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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: March 2012

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Brinzolamide/Brimonidine
    • Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day for 3 months
  • Active Comparator: Brinzolamide
    • Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day for 3 months
  • Active Comparator: Brimonidine
    • Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day for 3 months

Clinical Trial Outcome Measures

Primary Measures

  • Mean IOP at Month 3 for Each Assessment Timepoint (8 AM, + 2 h, + 7 h, and + 9 h)
    • Time Frame: Month 3
    • 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

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

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