Phase 3
N=258
Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt
Glaucoma · Open Angle or Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01722604 ↗Enrolled (actual)
258
Serious AEs
1.9%
Results posted
Jun 2021
Primary outcome: Primary: Intraocular Pressure (IOP) at Week 12 — 20.6; 20.8 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- brinzolamide 1% ophthalmic suspension (Drug); Azopt 1% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Sep 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure (IOP) at Week 12 |
20.6; 20.8 | — |
| SECONDARY Change in Intraocular Pressure (IOP) From Baseline to Week 12 |
-5.3; -5.4 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male and females 18 years of age or older,
- diagnosed with primary open-angle glaucoma or ocular hypertension.
Exclusion Criteria
- Patients with any form of glaucoma (such as secondary, congenital, juvenile or normal tension glaucoma, angle closure glaucoma) in either eye other than primary open-angle glaucoma,
- ocular hypertension.
Data sourced from ClinicalTrials.gov (NCT01722604). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.