Trial Outcomes & Findings for Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma (NCT NCT03150160)
NCT ID: NCT03150160
Last Updated: 2019-02-25
Results Overview
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry in millimeters mercury (mmHg). Diurnal IOP was defined as the average of the 9:00 am and 11:00 am time points. A more negative change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.
COMPLETED
PHASE4
1 participants
Baseline, Week 6
2019-02-25
Participant Flow
All randomized patients (1). Note: No patients were randomized to the Simbrinza + Travatan arm.
Participant milestones
| Measure |
Simbrinza + Travatan
Brinzolamide 1%/brimonidine 0.2% fixed combination (morning and evening) + travoprost 0.004% ophthalmic solution (evening)
|
Placebo + Travatan
Placebo (morning and evening) + travoprost 0.004% ophthalmic solution (evening)
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
1
|
|
Overall Study
COMPLETED
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma
Baseline characteristics by cohort
| Measure |
Simbrinza + Travatan
Brinzolamide 1%/brimonidine 0.2% fixed combination (morning and evening) + travoprost 0.004% ophthalmic solution (evening)
|
Placebo + Travatan
n=1 Participants
Placebo (morning and evening) + travoprost 0.004% ophthalmic solution (evening)
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 6Population: At the time of the premature termination of this study, only 1 patient was randomized. Therefore, the planned efficacy and safety analyses could not be performed. No data to report.
IOP (fluid pressure inside the eye) was measured by Goldmann applanation tonometry in millimeters mercury (mmHg). Diurnal IOP was defined as the average of the 9:00 am and 11:00 am time points. A more negative change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 6Population: At the time of the premature termination of this study, only 1 patient was randomized. Therefore, the planned efficacy and safety analyses could not be performed. No data to report.
IOP was measured by Goldmann applanation tonometry in mmHg. A more negative percent change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 6Population: At the time of the premature termination of this study, only 1 patient was randomized. Therefore, the planned efficacy and safety analyses could not be performed. No data to report.
IOP was measured by Goldmann applanation tonometry in mmHg. Diurnal IOP was defined as the average of the 9:00 and 11:00 time points. One (study eye) contributed to the analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline (9:00 am and 11:00 am), Week 6 (9:00 am and 11:00 am)Population: At the time of the premature termination of this study, only 1 patient was randomized. Therefore, the planned efficacy and safety analyses could not be performed. No data to report.
IOP was measured by Goldmann applanation tonometry in mmHg. A more negative change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 6Population: At the time of the premature termination of this study, only 1 patient was randomized. Therefore, the planned efficacy and safety analyses could not be performed. No data to report.
IOP was measured by Goldmann applanation tonometry in mmHg. A more negative percent change value indicates a greater amount of improvement. One eye (study eye) contributed to the analysis.
Outcome measures
Outcome data not reported
Adverse Events
Simbrinza + Travatan
Placebo + Travatan
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Simbrinza + Travatan
Brinzolamide 1%/brimonidine 0.2% fixed combination (morning and evening) + travoprost 0.004% ophthalmic solution (evening)
|
Placebo + Travatan
n=1 participants at risk
Placebo (morning and evening) + travoprost 0.004% ophthalmic solution (evening)
|
|---|---|---|
|
Infections and infestations
common cold
|
—
0/0 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately six weeks.
The Safety analysis set included all patients exposed to at least one dose of any study therapy. Note: Number at risk for Simbrinza + Travatan is reported as 0 because no patients were exposed to this study therapy.
|
100.0%
1/1 • Adverse Events (AEs) were collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately six weeks.
The Safety analysis set included all patients exposed to at least one dose of any study therapy. Note: Number at risk for Simbrinza + Travatan is reported as 0 because no patients were exposed to this study therapy.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER