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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT01310777

First received: March 7, 2011

Last updated: January 17, 2013

Last verified: January 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	March 7, 2011
Last Updated Date	January 17, 2013
Start Date ^ICMJE	May 2011
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 8, 2011)	Efficacy: mean diurnal intraocular pressure (IOP) (average over time points) change from baseline [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01310777 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Brinzolamide/Brimonidine Twice a Day (BID) Fixed Combination (FC) vs Brinzolamide BID and Brimonidine BID in Patients With Open Angle Glaucoma or Ocular Hypertension
Official Title ^ICMJE	Not Provided
Brief 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% and to brimonidine 0.2% in patients with open-angle glaucoma or ocular hypertension.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Open-angle Glaucoma Ocular Hypertension
Intervention ^ICMJE	Drug: Brinzolamide 1% / brimonidine 0.2% ophthalmic suspension Eye drops, suspension - one drop in each affected eye, twice a day Drug: Brinzolamide 1% Eye drops, suspension BID (AZOPT) Brinzolamide 1% Eye drops, suspension - one drop in each affected eye, twice a day Drug: Brimonidine Tartrate Brimonidine Tartrate 0.2% ophthalmic solution - one drop in each affected eye, twice a day
Study Arm (s)	Experimental: Brinzolamide/ Brimonidine Brinzolamide 1% / Brimonidine Tartrate 0.2% fixed combination Intervention: Drug: Brinzolamide 1% / brimonidine 0.2% ophthalmic suspension Active Comparator: Brinzolamide Brinzolamide 1% administration Intervention: Drug: Brinzolamide 1% Eye drops, suspension BID (AZOPT) Active Comparator: Brimonidine Tartrate Brimonidine Tartrate 0.2% Intervention: Drug: Brimonidine Tartrate
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	771
Completion Date	January 2013
Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 already on multiple IOP-lowering medications.Patients meeting qualifying IOP entry criteria. Patients should be able to understand and sign an informed consent 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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01310777
Other Study ID Numbers ^ICMJE	C-10-040, 2010-024512-34
Has Data Monitoring Committee	No
Responsible Party	Alcon Research
Study Sponsor ^ICMJE	Alcon Research
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Alcon Research
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top