Phase 3
N=888
Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension
Open-Angle Glaucoma · Ocular Hypertension
Bottom Line
View on ClinicalTrials.gov: NCT01309204 ↗Enrolled (actual)
888
Serious AEs
2.1%
Results posted
Apr 2014
Primary outcome: Primary: Mean Diurnal IOP Change From Baseline at Month 3 — -8.5; -8.3 millimeters of mercury (mmHg)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension (Drug); Vehicle (Drug); Brinzolamide 1% ophthalmic suspension (Drug); Brimonidine tartrate 0.2% ophthalmic solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Jan 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Diurnal IOP Change From Baseline at Month 3 |
-8.5; -8.3 | — |
Summary
The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine fixed combination in lowering intraocular pressure (IOP) relative to each of its individual active constituents instilled concomitantly (Brinzolamide+Brimonidine) in patients with open-angle glaucoma or ocular hypertension.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with open-angle glaucoma or ocular hypertension and, in the opinion of the Investigator, are insufficiently controlled on monotherapy or are currently on multiple IOP-lowering medications.
- Meet qualifying IOP entry criteria.
- Able to understand and sign an informed consent form.
- Other protocol-specified inclusion criteria may apply.
Exclusion Criteria
- Women of childbearing potential if pregnant, test positive for pregnancy at Screening visit, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study.
- Severe central visual field loss.
- Can not safely undergo the initial washout period and discontinue use of all IOP-lowering ocular medication(s) for the minimum specified period prior to Eligibility Visit 1.
- Best corrected visual acuity (BCVA) score worse than 55 ETDRS letters (20/80 Snellen equivalent).
- Chronic, recurrent or severe inflammatory eye disease.
- Ocular trauma within the preceding 6 months.
- Ocular infection or inflammation within the preceding 3 months.
- Clinically significant or progressive retinal disease.
- Other ocular pathology.
- Intraocular surgery within the 6 months prior to entry.
- Ocular laser surgery within the 3 months prior to entry.
- Any abnormality preventing reliable applanation tonometry.
- Any other conditions which would make the patient, in the opinion of the Investigator, unsuitable for the study.
- Recent use of high-dose (>1 gram daily) salicylate therapy.
- Recent, current, or anticipated treatment with any medication that augments adrenergic responses, or precludes use of an alpha-adrenergic agonist.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01309204). 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.