Ocular Hypertension Clinical Trial
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.
| Verified date | December 2023 |
| Source | Sun Pharmaceutical Industries Limited |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint.
| Status | Completed |
| Enrollment | 599 |
| Est. completion date | January 6, 2023 |
| Est. primary completion date | December 29, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| India | Rising Retina Clinic | Ahmedabad | Gujarat |
| India | Bhagwan Mahaveer Jain Hospital | Bangalore | Karnataka |
| India | Dr. BR Ambedkar Medical College and hospital | Bangalore | Karnataka |
| India | KLE's Dr. Prabhakar Kore Hospital & Medical Research Center | Belgaum | Karnataka |
| India | Sankara Nethralaya | Chennai | Tamil Nadu |
| India | Shanti Saroj Netralay | Miraj | Maharashtra |
| India | Omkar Eye Care Center | Mumbai | Maharashtra |
| India | K R Hospital, Mysore Medical College and Research Institute | Mysuru | Karnataka |
| India | GMC, Srikakulam | Srikakulam | Andhra Pradesh |
| India | Bhavna Super speciality Eye care | Surat | Gujarat |
| India | Dr Agarwal's Eye Hospital | Tirunelveli | Tamil Nadu |
| India | Heritage Institute of Medical Sciences | Varanasi | Uttar Pradesh |
| India | Dr. RSPR Govt Regional Eye Hospital; Vishakapatnam | Visakhapatnam | Andhra Pradesh |
| India | Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences | Wardha | Maharashtra |
| Russian Federation | 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 | |
| Russian Federation | Healthcare Organization "Eye Center", Limited Liability Company | Chelyabinsk | |
| Russian Federation | 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 | |
| Russian Federation | Ivanovo Regional Clinical Hospital | Ivanovo | |
| Russian Federation | "Eye Microsurgery" n a Academician S.N. Fedorov" | Kaluga | |
| Russian Federation | Republican clinical ophthalmological hospital of Ministry of Health of Republic of Tatarstan named after E.V. Adamyuk | Kazan | Republic Of Tatarstan |
| Russian Federation | 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 | |
| Russian Federation | "Angris", Limited Liability Company | Moscow | |
| Russian Federation | "Moscow Regional Clinical Research Institute named after M.F. Vladimirsky" | Moscow | |
| Russian Federation | 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 | 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 | Moscow Medical university n.a. Sechenov | Moscow | |
| Russian Federation | Federal budgetary healthcare institution Privolzhsky district medical center FMBA of Russia. | Nizhny Novgorod | |
| Russian Federation | Federal Budgetary Healthcare Institution "Volga Region Medical Centre" of the Federal Medical and Biological Agency | Novgorod | |
| Russian Federation | 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 | |
| Russian Federation | Budgetary Healthcare Institution of the Omsk Region "Clinical Eye Hospital named after V.P. Vykhodtsev | Omsk | |
| Russian Federation | Institute of Human Brain of the Russian Academy of Science, 197376, Academ. Pavlov street 12 AP, StPetersburg, Russia | Saint Petersberg | Saint Petersburg |
| Russian Federation | "X7 Clinical Research", Limited Liability Company | Saint Petersburg | |
| Russian Federation | 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 | Feral State Budgetary Healthcare Institution "Clinical Hospital No. 122 named after L.G. Sokolov of the Federal Medical and Biological Agency" | Saint Petersburg | |
| Russian Federation | Samara medical university | Samara | |
| Russian Federation | Nongovernmental Healthcare Institution "Clinical Hospital "RZhD [Russian Railways]- | Saratov | |
| Russian Federation | State Budgetary Institution "Ufa Research Institute of Eye Diseases of the Academy of Sciences of the Republic of Bashkortostan | Ufa | |
| Russian Federation | ZAO "Optimedservice" | Ufa | |
| Russian Federation | Ulyanovsk ophthalmology clinical "Prozrenie" | Ulyanovsk | |
| Russian Federation | 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Sun Pharmaceutical Industries Limited |
India, Russian Federation,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 |
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