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

NCT ID: NCT01309204

Last Updated: 2014-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1184 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-01-31

Brief 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.

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.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Brinz/Brim

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

Vehicle

Intervention Type: DRUG

Inactive ingredients used as a placebo for masking purposes

Brinz+Brim

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.

Group Type: ACTIVE_COMPARATOR

Brinzolamide 1% ophthalmic suspension

Intervention Type: DRUG

Brimonidine tartrate 0.2% ophthalmic solution

Intervention Type: DRUG

Interventions

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

Intervention Type: DRUG

Vehicle

Inactive ingredients used as a placebo for masking purposes

Intervention Type: DRUG

Brinzolamide 1% ophthalmic suspension

Intervention Type: DRUG

Brimonidine tartrate 0.2% ophthalmic solution

Intervention Type: DRUG

Other Intervention Names

AZOPT™

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steve Burmaster, PhD

Role: STUDY_DIRECTOR

Alcon Research

References

Gandolfi SA, Lim J, Sanseau AC, Parra Restrepo JC, Hamacher T. Randomized trial of brinzolamide/brimonidine versus brinzolamide plus brimonidine for open-angle glaucoma or ocular hypertension. Adv Ther. 2014 Dec;31(12):1213-27. doi: 10.1007/s12325-014-0168-y. Epub 2014 Nov 28.

Reference Type: DERIVED

PMID: 25430900 (View on PubMed)

Other Identifiers

2010-024513-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C-10-041

Identifier Type: -

Identifier Source: org_study_id