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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

599

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

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)

December 20, 2021

Primary Completion (Actual)

December 29, 2022

Study Completion (Actual)

January 6, 2023

Study Registration Dates

First Submitted

August 19, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (Actual)

August 26, 2021

Study Record Updates

Last Update Posted (Estimated)

January 18, 2024

Last Update Submitted That Met QC Criteria

December 22, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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.

Clinical Trials on Primary Open Angle Glaucoma

Clinical Trials on Brinzolamide ophthalmic suspension

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe