Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Alcon Research

ClinicalTrials.gov Identifier:

NCT00966576

First received: August 26, 2009

Last updated: July 18, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	August 26, 2009
Last Updated Date	July 18, 2012
Start Date ^ICMJE	July 2009
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 12, 2012)	The mean decrease in intraocular pressure (IOP) at 12 weeks from baseline [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: August 26, 2009)	Intraocular pressure [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: Yes ]
Change History	Complete list of historical versions of study NCT00966576 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 12, 2012)	Safety as determined by visual acuity, biomicroscopy, adverse events, solicited symptom survey and treatment success [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: August 26, 2009)	Safety as determined by: visual acuity, biomicroscopy, adverse events, solicited symptom survey and treatment success [ Time Frame: Week 4 and Week 12 ] [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Efficacy and Safety of Adding Azarga to Prostaglandin Monotherapy
Official Title ^ICMJE	The Efficacy and Safety of Adding the Brinzolamide/Timolol Maleate Fixed Combination (Azarga®) to Prostaglandin Monotherapy
Brief Summary	The purpose of this study is to assess the safety and efficacy of adding AZARGA in glaucoma patients with uncontrolled intraocular pressure (IOP), currently on prostaglandin monotherapy.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 4
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Glaucoma
Intervention ^ICMJE	Drug: Brinzolamide/Timolol Maleate Fixed Combination (AZARGA) 1 drop of study medication into the study eye(s) beginning the evening of Visit 1 and continuing twice daily (morning and evening) for 12 weeks Other Name: AZARGA
Study Arm (s)	Experimental: Brinzolamide/Timolol Maleate Fixed Combination 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	47
Completion Date	August 2010
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Sign Informed Consent. 21 years of age or older. Able to follow instructions and willing to attend required study visits. Clinical diagnosis of ocular hypertension, primary open-angle, or pigment dispersion glaucoma in at least one eye (qualifying eye). Intra-ocular pressure (IOP) considered to be safe in both eyes in such a way that should assure clinical stability of vision and the optic nerve throughout the trial. Must have best corrected visual acuity of 6/60 (6/60 Snellen, 1.0 LogMAR) or better in each eye. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Presence of other primary or secondary glaucomas not listed in inclusion criterion. Presence of corneal dystrophies. Concurrent infectious/noninfectious conjunctivitis, keratitis or uveitis in either eye. Intraocular conventional surgery or laser surgery in qualifying eye(s) less than three months prior to Visit 1. Risk of visual field or visual acuity worsening as a consequence of participation in the trial, in the investigator's best judgment. Women of childbearing potential not using reliable means of birth control. Women who are pregnant or lactating. Participation in any other investigational study within 30 days prior to Visit 1. Current or anticipated use of systemic corticosteroids, by any route except inhaled, for greater than two weeks during the trial. Severe allergic rhinitis History of ocular herpes simplex. Other protocol-defined exclusion criteria may apply.
Gender	Both
Ages	21 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT00966576
Other Study ID Numbers ^ICMJE	SMA-08-22a
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	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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