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Efficacy and Safety Study of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% and Brimonidine 0.2%

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01297517
First received: February 15, 2011
Last updated: May 14, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study was to evaluate the efficacy and safety of a fixed combination of Brinzolamide/Brimonidine in lowering intraocular pressure (IOP) relative to each of its individual active components in patients with open-angle glaucoma and/or ocular hypertension.


Condition Intervention Phase
Open-Angle Glaucoma
Ocular Hypertension
 Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
Drug: Brinzolamide ophthalmic suspension, 1%
Drug: Brimonidine tartrate ophthalmic solution, 0.2%
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Three Month Efficacy and Safety Study 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h) [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    At the Month 3 (Exit) visit, the 8 am IOP measurement was taken before instillation of study drug. The study drug was instilled approximately 15 minutes after the 8 am measurement. An additional dose was given at 3 pm. 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).


Enrollment: 1001
Study Start Date: February 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brinzolamide/Brimonidine
Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day for 3 months
 Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
Active Comparator: Brinzolamide
Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day for 3 months
 Drug: Brinzolamide ophthalmic suspension, 1%
Other Name: AZOPT®
Active Comparator: Brimonidine
Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day for 3 months
 Drug: Brimonidine tartrate ophthalmic solution, 0.2%

Detailed Description:

This study consisted of 6 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 3 on-therapy visits conducted at Week 2, Week 6, and Month 3. A washout period based on previous ocular medication preceded Eligibility Visit 1. Patients who met all inclusion/exclusion criteria at both eligibility visits were randomized (1:1:1) to receive treatment with 1 of 3 study drugs for 3 months. Study drug instillation began the morning after the second eligibility visit.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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 patient, in the opinion of the Investigator, unsuitable for the study.
  • Other protocol-specified exclusion criteria may apply.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01297517

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01297517     History of Changes
Other Study ID Numbers: C-10-033
Study First Received: February 15, 2011
Results First Received: March 27, 2013
Last Updated: May 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
AOG
OHT
Open-Angle Glaucoma
Ocular Hypertension

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

ClinicalTrials.gov processed this record on May 21, 2013