Clinical trial NCT05022004: A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Open Angle Glaucoma
Ocular Hypertension
Lead sponsor: Sun Pharmaceutical Industries Limited
Sponsor class: INDUSTRY
First posted: 2021-08-26
Enrollment: 599
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint.


Eligibility criteria: 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

Primary outcomes:
measure: Mean Difference in Intraocular Pressure of Both Eyes Between the Two Treatment Groups
timeFrame: Baseline, Week 2 & Week 6
Secondary outcomes:
measure: Change From Baseline in IOP of Both Eyes Between the 2 Treatment Groups.
timeFrame: 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
Other outcomes:
Locations:
city: Srikakulam
country: India
facility: GMC, Srikakulam
state: Andhra Pradesh
city: Visakhapatnam
country: India
facility: Dr. RSPR Govt Regional Eye Hospital; Vishakapatnam
state: Andhra Pradesh
city: Ahmedabad
country: India
facility: Rising Retina Clinic
state: Gujarat
city: Surat
country: India
facility: Bhavna Super speciality Eye care
state: Gujarat
city: Bangalore
country: India
facility: Dr. BR Ambedkar Medical College and hospital
state: Karnataka
city: Bangalore
country: India
facility: Bhagwan Mahaveer Jain Hospital
state: Karnataka
city: Belgaum
country: India
facility: KLE's Dr. Prabhakar Kore Hospital & Medical Research Center
state: Karnataka
city: Mysuru
country: India
facility: K R Hospital, Mysore Medical College and Research Institute
state: Karnataka
city: Miraj
country: India
facility: Shanti Saroj Netralay
state: Maharashtra
city: Mumbai
country: India
facility: Omkar Eye Care Center
state: Maharashtra
city: Wardha
country: India
facility: Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences
state: Maharashtra
city: Chennai
country: India
facility: Sankara Nethralaya
state: Tamil Nadu
city: Tirunelveli
country: India
facility: Dr Agarwal's Eye Hospital
state: Tamil Nadu
city: Varanasi
country: India
facility: Heritage Institute of Medical Sciences
state: Uttar Pradesh
city: Kazan
country: Russian Federation
facility: Republican clinical ophthalmological hospital of Ministry of Health of Republic of Tatarstan named after E.V. Adamyuk
state: Republic Of Tatarstan
city: Saint Petersberg
country: Russian Federation
facility: Institute of Human Brain of the Russian Academy of Science, 197376, Academ. Pavlov street 12 AP, StPetersburg, Russia
state: Saint Petersburg
city: Cheboksary
country: Russian Federation
facility: 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
city: Chelyabinsk
country: Russian Federation
facility: Healthcare Organization "Eye Center", Limited Liability Company
city: Irkutsk
country: Russian Federation
facility: 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
city: Ivanovo
country: Russian Federation
facility: Ivanovo Regional Clinical Hospital
city: Kaluga
country: Russian Federation
facility: "Eye Microsurgery" n a Academician S.N. Fedorov"
city: Khabarovsk
country: Russian Federation
facility: 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
city: Moscow
country: Russian Federation
facility: "Angris", Limited Liability Company
city: Moscow
country: Russian Federation
facility: Moscow Medical university n.a. Sechenov
city: Moscow
country: Russian Federation
facility: 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
city: Moscow
country: Russian Federation
facility: 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
city: Moscow
country: Russian Federation
facility: "Moscow Regional Clinical Research Institute named after M.F. Vladimirsky"
city: Nizhny Novgorod
country: Russian Federation
facility: Federal budgetary healthcare institution Privolzhsky district medical center FMBA of Russia.
city: Novgorod
country: Russian Federation
facility: Federal Budgetary Healthcare Institution "Volga Region Medical Centre" of the Federal Medical and Biological Agency
city: Novosibirsk
country: Russian Federation
facility: 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
city: Omsk
country: Russian Federation
facility: Budgetary Healthcare Institution of the Omsk Region "Clinical Eye Hospital named after V.P. Vykhodtsev
city: Saint Petersburg
country: Russian Federation
facility: 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
city: Saint Petersburg
country: Russian Federation
facility: "X7 Clinical Research", Limited Liability Company
city: Saint Petersburg
country: Russian Federation
facility: Feral State Budgetary Healthcare Institution "Clinical Hospital No. 122 named after L.G. Sokolov of the Federal Medical and Biological Agency"
city: Samara
country: Russian Federation
facility: Samara medical university
city: Saratov
country: Russian Federation
facility: Nongovernmental Healthcare Institution "Clinical Hospital "RZhD [Russian Railways]-
city: Ufa
country: Russian Federation
facility: State Budgetary Institution "Ufa Research Institute of Eye Diseases of the Academy of Sciences of the Republic of Bashkortostan
city: Ufa
country: Russian Federation
facility: ZAO "Optimedservice"
city: Ulyanovsk
country: Russian Federation
facility: Ulyanovsk ophthalmology clinical "Prozrenie"
city: Volgograd
country: Russian Federation
facility: 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
Study officials:
References: