Trial Outcomes & Findings for Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension (NCT NCT01978600)
NCT ID: NCT01978600
Last Updated: 2015-04-13
Results Overview
Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
COMPLETED
PHASE4
89 participants
Week 4: 10PM, 12AM, 2AM, 4AM, 6AM
2015-04-13
Participant Flow
Participants were recruited from 1 study center located in the US.
Of the 89 enrolled, 3 participants were exited as screen failures prior to randomization. This reporting group includes all randomized participants (86).
Participant milestones
| Measure |
Simbrinza
1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
|
Timolol
1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
44
|
42
|
|
Overall Study
COMPLETED
|
44
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of Intraocular Pressure Using Simbrinza™ in Patients With Open-Angle Glaucoma or Ocular Hypertension
Baseline characteristics by cohort
| Measure |
Simbrinza
n=44 Participants
1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
|
Timolol
n=42 Participants
1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
|
Total
n=86 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 10.73 • n=5 Participants
|
59.7 years
STANDARD_DEVIATION 11.14 • n=7 Participants
|
60.1 years
STANDARD_DEVIATION 10.87 • n=5 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 4: 10PM, 12AM, 2AM, 4AM, 6AMPopulation: This analysis population includes all participants who received study medication and had at least one on-therapy study visit.
Nocturnal IOP (fluid pressure inside the eye) is the mean of the nocturnal time points assessed (10 PM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Outcome measures
| Measure |
Simbrinza
n=44 Participants
1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
|
Timolol
n=42 Participants
1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
|
|---|---|---|
|
Mean Nocturnal IOP at Week 4
Baseline (Day 0)
|
24.2 mmHg
Standard Deviation 4.01
|
23.6 mmHg
Standard Deviation 3.31
|
|
Mean Nocturnal IOP at Week 4
Week 4
|
18.6 mmHg
Standard Deviation 3.61
|
18.9 mmHg
Standard Deviation 2.93
|
SECONDARY outcome
Timeframe: Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PMPopulation: This analysis population includes all participants who received study medication and had at least one on-therapy study visit.
Diurnal IOP (fluid pressure inside the eye) is the mean of the diurnal time points assessed (8 AM to 8 PM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Outcome measures
| Measure |
Simbrinza
n=44 Participants
1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
|
Timolol
n=42 Participants
1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
|
|---|---|---|
|
Mean Diurnal IOP at Week 4
Baseline (Day 0)
|
23.2 mmHg
Standard Deviation 3.17
|
22.2 mmHg
Standard Deviation 2.97
|
|
Mean Diurnal IOP at Week 4
Week 4
|
17.3 mmHg
Standard Deviation 3.01
|
17.7 mmHg
Standard Deviation 2.90
|
SECONDARY outcome
Timeframe: Week 4: 8AM, 10AM, 12PM, 2PM, 4PM, 6PM, 8PM, 10PM, 12AM, 2AM, 4AM, 6AMPopulation: This analysis population includes all participants who received study medication and had at least one on-therapy study visit.
24-hour IOP (fluid pressure inside the eye) is the mean of all the time points assessed (8 AM to 6 AM). IOP was measured with a calibrated applanation tonometer in millimeters of mercury (mmHg). One eye from each subject was chosen as the study eye and only data for the study eye were used for the efficacy analysis. A higher IOP can be a greater risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Outcome measures
| Measure |
Simbrinza
n=44 Participants
1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
|
Timolol
n=42 Participants
1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
|
|---|---|---|
|
Mean 24-hour IOP at Week 4
Baseline (Day 0)
|
23.6 mmHg
Standard Deviation 3.30
|
22.8 mmHg
Standard Deviation 2.84
|
|
Mean 24-hour IOP at Week 4
Week 4
|
17.9 mmHg
Standard Deviation 3.06
|
18.2 mmHg
Standard Deviation 2.63
|
Adverse Events
Simbrinza
Timolol
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Doug Hubatsch, Global Brand Leader, Medical Affairs, Glaucoma
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