Three Month Efficacy/Safety Study With a 3-Month Safety Extension of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% or Brimonidine 0.2%

NCT ID: NCT01297920

Last Updated: 2013-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1062 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-06-30

Brief Summary

The purpose of this study was to evaluate the safety and efficacy of a new ophthalmic suspension (Brinz/Brim) in lowering intraocular pressure (IOP) relative to its individual active components in subjects with open-angle glaucoma and/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 the treatment phase, which included 4 on-therapy visits conducted at Week 2, Week 6, Month 3, and Month 6. A washout period based on previous ocular medication preceded Eligibility Visit 1. Subjects who met all inclusion/exclusion criteria at both eligibility visits were randomized to 1 of 3 study drug groups. The study was designed to evaluate the efficacy and safety of Brinzolamide/Brimonidine over a 3-month period, with an additional 3 months of study drug exposure intended to provide further safety data.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Study Design

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

Study Groups

Brinz/Brim

Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months

Group Type: EXPERIMENTAL

Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension

Intervention Type: DRUG

Brinzolamide

Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months

Group Type: ACTIVE_COMPARATOR

Brinzolamide ophthalmic suspension, 1%

Intervention Type: DRUG

Brimonidine

Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months

Group Type: ACTIVE_COMPARATOR

Brimonidine tartrate ophthalmic solution, 0.2%

Intervention Type: DRUG

Interventions

Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension

Intervention Type: DRUG

Brinzolamide ophthalmic suspension, 1%

Intervention Type: DRUG

Brimonidine tartrate ophthalmic solution, 0.2%

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Sign Informed Consent document.
• Diagnosis of open-angle glaucoma or ocular hypertension, with mean intraocular pressure within protocol-specified range at eligibility visit/s.

Exclusion Criteria

• Females of childbearing potential if pregnant, lactating, or not using highly effective birth control measures.
• Any form of glaucoma other than open-angle glaucoma.
• Severe central vision loss in either eye.
• 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 such as retinal degeneration, diabetic retinopathy, or retinal detachment.
• Best-corrected visual acuity score worse than 55 letters using the Early Treatment Diabetic Retinopathy Study chart.
• Other ocular pathology (including severe dry eye) that may, in the opinion of the Investigator, preclude the administration of study product.
• Ocular surgery within the preceding 6 months.
• Ocular laser surgery within the preceding 3 months.
• Any abnormality preventing reliable applanation tonometry.
• Any other conditions, including severe illness, which could make the subject, in the opinion of the Investigator, unsuitable for the study.

• 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

James Teague, BS, Sr. Clinical Manager

Role: STUDY_DIRECTOR

Alcon Research

Other Identifiers

C-10-039

Identifier Type: -

Identifier Source: org_study_id