A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
- Conditions
- Primary Open Angle GlaucomaOcular Hypertension
- Interventions
- Registration Number
- NCT05022004
- Lead Sponsor
- Sun Pharmaceutical Industries Limited
- Brief Summary
This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 599
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BRIN-20-01 Brinzolamide ophthalmic suspension - Azopt® Azopt® -
- Primary Outcome Measures
Name Time Method Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups 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.
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (34)
Dr. BR Ambedkar Medical College and hospital
🇮🇳Bangalore, Karnataka, India
Rising Retina Clinic
🇮🇳Ahmedabad, Gujarat, India
Dr Agarwal's Eye Hospital
🇮🇳Tirunelveli, Tamil Nadu, India
Heritage Institute of Medical Sciences
🇮🇳Varanasi, Uttar Pradesh, India
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, Russian Federation
Healthcare Organization "Eye Center", Limited Liability Company
🇷🇺Chelyabinsk, Russian Federation
Bhagwan Mahaveer Jain Hospital
🇮🇳Bangalore, Karnataka, India
KLE's Dr. Prabhakar Kore Hospital & Medical Research Center
🇮🇳Belgaum, Karnataka, India
Sankara Nethralaya
🇮🇳Chennai, Tamil Nadu, India
Moscow Medical university n.a. Sechenov
🇷🇺Moscow, Russian Federation
Ivanovo Regional Clinical Hospital
🇷🇺Ivanovo, Russian Federation
"Eye Microsurgery" n a Academician S.N. Fedorov"
🇷🇺Kaluga, 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
Ulyanovsk ophthalmology clinical "Prozrenie"
🇷🇺Ulyanovsk, 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
GMC, Srikakulam
🇮🇳Srikakulam, Andhra Pradesh, India
Bhavna Super speciality Eye care
🇮🇳Surat, Gujarat, India
Shanti Saroj Netralay
🇮🇳Miraj, Maharashtra, India
Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences
🇮🇳Wardha, Maharashtra, India
Omkar Eye Care Center
🇮🇳Mumbai, Maharashtra, India
Institute of Human Brain of the Russian Academy of Science, 197376, Academ. Pavlov street 12 AP, StPetersburg, Russia
🇷🇺Saint Petersberg, Saint Petersburg, Russian Federation
"Angris", Limited Liability Company
🇷🇺Moscow, Russian Federation
"X7 Clinical Research", Limited Liability Company
🇷🇺Saint Petersburg, Russian Federation
"Moscow Regional Clinical Research Institute named after M.F. Vladimirsky"
🇷🇺Moscow, Russian Federation
Federal budgetary healthcare institution Privolzhsky district medical center FMBA of Russia.
🇷🇺Nizhny Novgorod, Russian Federation
Budgetary Healthcare Institution of the Omsk Region "Clinical Eye Hospital named after V.P. Vykhodtsev
🇷🇺Omsk, Russian Federation
Federal Budgetary Healthcare Institution "Volga Region Medical Centre" of the Federal Medical and Biological Agency
🇷🇺Novgorod, 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
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
Dr. RSPR Govt Regional Eye Hospital; Vishakapatnam
🇮🇳Visakhapatnam, Andhra Pradesh, India
K R Hospital, Mysore Medical College and Research Institute
🇮🇳Mysuru, Karnataka, India