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

NCT01309204 | Completed Phase 3 Results

• 2 other identifiers: C-10-0412010-024513-31
• Study Type: interventional
• Target: 1,184
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Keywords

open-angle glaucoma; ocular hypertension; OAG; OHT

Outcome Measures

Primary Outcomes (1)

• Mean Diurnal IOP Change From Baseline at Month 3

  Mean Diurnal IOP Change from Baseline at Month 3 (ie, the subject IOP change from baseline averaged over the 9 AM and + 2 h time points at Month 3) was measured by Goldmann applanation tonometry. The study drug was instilled approximately 15 minutes after conducting the 9AM IOP measurement. One eye from each subject was chosen as the study eye, and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).

  Baseline (Day 1), Month 3

Study Arms (2)

Brinz/Brim

EXPERIMENTAL

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.

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

Brinz+Brim

ACTIVE COMPARATOR

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.

Drug: Brinzolamide 1% ophthalmic suspension; Drug: Brimonidine tartrate 0.2% ophthalmic solution

Interventions

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

Brinz/Brim

Vehicle DRUG

Inactive ingredients used as a placebo for masking purposes

Brinz/Brim

Brinzolamide 1% ophthalmic suspension DRUG

Also known as: AZOPT™

Brinz+Brim

Brimonidine tartrate 0.2% ophthalmic solution DRUG

Brinz+Brim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

Related Publications (1)

• 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.

  PMID: 25430900 DERIVED

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

brinzolamide; Brimonidine Tartrate; Ophthalmic Solutions

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Results Point of Contact

• Title: Matt Walker, PhD, Clinical Project Lead
• Organization: Alcon Research, Ltd.

alcon.medinfo@alcon.com

1-888-451-3937

Study Officials

• Steve Burmaster, PhD

  Alcon Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2011
• First Posted: March 7, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 7, 2014
• Results First Posted: April 7, 2014

Record last verified: 2014-03