A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
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.
1 other identifier
interventional
599
2 countries
40
Brief Summary
This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2021
Shorter than P25 for phase_3
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2021
CompletedFirst Posted
Study publicly available on registry
August 26, 2021
CompletedStudy Start
First participant enrolled
December 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 6, 2023
CompletedResults Posted
Study results publicly available
January 18, 2024
CompletedJanuary 18, 2024
December 1, 2023
1 year
August 19, 2021
December 22, 2023
December 22, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Baseline, Week 2 & Week 6
Secondary Outcomes (1)
Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups.
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
Study Arms (2)
BRIN-20-01
EXPERIMENTALAzopt®
ACTIVE COMPARATORInterventions
dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
GMC, Srikakulam
Srikakulam, Andhra Pradesh, 532001, India
Dr. RSPR Govt Regional Eye Hospital; Vishakapatnam
Visakhapatnam, Andhra Pradesh, 530013, India
Rising Retina Clinic
Ahmedabad, Gujarat, 380015, India
Bhavna Super speciality Eye care
Surat, Gujarat, 395002, India
Dr. BR Ambedkar Medical College and hospital
Bangalore, Karnataka, 560045, India
Bhagwan Mahaveer Jain Hospital
Bangalore, Karnataka, 560052, India
KLE's Dr. Prabhakar Kore Hospital & Medical Research Center
Belagavi, Karnataka, 590010, India
K R Hospital, Mysore Medical College and Research Institute
Mysuru, Karnataka, 570001, India
Shanti Saroj Netralay
Miraj, Maharashtra, 416410, India
Omkar Eye Care Center
Mumbai, Maharashtra, 400080, India
Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences
Wardha, Maharashtra, 442004, India
Sankara Nethralaya
Chennai, Tamil Nadu, 600006, India
Dr Agarwal's Eye Hospital
Tirunelveli, Tamil Nadu, 627003, India
Heritage Institute of Medical Sciences
Varanasi, Uttar Pradesh, 221005, India
Institute of Human Brain of the Russian Academy of Science, 197376, Academ. Pavlov street 12 AP, StPetersburg, Russia
Saint Petersberg, Sankt-Peterburg, 197376, Russia
Republican clinical ophthalmological hospital of Ministry of Health of Republic of Tatarstan named after E.V. Adamyuk
Kazan', Tatarstan Republic, 420012, Russia
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, Russia
Healthcare Organization "Eye Center", Limited Liability Company
Chelyabinsk, 454000, Russia
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, Russia
Ivanovo Regional Clinical Hospital
Ivanovo, 152040, Russia
"Eye Microsurgery" n a Academician S.N. Fedorov"
Kaluga, 248007, Russia
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, Russia
"Angris", Limited Liability Company
Moscow, 117628, Russia
Moscow Medical university n.a. Sechenov
Moscow, 119021, Russia
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, Russia
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, Russia
"Moscow Regional Clinical Research Institute named after M.F. Vladimirsky"
Moscow, 129110, Russia
Federal budgetary healthcare institution Privolzhsky district medical center FMBA of Russia.
Nizhny Novgorod, 603074, Russia
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, Russia
Budgetary Healthcare Institution of the Omsk Region "Clinical Eye Hospital named after V.P. Vykhodtsev
Omsk, 644024, Russia
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, Russia
"X7 Clinical Research", Limited Liability Company
Saint Petersburg, 194156, Russia
Feral State Budgetary Healthcare Institution "Clinical Hospital No. 122 named after L.G. Sokolov of the Federal Medical and Biological Agency"
Saint Petersburg, 194291, Russia
Samara medical university
Samara, 443099, Russia
Nongovernmental Healthcare Institution "Clinical Hospital "RZhD [Russian Railways]-
Saratov, 410004, Russia
State Budgetary Institution "Ufa Research Institute of Eye Diseases of the Academy of Sciences of the Republic of Bashkortostan
Ufa, 450008, Russia
ZAO "Optimedservice"
Ufa, 453128, Russia
Ulyanovsk ophthalmology clinical "Prozrenie"
Ulyanovsk, 432001, Russia
Federal Budgetary Healthcare Institution "Volga Region Medical Centre" of the Federal Medical and Biological Agency
Veliky Novgorod, 603001, Russia
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, Russia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Head-Clinical Development
- Organization
- Sun Pharmaceutical Industries Limited
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2021
First Posted
August 26, 2021
Study Start
December 20, 2021
Primary Completion
December 29, 2022
Study Completion
January 6, 2023
Last Updated
January 18, 2024
Results First Posted
January 18, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share