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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 Brazil

This study has been terminated.
(Low recruitment rate)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01514734
First received: January 18, 2012
Last updated: August 15, 2013
Last verified: August 2013

January 18, 2012
August 15, 2013
March 2012
August 2012   (final data collection date for primary outcome measure)
Change in Intraocular Pressure (IOP) at 8 Weeks From Baseline (Prior Therapy). [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Intraocular pressure was measured by Goldmann applanation tonometry. Data for the worse eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
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 NCT01514734 on ClinicalTrials.gov Archive Site
Not Provided
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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 Brazil
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 Brazil

The purpose of this study was to assess the efficacy and tolerability of changing to AZARGA® from prior COMBIGAN® pharmacotherapy in patients 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
Commercially marketed topical ocular agent for the treatment of open-angle glaucoma (OAG) or ocular hypertension.
Other Name: AZARGA®
Experimental: AZARGA
Brinzolamide/timolol maleate fixed combination, one 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.
 
Terminated
9
August 2012
August 2012   (final data collection date for primary outcome measure)

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 intraocular pressure (IOP) 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 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
Brazil
 
NCT01514734
RDG-11-191
No
Alcon Research
Alcon Research
Not Provided
Study Director: Doug Hubatsch, M.Sc. Alcon Research
Alcon Research
August 2013

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