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

NCT01310777 | Completed Phase 3 Results

• 2 other identifiers: C-10-0402010-024512-34
• Study Type: interventional
• Target: 771
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

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, + 2 h, and + 7 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 (3)

Brinz/Brim

EXPERIMENTAL

Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months

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

Brinz

ACTIVE COMPARATOR

Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months

Drug: Brinzolamide 1% ophthalmic suspension

Brim

ACTIVE COMPARATOR

Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months

Drug: Brimonidine tartrate 0.2% ophthalmic solution

Interventions

Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension DRUG

Brinz/Brim

Brinzolamide 1% ophthalmic suspension DRUG

Also known as: AZOPT™

Brinz

Brimonidine tartrate 0.2% ophthalmic solution DRUG

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.
• 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.

Sponsors & Collaborators

• Alcon Research: lead

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

• James Teague, Sr. Clinical Manager

  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 7, 2011
• First Posted: March 9, 2011
• Study Start: May 1, 2011
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: March 6, 2014
• Results First Posted: March 6, 2014

Record last verified: 2013-12