Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination

NCT ID: NCT00961649

Last Updated: 2013-07-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-02-28

Brief Summary

The purpose of this study was to compare the safety and intraocular pressure (IOP)-lowering efficacy of a new fixed combination of brinzolamide/brimonidine (Brinz/Brim) to:

• its individual components (Brinz and Brim), and
• the concomitant administration of Brinz and Brim (Brinz+Brim).

Detailed Description

This study consisted of 5 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 2 on-therapy visits conducted at Week 2 and Week 6 (or early exit). 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 4 study drug groups for 6 weeks. Study drug instillation began the morning after the second eligibility visit. The study was terminated by the sponsor out of caution due to microgel formation in the Brinz/Brim formulation. 13 remaining active subjects were discontinued. Further analysis revealed that neither the drop size nor the concentration of the active ingredients was affected.

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 and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.

Group Type: EXPERIMENTAL

Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension

Intervention Type: DRUG

Vehicle

Intervention Type: OTHER

Inactive ingredients used as placebo

Brinz

Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.

Group Type: ACTIVE_COMPARATOR

Brinzolamide ophthalmic suspension, 1%

Intervention Type: DRUG

Vehicle

Intervention Type: OTHER

Inactive ingredients used as placebo

Brim

Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.

Group Type: ACTIVE_COMPARATOR

Brimonidine tartrate ophthalmic solution, 0.2%

Intervention Type: DRUG

Vehicle

Intervention Type: OTHER

Inactive ingredients used as placebo

Brinz+Brim

Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks. A time lapse of at least 10 minutes was required between instillations of each study drug.

Group Type: ACTIVE_COMPARATOR

Brinzolamide ophthalmic suspension, 1%

Intervention Type: DRUG

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

Vehicle

Inactive ingredients used as placebo

Intervention Type: OTHER

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 patient, 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-09-038

Identifier Type: -

Identifier Source: org_study_id