Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01310777
First received: March 7, 2011
Last updated: January 24, 2014
Last verified: December 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean Diurnal IOP Change From Baseline at Month 3 [ Time Frame: Baseline (Day 1), Month 3 ] [ Designated as safety issue: No ]
    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).


Enrollment: 771
Study Start Date: May 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310777

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01310777     History of Changes
Other Study ID Numbers: C-10-040, 2010-024512-34
Study First Received: March 7, 2011
Results First Received: January 24, 2014
Last Updated: January 24, 2014
Health Authority: European Union: European Medicines Agency
United States: Food and Drug Administration
United States: Institutional Review Board
Singapore: Institutional Review Board
Germany: Ethics Commission
Hungary: National Institute of Pharmacy
Italy: Ethics Committee
Lithuania: Bioethics Committee
Latvia: Institutional Review Board
Portugal: Ethics Committee for Clinical Research
Spain: Comité Ético de Investigación Clínica
United Kingdom: Research Ethics Committee
Singapore: Domain Specific Review Boards
Taiwan: Institutional Review Board
Thailand: Ethical Committee
Australia: Human Research Ethics Committee
New Zealand: Health and Disability Ethics Committees

Keywords provided by Alcon Research:
Open-Angle glaucoma
Ocular Hypertension
OAG
OHT

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Cardiovascular Diseases
Eye Diseases
Vascular Diseases
Brimonidine
Brinzolamide
Ophthalmic Solutions
Pharmaceutical Solutions
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Antihypertensive Agents
Carbonic Anhydrase Inhibitors
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014