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

Information source: Alcon Research
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Open-Angle Glaucoma; Ocular Hypertension

Intervention: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension (Drug); Brinzolamide ophthalmic suspension, 1% (Drug); Brimonidine tartrate ophthalmic solution, 0.2% (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Alcon Research

Official(s) and/or principal investigator(s):
James Teague, BS, Sr. Clinical Manager, Study Director, Affiliation: Alcon Research


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.

Clinical Details

Official title: A Three-Month, Randomized, Double-Masked, Parallel-Group Study With a Planned Three-Month Safety Extension of the Efficacy and Safety of a Fixed Combination of Brinzolamide 1%/Brimonidine 0.2% Compared to Brinzolamide 1% and Brimonidine 0.2% All Dosed Three Times Daily in Patients With Open-Angle Glaucoma and/or Ocular Hypertension

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Mean Intraocular Pressure (IOP) at Each Assessment Timepoint (8 AM, +2 h, +7 h, and +9 h) at Month 3

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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.

- Other protocol-specified inclusion criteria may apply.

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.

- Other protocol-specified exclusion criteria may apply.

Locations and Contacts

Additional Information

Starting date: March 2011
Last updated: May 17, 2013

Page last updated: August 20, 2015

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