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

Ocular Hypertension Clinical Trial

Official title:

Safety and IOP-Lowering Efficacy of Brinzolamide 10 mg/mL/Brimonidine 2 mg/mL Fixed Combination Eye Drops, Suspension Compared to Brinzolamide 10 mg/mL Eye Drops, Suspension and 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: NCT01310777
• Other study ID #: C-10-040
• Secondary ID: 2010-024512-34
• Status: Completed
• Phase: Phase 3
• First received: March 7, 2011
• Last updated: January 24, 2014
• Start date: May 2011
• Est. completion date: January 2013

Study information

• Verified date: December 2013
• 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 BoardSingapore: Institutional Review BoardGermany: Ethics CommissionHungary: National Institute of PharmacyItaly: Ethics CommitteeLithuania: Bioethics CommitteeLatvia: Institutional Review BoardPortugal: Ethics Committee for Clinical ResearchSpain: Comité Ético de Investigación ClínicaUnited Kingdom: Research Ethics CommitteeSingapore: Domain Specific Review BoardsTaiwan: Institutional Review BoardThailand: Ethical CommitteeAustralia: Human Research Ethics CommitteeNew Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial 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.

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 3 study drug groups: Brinz/Brim, Brinz, or Brim.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 771
• 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.

• 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.

• Other protocol-specified exclusion crtieria 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% ophthalmic suspension

• 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, + 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	No