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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

Page last updated: December 08, 2011

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