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

February 15, 2011
May 14, 2013
February 2011
March 2012   (final data collection date for primary outcome measure)
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).
Efficacy: mean Intraocular Pressure (IOP) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01297517 on ClinicalTrials.gov Archive Site
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Efficacy and Safety Study of Brinzolamide 1%/Brimonidine 0.2% vs. Brinzolamide 1% and Brimonidine 0.2%
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Open-Angle Glaucoma
  • Ocular Hypertension
  • Drug: Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension
  • Drug: Brinzolamide ophthalmic suspension, 1%
    Other Name: AZOPT®
  • Drug: Brimonidine tartrate ophthalmic solution, 0.2%
  • Experimental: Brinzolamide/Brimonidine
    Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day for 3 months
    Intervention: 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
    Intervention: Drug: Brinzolamide ophthalmic suspension, 1%
  • Active Comparator: Brimonidine
    Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day for 3 months
    Intervention: Drug: Brimonidine tartrate ophthalmic solution, 0.2%
Katz G, Dubiner H, Samples J, Vold S, Sall K. Three-month randomized trial of fixed-combination brinzolamide, 1%, and brimonidine, 0.2%. JAMA Ophthalmol. 2013 Jun;131(6):724-30. doi: 10.1001/jamaophthalmol.2013.188.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1001
March 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01297517
C-10-033
No
Alcon Research
Alcon Research
Not Provided
Study Director: James Teague, BS, Sr. Clinical Manager Alcon Research
Alcon Research
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP