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

Alcon

Status and phase: Completed; Phase 3

Conditions: Open-Angle Glaucoma; Ocular Hypertension

Treatments: Drug: Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension; Drug: Vehicle; Drug: Brimonidine tartrate 0.2% ophthalmic solution; Drug: Brinzolamide 1% ophthalmic suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT01309204

C-10-041

2010-024513-31 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,184 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,184 participants in 2 patient groups

Brinz/Brim

Experimental group

Description:

Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.

Treatment:

Drug: Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension

Drug: Vehicle

Brinz+Brim

Active Comparator group

Description:

Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.

Treatment:

Drug: Brimonidine tartrate 0.2% ophthalmic solution

Drug: Brinzolamide 1% ophthalmic suspension