Official Title: “Safety and IOP-Lowering Efficacy of Brinzolamide 10 mg/mL/Brimonidine 2 mg/mL Fixed Combination Eye Drops, Suspension Compared to Brinzolamide 10 mg/mL Eye Drops, Suspension and Brimonidine 2 mg/mL Eye Drops, Solution in Patients With Open-Angle Glaucoma or Ocular Hypertension”
The purpose of this study was to evaluate the safety and efficacy of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components in patients with open-angle glaucoma or ocular hypertension.
- Study Type: Interventional
- Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
- Study Primary Completion Date: January 2013
Detailed Clinical Trial Description
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 3 study drug groups: Brinz/Brim, Brinz, or Brim.
Interventions Used in this Clinical Trial
- Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
- Drug: Brinzolamide 1% ophthalmic suspension
- Drug: Brimonidine tartrate 0.2% ophthalmic solution
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: Brinz/Brim
- Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
- Active Comparator: Brinz
- Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
- Active Comparator: Brim
- Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
Outcome Measures for this Clinical Trial
- Mean Diurnal IOP Change From Baseline at Month 3
- Time Frame: Baseline (Day 1), Month 3
Safety Issue?: No
- Time Frame: Baseline (Day 1), Month 3
Criteria for Participation in this Clinical Trial
- 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.
- 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 ocular 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, including severe illness, which would make the subject, 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.
- Concurrent use of glucocorticoid medications administered by any route.
- Other protocol-specified exclusion crtieria may apply.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial: No
Clinical Trial Investigator Information
- Lead Sponsor
- Alcon Research
- Provider of Information About this Clinical Study
- Overall Official(s)
- James Teague, Sr. Clinical Manager, Study Director, Alcon Research