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

Ocular Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309204
• Other study ID #: C-10-041
• Secondary ID: 2010-024513-31
• Status: Completed
• Phase: Phase 3
• First received: March 3, 2011
• Last updated: March 7, 2014
• Start date: May 2011
• Est. completion date: January 2013

Study information

• Verified date: March 2014
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: European Union: European Medicines AgencyUnited States: Food and Drug AdministrationUnited States: Institutional Review BoardArgentina: Human Research Bioethics CommitteeAustralia: Human Research Ethics CommitteeAustria: EthikkommissionBelgium: Ethics CommitteeBrazil: National Committee of Ethics in ResearchCanada: Ethics Review CommitteeFrance: Committee for the Protection of PersonnesGermany: Ethics CommissionHungary: Research Ethics Medical CommitteeIndia: Institutional Review BoardItaly: Ethics CommitteeLithuania: Bioethics CommitteeNetherlands: Medical Ethics Review Committee (METC)New Zealand: Ethics CommitteePoland: Ethics CommitteePortugal: Ethics Committee for Clinical ResearchSpain: Comité Ético de Investigación ClínicaSweden: Regional Ethical Review BoardUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1184
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open-Angle Glaucoma

Intervention

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

• Vehicle
Inactive ingredients used as a placebo for masking purposes
• Brinzolamide 1% ophthalmic suspension

• Brimonidine tartrate 0.2% ophthalmic solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No