Phase 3
Completed N=258
Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt
Glaucoma · Open Angle or Ocular Hypertension
Source: ClinicalTrials.gov NCT01722604 ↗
Enrolled (actual)
258
Serious AEs
1.9%
Results posted
Jun 2021
Primary outcomePrimary: Intraocular Pressure (IOP) at Week 12 — 20.6; 20.8 mmHg
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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. Informational only — not medical advice.