia, India. 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 phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 18 Jan 2024). 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?

Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups (time frame: Baseline, Week 2 & Week 6). 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 NCT05022004.

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 18 Jan 2024.