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

Brief Summary

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”

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.

  • 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
  • Study Primary Completion Date: January 2013

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
  • Drug: Brinzolamide 1% ophthalmic suspension
  • Drug: Brimonidine tartrate 0.2% ophthalmic solution

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Brinz/Brim
    • Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
  • Active Comparator: Brinz
    • Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
  • Active Comparator: Brim
    • Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months

Outcome Measures for this Clinical Trial

Primary Measures

  • Mean Diurnal IOP Change From Baseline at Month 3
    • Time Frame: Baseline (Day 1), Month 3
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Alcon Research
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • James Teague, Sr. Clinical Manager, Study Director, Alcon Research

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01310777