A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
NCT ID: NCT05022004
Last Updated: 2024-01-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
599 participants
INTERVENTIONAL
2021-12-20
2023-01-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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BRIN-20-01
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
Azopt®
Azopt®
dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
Interventions
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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
Azopt®
dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sun Pharmaceutical Industries Limited
INDUSTRY
Responsible Party
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Locations
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GMC, Srikakulam
Srikakulam, Andhra Pradesh, India
Dr. RSPR Govt Regional Eye Hospital; Vishakapatnam
Visakhapatnam, Andhra Pradesh, India
Rising Retina Clinic
Ahmedabad, Gujarat, India
Bhavna Super speciality Eye care
Surat, Gujarat, India
Dr. BR Ambedkar Medical College and hospital
Bangalore, Karnataka, India
Bhagwan Mahaveer Jain Hospital
Bangalore, Karnataka, India
KLE's Dr. Prabhakar Kore Hospital & Medical Research Center
Belagavi, Karnataka, India
K R Hospital, Mysore Medical College and Research Institute
Mysuru, Karnataka, India
Shanti Saroj Netralay
Miraj, Maharashtra, India
Omkar Eye Care Center
Mumbai, Maharashtra, India
Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences
Wardha, Maharashtra, India
Sankara Nethralaya
Chennai, Tamil Nadu, India
Dr Agarwal's Eye Hospital
Tirunelveli, Tamil Nadu, India
Heritage Institute of Medical Sciences
Varanasi, Uttar Pradesh, India
Institute of Human Brain of the Russian Academy of Science, 197376, Academ. Pavlov street 12 AP, StPetersburg, Russia
Saint Petersberg, Sankt-Peterburg, Russia
Republican clinical ophthalmological hospital of Ministry of Health of Republic of Tatarstan named after E.V. Adamyuk
Kazan', Tatarstan Republic, 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, , Russia
Healthcare Organization "Eye Center", Limited Liability Company
Chelyabinsk, , 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, , Russia
Ivanovo Regional Clinical Hospital
Ivanovo, , Russia
"Eye Microsurgery" n a Academician S.N. Fedorov"
Kaluga, , 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, , Russia
"Angris", Limited Liability Company
Moscow, , Russia
Moscow Medical university n.a. Sechenov
Moscow, , 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, , 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, , Russia
"Moscow Regional Clinical Research Institute named after M.F. Vladimirsky"
Moscow, , Russia
Federal budgetary healthcare institution Privolzhsky district medical center FMBA of Russia.
Nizhny Novgorod, , 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, , Russia
Budgetary Healthcare Institution of the Omsk Region "Clinical Eye Hospital named after V.P. Vykhodtsev
Omsk, , 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, , Russia
"X7 Clinical Research", Limited Liability Company
Saint Petersburg, , Russia
Feral State Budgetary Healthcare Institution "Clinical Hospital No. 122 named after L.G. Sokolov of the Federal Medical and Biological Agency"
Saint Petersburg, , Russia
Samara medical university
Samara, , Russia
Nongovernmental Healthcare Institution "Clinical Hospital "RZhD [Russian Railways]-
Saratov, , Russia
State Budgetary Institution "Ufa Research Institute of Eye Diseases of the Academy of Sciences of the Republic of Bashkortostan
Ufa, , Russia
ZAO "Optimedservice"
Ufa, , Russia
Ulyanovsk ophthalmology clinical "Prozrenie"
Ulyanovsk, , Russia
Federal Budgetary Healthcare Institution "Volga Region Medical Centre" of the Federal Medical and Biological Agency
Veliky Novgorod, , 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, , Russia
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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BRIN-20-01
Identifier Type: -
Identifier Source: org_study_id
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