Trial Outcomes & Findings for 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 (NCT NCT01518244)
NCT ID: NCT01518244
Last Updated: 2015-08-07
Results Overview
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.
COMPLETED
PHASE4
50 participants
Baseline, Week 8
2015-08-07
Participant Flow
Participants were recruited from 6 study centers located in South America: Argentina (3), Chile (1), and Mexico (2).
This reporting group includes all participants who received at least one dose of AZARGA®.
Participant milestones
| Measure |
AZARGA®
Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
47
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
AZARGA®
Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
AZARGA®
n=49 Participants
Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
|
|---|---|
|
Age, Continuous
|
66.67 years
STANDARD_DEVIATION 11.51 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 8Population: The analysis population includes all participants who received AZARGA® and with at least 1 on-therapy study visit (V2 or V3).
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.
Outcome measures
| Measure |
AZARGA®
n=49 Participants
Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
|
|---|---|
|
Mean Change in Intraocular Pressure (IOP) From Baseline (Prior Therapy) at Week 8
|
-3.60 milllimeters mercury (mmHg)
Standard Deviation 3.01
|
SECONDARY outcome
Timeframe: Week 8Population: The analysis population includes all participants who received AZARGA® and with at least 1 on-therapy study visit (V2 or V3).
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.
Outcome measures
| Measure |
AZARGA®
n=49 Participants
Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
|
|---|---|
|
Percentage of Subjects Who Reach Target IOP (≤18 mmHg) at Week 8
|
55.3 percentage of participants
|
Adverse Events
AZARGA®
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AZARGA®
n=50 participants at risk
Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
|
|---|---|
|
Eye disorders
Eye irritation
|
8.0%
4/50 • Adverse events (AEs) were collected for the duration of the study (December 2011-February 2013). An AE was defined as any untoward medical occurrence in a subject administered the test product, regardless of causal relationship with such product.
The analysis population includes all participants who received at least one dose of AZARGA®.
|
Additional Information
Doug Hubatsch, Global Brand Leader, Medical Affairs
Alcon Research, Ltd.
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
- Publication restrictions are in place
Restriction type: OTHER