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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01310777
Recruitment Status : Completed
First Posted : March 9, 2011
Results First Posted : March 6, 2014
Last Update Posted : March 6, 2014
Information provided by (Responsible Party):
Alcon Research

Brief 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.

Condition or disease Intervention/treatment Phase
Open-Angle Glaucoma Ocular Hypertension Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension Drug: Brinzolamide 1% ophthalmic suspension Drug: Brimonidine tartrate 0.2% ophthalmic solution Phase 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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 771 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : May 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Arm Intervention/treatment
Experimental: Brinz/Brim
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
Active Comparator: Brinz
Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
Drug: Brinzolamide 1% ophthalmic suspension
Other Name: AZOPT™

Active Comparator: Brim
Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
Drug: Brimonidine tartrate 0.2% ophthalmic solution

Primary Outcome Measures :
  1. Mean Diurnal IOP Change From Baseline at Month 3 [ Time Frame: Baseline (Day 1), 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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01310777

Sponsors and Collaborators
Alcon Research
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Study Director: James Teague, Sr. Clinical Manager Alcon Research

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Responsible Party: Alcon Research Identifier: NCT01310777     History of Changes
Other Study ID Numbers: C-10-040
2010-024512-34 ( EudraCT Number )
First Posted: March 9, 2011    Key Record Dates
Results First Posted: March 6, 2014
Last Update Posted: March 6, 2014
Last Verified: December 2013
Keywords provided by Alcon Research:
Open-Angle glaucoma
Ocular Hypertension
Additional relevant MeSH terms:
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Brimonidine Tartrate
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Carbonic Anhydrase Inhibitors
Enzyme Inhibitors