Safety and Efficacy of Brinzolamide/Brimonidine Fixed Combination

NCT00961649 | Terminated Phase 2 Results

• 1 other identifier: C-09-038
• Study Type: interventional
• Target: 195
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Keywords

Open-Angle Glaucoma; Ocular Hypertension; Brinzolamide; Brimonidine; Intraocular Pressure

Outcome Measures

Primary Outcomes (2)

• Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, + 2 Hrs, + 7 Hrs, and + 9 Hrs) at Week 6 - Brinz/Brim, Brinz, Brim

  The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient 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). Intent-to-Treat (ITT) analysis data set was pre-specified for the comparison of Brinz/Brim to its individual components (Brinz and Brim).

  Baseline, Week 6

• Mean Change in Intraocular Pressure (IOP) From Baseline to Each of the Assessment Time Points (8 AM, +2 Hrs, +7 Hrs, and +9 Hrs) at Week 6 - Brinz/Brim, Brinz+Brim

  The study drug was instilled at 8 AM and +7 hours relative to the 8 AM dosing (approximately 15 minutes after conducting the IOP measurements). Intraocular pressure was measured by Goldmann applanation tonometry. One eye from each patient 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). Per-Protocol (PP) analysis data set was pre-specified for the comparison of Brinz/Brim to Brinz+Brim.

  Baseline, Week 6

Study Arms (4)

Brinz/Brim

EXPERIMENTAL

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.

Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension; Other: Vehicle

Brinz

ACTIVE COMPARATOR

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.

Drug: Brinzolamide ophthalmic suspension, 1%; Other: Vehicle

Brim

ACTIVE COMPARATOR

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.

Drug: Brimonidine tartrate ophthalmic solution, 0.2%; Other: Vehicle

Brinz+Brim

ACTIVE COMPARATOR

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.

Drug: Brinzolamide ophthalmic suspension, 1%; Drug: Brimonidine tartrate ophthalmic solution, 0.2%

Interventions

Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension DRUG

Brinz/Brim

Brinzolamide ophthalmic suspension, 1% DRUG

Brinz; Brinz+Brim

Brimonidine tartrate ophthalmic solution, 0.2% DRUG

Brim; Brinz+Brim

Vehicle OTHER

Inactive ingredients used as placebo

Brim; Brinz; Brinz/Brim

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alcon Research: lead

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

brinzolamide; Brimonidine Tartrate

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

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, BS, 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 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2009
• First Posted: August 19, 2009
• Study Start: October 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: July 4, 2013
• Results First Posted: July 4, 2013

Record last verified: 2013-05