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

December 22, 2023 updated by: Sun Pharmaceutical Industries Limited

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
599

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • India
    • Andhra Pradesh
      • Srikakulam, Andhra Pradesh, India, 532001
        • GMC, Srikakulam
      • Visakhapatnam, Andhra Pradesh, India, 530013
        • Dr. RSPR Govt Regional Eye Hospital; Vishakapatnam
    • Gujarat
      • Ahmedabad, Gujarat, India, 380015
        • Rising Retina Clinic
      • Surat, Gujarat, India, 395002
        • Bhavna Super speciality Eye care
    • Karnataka
      • Bangalore, Karnataka, India, 560052
        • Bhagwan Mahaveer Jain Hospital
      • Bangalore, Karnataka, India, 560045
        • Dr. BR Ambedkar Medical College and hospital
      • Belgaum, Karnataka, India, 590010
        • KLE's Dr. Prabhakar Kore Hospital & Medical Research Center
      • Mysuru, Karnataka, India, 570001
        • K R Hospital, Mysore Medical College and Research Institute
    • Maharashtra
      • Miraj, Maharashtra, India, 416410
        • Shanti Saroj Netralay
      • Mumbai, Maharashtra, India, 400080
        • Omkar Eye Care Center
      • Wardha, Maharashtra, India, 442004
        • Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600006
        • Sankara Nethralaya
      • Tirunelveli, Tamil Nadu, India, 627003
        • Dr Agarwal's Eye Hospital
    • Uttar Pradesh
      • Varanasi, Uttar Pradesh, India, 221005
        • Heritage Institute of Medical Sciences
  • Russian Federation
      • Cheboksary, Russian Federation, 428028
        • 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
      • Chelyabinsk, Russian Federation, 454000
        • Healthcare Organization "Eye Center", Limited Liability Company
      • Irkutsk, Russian Federation, 664017
        • 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
      • Ivanovo, Russian Federation, 152040
        • Ivanovo Regional Clinical Hospital
      • Kaluga, Russian Federation, 248007
        • "Eye Microsurgery" n a Academician S.N. Fedorov"
      • Khabarovsk, Russian Federation, 680033
        • 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, Russian Federation, 117628
        • "Angris", Limited Liability Company
      • Moscow, Russian Federation, 119021
        • Moscow Medical university n.a. Sechenov
      • Moscow, Russian Federation, 127486
        • 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, Russian Federation, 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, Russian Federation, 129110
        • "Moscow Regional Clinical Research Institute named after M.F. Vladimirsky"
      • Nizhny Novgorod, Russian Federation, 603074
        • Federal budgetary healthcare institution Privolzhsky district medical center FMBA of Russia.
      • Novgorod, Russian Federation, 603001
        • Federal Budgetary Healthcare Institution "Volga Region Medical Centre" of the Federal Medical and Biological Agency
      • Novosibirsk, Russian Federation, 630071
        • 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
      • Omsk, Russian Federation, 644024
        • Budgetary Healthcare Institution of the Omsk Region "Clinical Eye Hospital named after V.P. Vykhodtsev
      • Saint Petersburg, Russian Federation, 192283
        • 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, Russian Federation, 194156
        • "X7 Clinical Research", Limited Liability Company
      • Saint Petersburg, Russian Federation, 194291
        • Feral State Budgetary Healthcare Institution "Clinical Hospital No. 122 named after L.G. Sokolov of the Federal Medical and Biological Agency"
      • Samara, Russian Federation, 443099
        • Samara medical university
      • Saratov, Russian Federation, 410004
        • Nongovernmental Healthcare Institution "Clinical Hospital "RZhD [Russian Railways]-
      • Ufa, Russian Federation, 450008
        • State Budgetary Institution "Ufa Research Institute of Eye Diseases of the Academy of Sciences of the Republic of Bashkortostan
      • Ufa, Russian Federation, 453128
        • ZAO "Optimedservice"
      • Ulyanovsk, Russian Federation, 432001
        • Ulyanovsk ophthalmology clinical "Prozrenie"
      • Volgograd, Russian Federation, 400138
        • 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
    • Republic Of Tatarstan
      • Kazan, Republic Of Tatarstan, Russian Federation, 420012
        • Republican clinical ophthalmological hospital of Ministry of Health of Republic of Tatarstan named after E.V. Adamyuk
    • Saint Petersburg
      • Saint Petersberg, Saint Petersburg, Russian Federation, 197376
        • Institute of Human Brain of the Russian Academy of Science, 197376, Academ. Pavlov street 12 AP, StPetersburg, Russia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: BRIN-20-01
Drug: Brinzolamide ophthalmic suspension
dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
Active Comparator: Azopt®
Drug: Azopt®
dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, Week 2 & Week 6

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Pharmaceutical Industries Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 20, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 29, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 6, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2021

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 18, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BRIN-20-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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