At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 258 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.
Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt
In Brief
A Phase 3 clinical trial evaluating brinzolamide 1% ophthalmic suspension and Azopt 1% for Glaucoma and Open Angle or Ocular Hypertension. Completed, enrolled 258 participants across 1 site.
Detailed Summary
The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide dosed three times daily compared with AzoptTM (brinzolamide ophthalmic suspension 1%) dosed three times daily in IOP reduction in patients with POAG or OH.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGlaucoma, Open Angle or Ocular Hypertension
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartJan 2012
Primary CompletionSep 2012
First PostedNov 2012
TodayJul 2026
First PostedNov 7, 2012
Enrollment StartJan 1, 2012
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 13.7 years ago
Interventions
brinzolamide 1% ophthalmic suspensiondrug
brinzolamide 1% ophthalmic suspension
Azopt 1%drug
Azopt 1%, RLD