Back to resultsAssessing 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
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Brinzolamide/timolol maleate fixed combination
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Primary open angle-glaucoma, Ocular hypertension, Pigment dispersion glaucoma
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AZARGA®
Arm Description
Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
Outcomes
Primary Outcome Measures
Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8
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.
Secondary Outcome Measures
Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01518244
Brief Title
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
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alcon Research
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Primary open angle-glaucoma, Ocular hypertension, Pigment dispersion glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AZARGA®
Arm Type
Experimental
Arm Description
Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
Intervention Type
Drug
Intervention Name(s)
Brinzolamide/timolol maleate fixed combination
Other Intervention Name(s)
AZARGA®
Primary Outcome Measure Information:
Title
Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8
Description
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.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8
Description
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.
Time Frame
Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Doug Hubatsch
Organizational Affiliation
Alcon Research
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
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
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