Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Open-Angle Glaucoma; Ocular Hypertension
Intervention: 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)
Phase: Phase 3
Sponsored by: Alcon Research
Official(s) and/or principal investigator(s):
Steve Burmaster, PhD, Study Director, Affiliation: Alcon Research
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.
Official title: Efficacy and Safety of Brinzolamide 10 mg/mL/Brimonidine 2 mg/mL Eye Drops, Suspension Compared to Brinzolamide 10 mg/mL Eye Drops, Suspension Plus Brimonidine 2 mg/mL Eye Drops, Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Mean Diurnal IOP Change From Baseline at Month 3
This study consisted of 7 visits conducted during 2 sequential phases: the
screening/eligibility phase, which included a screening visit and 2 eligibility visits, and
a treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3,
and Month 6 (or early exit). Following washout of any IOP-lowering medication, subjects who
met all inclusion/exclusion criteria at both eligibility visits and who had IOP measurements
within the specified range during this period were randomized to 1 of 2 study drug groups:
Brinz/Brim or Brinz+Brim.
Minimum age: 18 Years.
Maximum age: N/A.
- 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.
- 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
- 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.
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Starting date: May 2011
Last updated: March 7, 2014