Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID Plus Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension

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

Status: Completed

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

Detailed 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 2 study drug groups: Brinz/Brim or Brinz+Brim.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Starting date: May 2011
Last updated: March 7, 2014