Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Latin America

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT01518244

First received: January 23, 2012

Last updated: May 2, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 23, 2012

Last Updated Date

May 2, 2013

Start Date ^ICMJE

January 2012

Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in intra-ocular pressure (IOP) at 8 weeks from baseline (prior therapy). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Goldmann applanation tonometry will be performed at the baseline visit and at the 8-week visit to record IOP. Change at 8 weeks from baseline will be calculated. IOP will be measured in mmHg.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01518244 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

Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on COMBIGAN® (Brimonidine 0.2%/Timolol 0.5% Fixed Combination) Therapy in Latin America

Official Title ^ICMJE

Assessing the Efficacy and Tolerability of AZARGA® (Brinzolamide 1%/Timolol 0.5% Fixed Combination) as Replacement Therapy in Patients on Brimonidine 0.2%/Timolol 0.5% Fixed Combination Therapy (COMBIGAN®) in Latin America

Brief Summary

The objective of this study is to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in patients with open-angle glaucoma or ocular hypertension.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Glaucoma

Intervention ^ICMJE

Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)

Commercially marketed topical ocular agent for the treatment of open-angle glaucoma (OAG) or ocular hypertension.

Other Name: AZARGA®

Study Arm (s)

Experimental: AZARGA

One drop self-administered in study eye(s) twice a day for 8 weeks

Intervention: Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)

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

Completion Date

February 2013

Primary Completion Date

February 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

18 years of age or older.
Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
Be on a stable IOP (intra-ocular pressure) lowering regimen within 30 days of the Screening Visit.
IOP considered safe in both eyes in such a way that should assure clinical stability of vision and optic nerve throughout the study period.
Best corrected visual acuity of 6/60 (20/200 Snellen; 1.0 LogMAR) or better in each eye.
IOP between 19 and 35 mmHG in at least one eye (which would be the study eye) while on brimonidine/timolol fixed combination therapy.
Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

Presence of other primary or secondary glaucoma not listed in inclusion criteria #2.
History of ocular herpes simplex.
Abnormality preventing reliable applanation tonometry.
Corneal dystrophies.
Concurrent infectious/noninfectious conjunctivitis, keratitis, or uveitis in either eye. Blepharitis or non-clinically significant conjunctival injection is allowed.
Intraocular conventional surgery or laser surgery in study eye(s) less than three months prior to the Screening Visit.
Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the investigator's best judgment.
Progressive retinal or optic nerve disease from any cause.
Use of systemic medications known to affect IOP which have not been on a stable course for 7 days prior to the Screening Visit or an anticipated change in the dosage during the course of the studyl.
Pregnant or lactating.
Other protocol-defined exclusion criteria may apply.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01518244

Other Study ID Numbers ^ICMJE

RDG-11-198

Has Data Monitoring Committee

Responsible Party

Alcon Research

Study Sponsor ^ICMJE

Alcon Research

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Abayomi Ogundele, PharmD

Alcon Research

Information Provided By

Alcon Research

Verification Date

May 2013

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

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