Efficacy and Safety of Brinzolamide 1% / Brimonidine 0.2% Fixed Combination BID vs. Brinzolamide 1% BID Plus Brimonidine 0.2% BID
Information source: Alcon Research
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Open-angle Glaucoma or Ocular Hypertension
Intervention: Brinzolamide 1% / brimonidine 0.2% ophthalmic suspension (Drug); Vehicle for masking purposes (Other); Brinzolamide 1% ophthalmic suspension (AZOPT) (Drug); Brimonidine 0.2% ophthalmic solution (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: Alcon Research Overall contact:
Alcon Call Center, Phone: 1-888-451-3937
Summary
A multi-center, double-masked, randomized parallel group efficacy and safety study of
brinzolamide 1% /brimonidine 0. 2% fixed combination compared to brinzolamide 1% plus
brimonidine 0. 2% in patients with open-angle glaucoma or ocular hypertension.
Clinical Details
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Efficacy: mean diurnal IOP (average over time points) change from baseline
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients 18 years of age or older, of either gender, and any race/ethnicity,
diagnosed with open-angle glaucoma or ocular hypertension who in the opinion of the
Investigator are insufficiently controlled on monotherapy or are currently on
multiple IOP-lowering medications.
- Patients meeting qualifying IOP entry criteria.
- Able to understand and sign an informed consent form that has been approved by an
Institutional Review Board/Independent Ethics Committee.
Exclusion Criteria:
- Schaffer angle Grade < 2
- Cup/disc ratio greater than 0. 80
- Severe central visual field loss
- Best Corrected VA score worse than 55 ETDRS letters (20/80 Snellen equivalent)
- Chronic, recurrent or severe inflammatory eye disease
- Clinically significant or progressive retinal disease
- Other ocular pathology
- Patients with recent use of high-dose (>1 gm daily) salicylate therapy
- Recent, current, or anticipated treatment with any medication that augments
adrenergic responses, or precludes use of an alpha-adrenergic agonist
Locations and Contacts
Alcon Call Center, Phone: 1-888-451-3937
Contact Alcon Call Center for Trial Locations, Fort Worth, Texas 76134, United States; Recruiting
Additional Information
Starting date: May 2011
Last updated: November 30, 2011
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