Phase 2
N=637
Therapeutic Equivalence Study of Generic Brinzolamide vs Azopt
Glaucoma · Open Angle or Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT03896633 ↗Enrolled (actual)
637
Serious AEs
0.3%
Results posted
Jun 2021
Primary outcome: Primary: Intraocular Pressure (IOP) — 20.07; 19.89 mmHg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- brinzolamide 1% ophthalmic suspension (Drug); Azopt 1% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Nov 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intraocular Pressure (IOP) |
20.07; 19.89 | — |
Summary
The main purpose of this prospective study is to demonstrate the therapeutic equivalence of topical brinzolamide compared with AzoptTM
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 (NCT03896633). 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.