Trial Outcomes & Findings for Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy (NCT NCT01263444)
NCT ID: NCT01263444
Last Updated: 2014-05-20
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. Only one eye (study eye) contributed to the mean.
COMPLETED
PHASE4
47 participants
Baseline, Week 12
2014-05-20
Participant Flow
Participants were recruited from 3 study centers located in Austria and 2 study centers located in Spain.
This reporting group includes all enrolled participants (47).
Participant milestones
| Measure |
Azarga
Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
|
|---|---|
|
Overall Study
STARTED
|
47
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Azarga
Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Safety and Efficacy of Adding AZARGA® Adjunctive to Prostaglandin Therapy
Baseline characteristics by cohort
| Measure |
Azarga
n=47 Participants
Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
|
|---|---|
|
Age, Customized
≤55 Years
|
3 participants
n=39 Participants
|
|
Age, Customized
56-65 Years
|
10 participants
n=39 Participants
|
|
Age, Customized
66-75 Years
|
25 participants
n=39 Participants
|
|
Age, Customized
≥ 76 Years
|
9 participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 12Population: This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.
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. Only one eye (study eye) contributed to the mean.
Outcome measures
| Measure |
Azarga
n=47 Participants
Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
|
|---|---|
|
Mean Change From Baseline in Intraocular Pressure (IOP) at Week 12
|
-6.0 mmHg
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Baseline, Week 12Population: This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.
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. Only prostaglandin subgroups with ≥ 15 patients were analyzed. Only one eye (study eye) contributed to the mean.
Outcome measures
| Measure |
Azarga
n=47 Participants
Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
|
|---|---|
|
Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12
AZARGA + Latanoprost (n=22)
|
-7.1 mmHg
Standard Deviation 2.9
|
|
Mean Change From Baseline in IOP Per Prostaglandin Group at Week 12
AZARGA + Travoprost (n=15)
|
-5.1 mmHg
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Baseline, Week 4Population: This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.
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. Only one eye (study eye) contributed to the mean.
Outcome measures
| Measure |
Azarga
n=47 Participants
Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
|
|---|---|
|
Mean Change From Baseline in IOP at Week 4
|
-6.0 mmHg
Standard Deviation 3.2
|
SECONDARY outcome
Timeframe: Week 12Population: This analysis population includes all patients who received study medication and had at least one on-therapy study visit minus missing responses and/or visit attendance.
IOP (fluid pressure inside the eye) was assessed using Goldmann applanation tonometry and measured in millimeters of mercury (mmHg). A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage). Only one eye (study eye) was assessed.
Outcome measures
| Measure |
Azarga
n=47 Participants
Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
|
|---|---|
|
Percentage of Patients Reaching the Target IOP (≤ 18 mmHg)
|
70.0 percentage of participants
Interval 15.9 to 18.5
|
Adverse Events
Azarga
Serious adverse events
| Measure |
Azarga
n=47 participants at risk
Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
|
|---|---|
|
General disorders
Pseudo stenocardia
|
2.1%
1/47 • Adverse events (AEs) were collected for the duration of the study (2 years, 1 month). This analysis group includes all patients who received study medication.
An AE was defined as any untoward medical occurrence in a patient who is administered a study treatment, regardless of causal relationship with the treatment. Reports of AEs were obtained through solicited and spontaneous comments from the patients and through observations by the Investigator as outlined in the study protocol.
|
Other adverse events
Adverse event data not reported
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