At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 599 enrolled
Drug / intervention
Brinzolamide ophthalmic suspension +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating Brinzolamide ophthalmic suspension and Azopt® for Primary Open Angle Glaucoma and Ocular Hypertension. Completed, enrolled 599 participants across 40 sites in 2 countries.
Detailed Summary
This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Open Angle Glaucoma, Ocular Hypertension
CountriesIndia, Russia
Collaborators--
Timeline
Phase 3CompletedFinished
20222023202420252026
First PostedAug 2021
Enrollment StartDec 2021
Primary CompletionDec 2022
Study CompletionJan 2023
TodayJul 2026
First PostedAug 26, 2021
Enrollment StartDec 20, 2021
Primary CompletionDec 29, 2022
Study CompletionJan 6, 2023
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 4.9 years ago
Interventions
Brinzolamide ophthalmic suspensiondrug
dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
Azopt®drug
dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks