Back to resultsAZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure
Primary Purpose
Glaucoma
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Brinzolamide 1% and timolol 0.5% fixed combination eye drops
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Open-angle glaucoma, Ocular hypertension, Pigment dispersion glaucoma
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
- Must be on a stable regimen of intra-ocular pressure (IOP) lowering medication within one week of screening/baseline visit.
- Must have an IOP of between 19 and 35 mmHg (both inclusive) in at least one eye, which would be the study eye, at screening.
- Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
- Must have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
- Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the medication to be used in the study deemed clinically significant in the opinion of the principal investigator.
- Any abnormality preventing reliable applanation tonometry in either eye.
- Risk of visual field or visual acuity worsening as a consequence of participating in this study, in the investigator's best judgment.
- Pregnant or lactating.
- Participation in any other investigational study within 30 days of screening visit.
- Other protocol-defined exclusion criteria may apply.
Sites / Locations
- Contact Alcon Call Center for Trial Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
AZARGA
Arm Description
Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
Outcomes
Primary Outcome Measures
Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only)
As measured at baseline and final visit with Goldmann applanation tonometry. The outcome measure was pre-specified for Timolol 0.5% only participants.
Secondary Outcome Measures
Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy
As measured with Goldmann applanation tonometry. The outcome measure was pre-specified for all participants.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01484951
Brief Title
AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure
Official Title
Assessing the Safety and Efficacy of Switching to AZARGA® (Brinzolamide/Timolol Fixed Combination) as Replacement Therapy in Patients With Uncontrolled Intraocular Pressure in Taiwan
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (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 safety and efficacy of switching to Azarga from prior pharmacotherapy in patients with open-angle glaucoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
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
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AZARGA
Arm Type
Experimental
Arm Description
Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Brinzolamide 1% and timolol 0.5% fixed combination eye drops
Other Intervention Name(s)
AZARGA®
Primary Outcome Measure Information:
Title
Change in Intraocular Pressure (IOP) at the Final Visit From Prior Beta-blocker Monotherapy (Timolol 0.5% Only)
Description
As measured at baseline and final visit with Goldmann applanation tonometry. The outcome measure was pre-specified for Timolol 0.5% only participants.
Time Frame
Baseline, Week 8
Secondary Outcome Measure Information:
Title
Percentage of Patients With Target IOP (≤18 mmHg), Regardless of Prior Therapy
Description
As measured with Goldmann applanation tonometry. The outcome measure was pre-specified for all participants.
Time Frame
Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of ocular hypertension, primary open-angle or pigment dispersion glaucoma in both eyes.
Must be on a stable regimen of intra-ocular pressure (IOP) lowering medication within one week of screening/baseline visit.
Must have an IOP of between 19 and 35 mmHg (both inclusive) in at least one eye, which would be the study eye, at screening.
Must be willing to discontinue the use of all other ocular hypotensive medications prior to receiving the study medication for the entire course of the study.
Must have best corrected visual acuity of 6/60 (20/200 Snellen, 1.0 LogMAR) or better in each eye.
Other protocol-defined inclusion criteria may apply.
Exclusion Criteria:
Known medical history of allergy, hypersensitivity, or poor tolerance to any component of the medication to be used in the study deemed clinically significant in the opinion of the principal investigator.
Any abnormality preventing reliable applanation tonometry in either eye.
Risk of visual field or visual acuity worsening as a consequence of participating in this study, in the investigator's best judgment.
Pregnant or lactating.
Participation in any other investigational study within 30 days of screening visit.
Other protocol-defined exclusion criteria may apply.
Facility Information:
Facility Name
Contact Alcon Call Center for Trial Locations
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76134
Country
United States
12. IPD Sharing Statement
Learn more about this trial
AZARGA Transition Study in Taiwan for Patients With Uncontrolled Intraocular Pressure
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