search
Back to results

A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

Primary Purpose

Primary Open Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Brinzolamide ophthalmic suspension
Azopt®
Sponsored by
Sun Pharmaceutical Industries Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • GMC, Srikakulam
  • Dr. RSPR Govt Regional Eye Hospital; Vishakapatnam
  • Rising Retina Clinic
  • Bhavna Super speciality Eye care
  • Dr. BR Ambedkar Medical College and hospital
  • Bhagwan Mahaveer Jain Hospital
  • KLE's Dr. Prabhakar Kore Hospital & Medical Research Center
  • K R Hospital, Mysore Medical College and Research Institute
  • Shanti Saroj Netralay
  • Omkar Eye Care Center
  • Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences
  • Sankara Nethralaya
  • Dr Agarwal's Eye Hospital
  • Heritage Institute of Medical Sciences
  • Republican clinical ophthalmological hospital of Ministry of Health of Republic of Tatarstan named after E.V. Adamyuk
  • Institute of Human Brain of the Russian Academy of Science, 197376, Academ. Pavlov street 12 AP, StPetersburg, 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
  • Healthcare Organization "Eye Center", Limited Liability Company
  • 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
  • Ivanovo Regional Clinical Hospital
  • "Eye Microsurgery" n a Academician S.N. Fedorov"
  • 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
  • "Angris", Limited Liability Company
  • Moscow Medical university n.a. Sechenov
  • 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
  • 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 Regional Clinical Research Institute named after M.F. Vladimirsky"
  • Federal budgetary healthcare institution Privolzhsky district medical center FMBA of Russia.
  • Federal Budgetary Healthcare Institution "Volga Region Medical Centre" of the Federal Medical and Biological Agency
  • 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
  • Budgetary Healthcare Institution of the Omsk Region "Clinical Eye Hospital named after V.P. Vykhodtsev
  • 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
  • "X7 Clinical Research", Limited Liability Company
  • Feral State Budgetary Healthcare Institution "Clinical Hospital No. 122 named after L.G. Sokolov of the Federal Medical and Biological Agency"
  • Samara medical university
  • Nongovernmental Healthcare Institution "Clinical Hospital "RZhD [Russian Railways]-
  • State Budgetary Institution "Ufa Research Institute of Eye Diseases of the Academy of Sciences of the Republic of Bashkortostan
  • ZAO "Optimedservice"
  • Ulyanovsk ophthalmology clinical "Prozrenie"
  • 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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BRIN-20-01

Azopt®

Arm Description

Outcomes

Primary Outcome Measures

Mean difference in Intraocular Pressure of both eyes between the two treatment groups
The outcome measure is exactly what is in the OGD guidance: 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

Change from baseline in IOP of both eyes between the 2 treatment groups.

Full Information

First Posted
August 19, 2021
Last Updated
June 19, 2023
Sponsor
Sun Pharmaceutical Industries Limited
search

1. Study Identification

Unique Protocol Identification Number
NCT05022004
Brief Title
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

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
December 29, 2022 (Actual)
Study Completion Date
January 6, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharmaceutical Industries Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma, Ocular Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
599 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BRIN-20-01
Arm Type
Experimental
Arm Title
Azopt®
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Brinzolamide ophthalmic suspension
Intervention Description
dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
Intervention Type
Drug
Intervention Name(s)
Azopt®
Intervention Description
dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
Primary Outcome Measure Information:
Title
Mean difference in Intraocular Pressure of both eyes between the two treatment groups
Description
The outcome measure is exactly what is in the OGD guidance: The recommended primary endpoint is the mean difference in Intraocular Pressure of both eyes between the two treatment groups at pre-specified time points.
Time Frame
Baseline, Week 2 & Week 6
Secondary Outcome Measure Information:
Title
Change from baseline in IOP of both eyes between the 2 treatment groups.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
GMC, Srikakulam
City
Srikakulam
State/Province
Andhra Pradesh
ZIP/Postal Code
532001
Country
India
Facility Name
Dr. RSPR Govt Regional Eye Hospital; Vishakapatnam
City
Visakhapatnam
State/Province
Andhra Pradesh
ZIP/Postal Code
530013
Country
India
Facility Name
Rising Retina Clinic
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
Bhavna Super speciality Eye care
City
Surat
State/Province
Gujarat
ZIP/Postal Code
395002
Country
India
Facility Name
Dr. BR Ambedkar Medical College and hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560045
Country
India
Facility Name
Bhagwan Mahaveer Jain Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560052
Country
India
Facility Name
KLE's Dr. Prabhakar Kore Hospital & Medical Research Center
City
Belgaum
State/Province
Karnataka
ZIP/Postal Code
590010
Country
India
Facility Name
K R Hospital, Mysore Medical College and Research Institute
City
Mysuru
State/Province
Karnataka
ZIP/Postal Code
570001
Country
India
Facility Name
Shanti Saroj Netralay
City
Miraj
State/Province
Maharashtra
ZIP/Postal Code
416410
Country
India
Facility Name
Omkar Eye Care Center
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400080
Country
India
Facility Name
Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe Institute of Medical Sciences
City
Wardha
State/Province
Maharashtra
ZIP/Postal Code
442004
Country
India
Facility Name
Sankara Nethralaya
City
Chennai
State/Province
Tamil Nadu
ZIP/Postal Code
600006
Country
India
Facility Name
Dr Agarwal's Eye Hospital
City
Tirunelveli
State/Province
Tamil Nadu
ZIP/Postal Code
627003
Country
India
Facility Name
Heritage Institute of Medical Sciences
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
221005
Country
India
Facility Name
Republican clinical ophthalmological hospital of Ministry of Health of Republic of Tatarstan named after E.V. Adamyuk
City
Kazan
State/Province
Republic Of Tatarstan
ZIP/Postal Code
420012
Country
Russian Federation
Facility Name
Institute of Human Brain of the Russian Academy of Science, 197376, Academ. Pavlov street 12 AP, StPetersburg, Russia
City
Saint Petersberg
State/Province
Saint Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
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
Cheboksary
ZIP/Postal Code
428028
Country
Russian Federation
Facility Name
Healthcare Organization "Eye Center", Limited Liability Company
City
Chelyabinsk
ZIP/Postal Code
454000
Country
Russian Federation
Facility Name
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
Irkutsk
ZIP/Postal Code
664017
Country
Russian Federation
Facility Name
Ivanovo Regional Clinical Hospital
City
Ivanovo
ZIP/Postal Code
152040
Country
Russian Federation
Facility Name
"Eye Microsurgery" n a Academician S.N. Fedorov"
City
Kaluga
ZIP/Postal Code
248007
Country
Russian Federation
Facility Name
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
Khabarovsk
ZIP/Postal Code
680033
Country
Russian Federation
Facility Name
"Angris", Limited Liability Company
City
Moscow
ZIP/Postal Code
117628
Country
Russian Federation
Facility Name
Moscow Medical university n.a. Sechenov
City
Moscow
ZIP/Postal Code
119021
Country
Russian Federation
Facility Name
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
ZIP/Postal Code
127486
Country
Russian Federation
Facility Name
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
ZIP/Postal Code
127486
Country
Russian Federation
Facility Name
"Moscow Regional Clinical Research Institute named after M.F. Vladimirsky"
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
Federal budgetary healthcare institution Privolzhsky district medical center FMBA of Russia.
City
Nizhny Novgorod
ZIP/Postal Code
603074
Country
Russian Federation
Facility Name
Federal Budgetary Healthcare Institution "Volga Region Medical Centre" of the Federal Medical and Biological Agency
City
Novgorod
ZIP/Postal Code
603001
Country
Russian Federation
Facility Name
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
Novosibirsk
ZIP/Postal Code
630071
Country
Russian Federation
Facility Name
Budgetary Healthcare Institution of the Omsk Region "Clinical Eye Hospital named after V.P. Vykhodtsev
City
Omsk
ZIP/Postal Code
644024
Country
Russian Federation
Facility Name
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
ZIP/Postal Code
192283
Country
Russian Federation
Facility Name
"X7 Clinical Research", Limited Liability Company
City
Saint Petersburg
ZIP/Postal Code
194156
Country
Russian Federation
Facility Name
Feral State Budgetary Healthcare Institution "Clinical Hospital No. 122 named after L.G. Sokolov of the Federal Medical and Biological Agency"
City
Saint Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
Samara medical university
City
Samara
ZIP/Postal Code
443099
Country
Russian Federation
Facility Name
Nongovernmental Healthcare Institution "Clinical Hospital "RZhD [Russian Railways]-
City
Saratov
ZIP/Postal Code
410004
Country
Russian Federation
Facility Name
State Budgetary Institution "Ufa Research Institute of Eye Diseases of the Academy of Sciences of the Republic of Bashkortostan
City
Ufa
ZIP/Postal Code
450008
Country
Russian Federation
Facility Name
ZAO "Optimedservice"
City
Ufa
ZIP/Postal Code
453128
Country
Russian Federation
Facility Name
Ulyanovsk ophthalmology clinical "Prozrenie"
City
Ulyanovsk
ZIP/Postal Code
432001
Country
Russian Federation
Facility Name
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
Volgograd
ZIP/Postal Code
400138
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

We'll reach out to this number within 24 hrs