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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01518244
First received: January 23, 2012
Last updated: February 25, 2014
Last verified: February 2014

January 23, 2012
February 25, 2014
December 2011
February 2013   (final data collection date for primary outcome measure)
Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8 [ Time Frame: Baseline, Week 8 ] [ Designated as safety issue: No ]
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). A more negative change indicates a greater amount of improvement. One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
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.
Complete list of historical versions of study NCT01518244 on ClinicalTrials.gov Archive Site
Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8 [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry. A higher IOP can be a greater risk for developing glaucoma or glaucoma progression (leading to optic nerve damage). One eye was chosen as the study eye, and only data from the study eye were used for the efficacy analysis.
Not Provided
Not Provided
Not Provided
 
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
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

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

Not Provided
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Glaucoma
Drug: Brinzolamide/timolol maleate fixed combination
Other Name: AZARGA®
Experimental: AZARGA®
Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
Intervention: Drug: Brinzolamide/timolol maleate fixed combination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
February 2013
February 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of ocular hypertension, exfoliative open-angle glaucoma, or pigment dispersion glaucoma in at least one eye (study eye).
  • On a stable IOP (intra-ocular pressure) lowering regimen within 30 days of Screening Visit.
  • IOP considered safe in both eyes in order to 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.
  • History of ocular herpes simplex.
  • Any 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 Screening Visit.
  • Risk of visual field or visual acuity worsening as a consequence of participation in the study, in the opinion of the investigator.
  • 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 Screening Visit or an anticipated change in the dosage during the course of the study.
  • Pregnant or lactating.
  • Other protocol-defined exclusion criteria may apply.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01518244
RDG-11-198
No
Alcon Research
Alcon Research
Not Provided
Study Director: Doug Hubatsch Alcon Research
Alcon Research
February 2014

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