At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 495 enrolled
Drug / intervention
Brinzolamide 1% 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.
Multi-Center, Randomized, Double-Masked, Active Controlled, Parallel Group Study to Compare Perrigo's Brinzolamide Ophthalmic Suspension 1% to Azopt® in the Treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes
In Brief
A Phase 3 clinical trial evaluating Brinzolamide 1% ophthalmic suspension and Azopt 1% Ophthalmic Suspension for Glaucoma, Open-Angle and Ocular Hypertension. Completed, enrolled 495 participants across 1 site.
Detailed Summary
To compare the safety and efficacy of Perrigo's product to an FDA approved product in the treatment of Primary Open Angle Glaucoma or Ocular Hypertension in Both Eyes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlaucoma, Open-Angle, Ocular Hypertension
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
Enrollment StartJun 2019
First PostedJul 2019
Primary CompletionFeb 2020
Study CompletionApr 2020
TodayJul 2026
First PostedJul 18, 2019
Enrollment StartJun 24, 2019
Primary CompletionFeb 26, 2020
Study CompletionApr 30, 2020
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 7.0 years ago
Interventions
Brinzolamide 1% ophthalmic suspensiondrug
Test product
Azopt 1% Ophthalmic Suspensiondrug
Reference product