Trial Outcomes & Findings for Circadian Ocular Perfusion Pressure and Ocular Blood Flow (NCT NCT00800540)
NCT ID: NCT00800540
Last Updated: 2013-03-22
Results Overview
Diastolic ocular perfusion pressure (DOPP) is defined as the difference between diastolic arterial pressure and intraocular pressure. Diastolic arterial pressure was measured with a calibrated automated sphygmomanometer. Intraocular pressure was measured with a calibrated pneumatonometer. A lower DOPP indicates a lower optic blood supply, which can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
COMPLETED
PHASE4
35 participants
Week 0, Week 6 (period-based)
2013-03-22
Participant Flow
Participants were recruited from and enrolled at one study center located in Greece.
Participant milestones
| Measure |
AZARGA/COMBIGAN
AZARGA, followed by COMBIGAN, as randomized. Each fixed combination was used for 6 weeks, with a 4-week washout period separating the two treatment periods.
|
COMBIGAN/AZARGA
COMBIGAN, followed by AZARGA, as randomized. Each fixed combination was used for 6 weeks, with a 4-week washout period separating the two treatment periods.
|
|---|---|---|
|
Period One: 6 Weeks
STARTED
|
17
|
18
|
|
Period One: 6 Weeks
COMPLETED
|
16
|
17
|
|
Period One: 6 Weeks
NOT COMPLETED
|
1
|
1
|
|
Washout: 4 Weeks
STARTED
|
16
|
17
|
|
Washout: 4 Weeks
COMPLETED
|
16
|
17
|
|
Washout: 4 Weeks
NOT COMPLETED
|
0
|
0
|
|
Period 2: 6 Weeks
STARTED
|
16
|
17
|
|
Period 2: 6 Weeks
COMPLETED
|
16
|
16
|
|
Period 2: 6 Weeks
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
AZARGA/COMBIGAN
AZARGA, followed by COMBIGAN, as randomized. Each fixed combination was used for 6 weeks, with a 4-week washout period separating the two treatment periods.
|
COMBIGAN/AZARGA
COMBIGAN, followed by AZARGA, as randomized. Each fixed combination was used for 6 weeks, with a 4-week washout period separating the two treatment periods.
|
|---|---|---|
|
Period One: 6 Weeks
Noncompliance
|
1
|
0
|
|
Period One: 6 Weeks
Pt Decision Unrelated to Adverse Event
|
0
|
1
|
|
Period 2: 6 Weeks
Adverse Event
|
0
|
1
|
Baseline Characteristics
Circadian Ocular Perfusion Pressure and Ocular Blood Flow
Baseline characteristics by cohort
| Measure |
Overall
n=35 Participants
All enrolled
|
|---|---|
|
Age Continuous
|
65.2 years
STANDARD_DEVIATION 10.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
35 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 6 (period-based)Population: This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).
Diastolic ocular perfusion pressure (DOPP) is defined as the difference between diastolic arterial pressure and intraocular pressure. Diastolic arterial pressure was measured with a calibrated automated sphygmomanometer. Intraocular pressure was measured with a calibrated pneumatonometer. A lower DOPP indicates a lower optic blood supply, which can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Outcome measures
| Measure |
AZARGA
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
COMBIGAN
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
|---|---|---|
|
Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6
|
2.6 mmHg (millimeters of mercury)
Standard Error 0.780
|
0.8 mmHg (millimeters of mercury)
Standard Error 0.779
|
SECONDARY outcome
Timeframe: Week 0, Week 6 (period-based)Population: This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).
Circadian diastolic ocular perfusion pressure (COPP) is defined as the variations in diastolic OPP during the day and night. Diastolic ocular perfusion pressure was calculated at 7 timepoints over a 24-hour period. Changes in the diastolic ocular perfusion pressure rhythm throughout the day (outside the normal range) may affect glaucoma progression.
Outcome measures
| Measure |
AZARGA
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
COMBIGAN
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
|---|---|---|
|
Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6
9:00 am
|
2.8 mmHg (millimeters of mercury)
Standard Error 1.282
|
6.5 mmHg (millimeters of mercury)
Standard Error 1.282
|
|
Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6
1:00 pm
|
3.0 mmHg (millimeters of mercury)
Standard Error 1.282
|
2.1 mmHg (millimeters of mercury)
Standard Error 1.282
|
|
Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6
5:00 pm
|
4.4 mmHg (millimeters of mercury)
Standard Error 1.282
|
3.9 mmHg (millimeters of mercury)
Standard Error 1.282
|
|
Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6
9:00 pm
|
4.5 mmHg (millimeters of mercury)
Standard Error 1.282
|
2.0 mmHg (millimeters of mercury)
Standard Error 1.282
|
|
Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6
12:00 am
|
0.8 mmHg (millimeters of mercury)
Standard Error 1.282
|
-5.6 mmHg (millimeters of mercury)
Standard Error 1.282
|
|
Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6
3:00 am
|
0.3 mmHg (millimeters of mercury)
Standard Error 1.282
|
-4.0 mmHg (millimeters of mercury)
Standard Error 1.282
|
|
Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6
6:00 am
|
2.0 mmHg (millimeters of mercury)
Standard Error 1.296
|
0.9 mmHg (millimeters of mercury)
Standard Error 1.282
|
SECONDARY outcome
Timeframe: Week 0, Week 6 (period-based)Population: This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.
Retinal perfusion assessments were made using Heidelberg Retinal Flowmetry (HRF). Assessments were made at 4 timepoints over a 12-hour period. Intensity of blood flow was measured in arbitrary units, with a higher number indicating an increased blood flow. An increase in ocular blood flow may reduce the risk of glaucoma progression.
Outcome measures
| Measure |
AZARGA
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
COMBIGAN
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
|---|---|---|
|
Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6
9:00 am
|
-272.4 Arbitrary Units
Standard Error 146.294
|
-43.5 Arbitrary Units
Standard Error 146.586
|
|
Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6
1:00 pm
|
-12.1 Arbitrary Units
Standard Error 142.844
|
248.9 Arbitrary Units
Standard Error 144.917
|
|
Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6
5:00 pm
|
-26.7 Arbitrary Units
Standard Error 144.914
|
-51.3 Arbitrary Units
Standard Error 142.844
|
|
Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6
9:00 pm
|
14.0 Arbitrary Units
Standard Error 148.317
|
-33.2 Arbitrary Units
Standard Error 144.451
|
SECONDARY outcome
Timeframe: Week 0, Week 6 (period-based)Population: This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.
Retinal perfusion assessments were made using Heidelberg Retinal Flowmetry (HRF). Assessments were made at 4 timepoints over a 12-hour period. Intensity of blood flow was measured in arbitrary units, with a higher number indicating an increased blood flow. An increase in ocular blood flow may reduce the risk of glaucoma progression.
Outcome measures
| Measure |
AZARGA
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
COMBIGAN
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
|---|---|---|
|
Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6
9:00 am
|
15.9 Arbitrary Units
Standard Error 92.064
|
-70.0 Arbitrary Units
Standard Error 89.642
|
|
Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6
1:00 pm
|
-40.7 Arbitrary Units
Standard Error 89.642
|
-89.2 Arbitrary Units
Standard Error 95.324
|
|
Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6
5:00 pm
|
-38.7 Arbitrary Units
Standard Error 88.363
|
-69.1 Arbitrary Units
Standard Error 92.610
|
|
Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6
9:00 pm
|
182.3 Arbitrary Units
Standard Error 92.064
|
-91.0 Arbitrary Units
Standard Error 92.064
|
SECONDARY outcome
Timeframe: Week 0, Week 6 (period-based)Population: This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).
Intraocular pressure (IOP) is defined as the fluid pressure inside the eye. Intraocular pressure was measured with a calibrated pneumatonometer at 7 time points over a 24-hour period. High IOP (outside the normal range) can be a risk factor for developing glaucoma or glaucoma progression (leading to optic nerve damage).
Outcome measures
| Measure |
AZARGA
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
COMBIGAN
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
|---|---|---|
|
Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6
9:00 am
|
-6.3 mmHg (millimeters of mercury)
Standard Error 0.661
|
-6.5 mmHg (millimeters of mercury)
Standard Error 0.661
|
|
Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6
1:00 pm
|
-6.0 mmHg (millimeters of mercury)
Standard Error 0.661
|
-6.5 mmHg (millimeters of mercury)
Standard Error 0.661
|
|
Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6
5:00 pm
|
-5.6 mmHg (millimeters of mercury)
Standard Error 0.661
|
-5.2 mmHg (millimeters of mercury)
Standard Error 0.661
|
|
Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6
9:00 pm
|
-4.3 mmHg (millimeters of mercury)
Standard Error 0.661
|
-4.9 mmHg (millimeters of mercury)
Standard Error 0.661
|
|
Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6
12:00 am
|
-1.9 mmHg (millimeters of mercury)
Standard Error 0.661
|
-1.6 mmHg (millimeters of mercury)
Standard Error 0.661
|
|
Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6
3:00 am
|
-1.3 mmHg (millimeters of mercury)
Standard Error 0.661
|
-0.6 mmHg (millimeters of mercury)
Standard Error 0.661
|
|
Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6
6:00 am
|
-2.3 mmHg (millimeters of mercury)
Standard Error 0.668
|
-1.2 mmHg (millimeters of mercury)
Standard Error 0.661
|
SECONDARY outcome
Timeframe: Week 0, Week 6 (period-based)Population: This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).
Blood pressure is defined as the pressure exerted by circulating blood upon the walls of the blood vessels, that is, arterial pressure of the systemic circulation of blood. Diastolic blood pressure refers to the minimum pressure, that is, the pressure between heartbeats. Diastolic glood pressure was measured at 7 timepoints in a 24-hour period using a calibrated sphygmomonometer. Higher blood pressure (outside the normal range) can be a risk factor for developing cardiovascular events, such as heart attack, stroke, or heart failure. Lower blood pressure (outside the normal range) can be a risk factor for dizziness or fainting.
Outcome measures
| Measure |
AZARGA
n=32 Participants
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
COMBIGAN
n=32 Participants
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
|---|---|---|
|
Mean Change From Baseline in Diastolic Blood Pressure at Week 6
9:00 am
|
-3.3 mmHg (millimeters of mercury)
Standard Error 1.315
|
0.6 mmHg (millimeters of mercury)
Standard Error 1.315
|
|
Mean Change From Baseline in Diastolic Blood Pressure at Week 6
1:00 pm
|
-3.5 mmHg (millimeters of mercury)
Standard Error 1.315
|
-4.3 mmHg (millimeters of mercury)
Standard Error 1.315
|
|
Mean Change From Baseline in Diastolic Blood Pressure at Week 6
5:00 pm
|
-1.5 mmHg (millimeters of mercury)
Standard Error 1.315
|
-0.9 mmHg (millimeters of mercury)
Standard Error 1.315
|
|
Mean Change From Baseline in Diastolic Blood Pressure at Week 6
9:00 pm
|
-0.5 mmHg (millimeters of mercury)
Standard Error 1.315
|
-2.1 mmHg (millimeters of mercury)
Standard Error 1.315
|
|
Mean Change From Baseline in Diastolic Blood Pressure at Week 6
12:00 am
|
-1.4 mmHg (millimeters of mercury)
Standard Error 1.315
|
-7.3 mmHg (millimeters of mercury)
Standard Error 1.315
|
|
Mean Change From Baseline in Diastolic Blood Pressure at Week 6
3:00 am
|
-1.5 mmHg (millimeters of mercury)
Standard Error 1.315
|
-3.8 mmHg (millimeters of mercury)
Standard Error 1.315
|
|
Mean Change From Baseline in Diastolic Blood Pressure at Week 6
6:00 am
|
-0.5 mmHg (millimeters of mercury)
Standard Error 1.334
|
-0.7 mmHg (millimeters of mercury)
Standard Error 1.315
|
SECONDARY outcome
Timeframe: Week 0, Week 6 (period-based)Population: This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT).
Blood pressure is defined as the pressure exerted by circulating blood upon the walls of the blood vessels, that is, arterial pressure of the systemic circulation of blood. Systolic blood pressure refers to the maximum pressure, that is, the pressure while the heart is beating, and was measured at 7 timepoints in a 24-hour period using a calibrated sphygmomonometer. Higher blood pressure (outside the normal range) can be a risk factor for developing cardiovascular events, such as heart attack, stroke, or heart failure. Lower blood pressure (outside the normal range) can be a risk factor for dizziness or fainting.
Outcome measures
| Measure |
AZARGA
n=32 Participants
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
COMBIGAN
n=32 Participants
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
|---|---|---|
|
Mean Change From Baseline in Systolic Blood Pressure at Week 6
9:00 pm
|
-1.4 mmHg (millimeters of mercury)
Standard Error 2.134
|
-0.6 mmHg (millimeters of mercury)
Standard Error 2.134
|
|
Mean Change From Baseline in Systolic Blood Pressure at Week 6
12:00 am
|
-2.9 mmHg (millimeters of mercury)
Standard Error 2.134
|
-12.2 mmHg (millimeters of mercury)
Standard Error 2.134
|
|
Mean Change From Baseline in Systolic Blood Pressure at Week 6
3:00 am
|
-2.9 mmHg (millimeters of mercury)
Standard Error 2.134
|
-3.0 mmHg (millimeters of mercury)
Standard Error 2.134
|
|
Mean Change From Baseline in Systolic Blood Pressure at Week 6
6:00 am
|
-0.1 mmHg (millimeters of mercury)
Standard Error 2.165
|
3.0 mmHg (millimeters of mercury)
Standard Error 2.134
|
|
Mean Change From Baseline in Systolic Blood Pressure at Week 6
9:00 am
|
-4.2 mmHg (millimeters of mercury)
Standard Error 2.134
|
4.5 mmHg (millimeters of mercury)
Standard Error 2.134
|
|
Mean Change From Baseline in Systolic Blood Pressure at Week 6
1:00 pm
|
-2.6 mmHg (millimeters of mercury)
Standard Error 2.134
|
-1.9 mmHg (millimeters of mercury)
Standard Error 2.134
|
|
Mean Change From Baseline in Systolic Blood Pressure at Week 6
5:00 pm
|
-2.9 mmHg (millimeters of mercury)
Standard Error 2.134
|
-0.4 mmHg (millimeters of mercury)
Standard Error 2.134
|
SECONDARY outcome
Timeframe: Week 0, Week 6 (period-based)Population: This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.
Vascular resistance in the central retinal artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.
Outcome measures
| Measure |
AZARGA
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
COMBIGAN
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
|---|---|---|
|
Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6
9:00 am
|
-0.00 cm/s (centimeters per second)
Standard Error 0.014
|
0.01 cm/s (centimeters per second)
Standard Error 0.014
|
|
Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6
1:00 pm
|
-0.01 cm/s (centimeters per second)
Standard Error 0.014
|
0.01 cm/s (centimeters per second)
Standard Error 0.014
|
|
Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6
5:00 pm
|
0.00 cm/s (centimeters per second)
Standard Error 0.014
|
-0.00 cm/s (centimeters per second)
Standard Error 0.014
|
|
Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6
9:00 pm
|
0.00 cm/s (centimeters per second)
Standard Error 0.014
|
0.02 cm/s (centimeters per second)
Standard Error 0.014
|
|
Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6
12:00 am
|
0.02 cm/s (centimeters per second)
Standard Error 0.014
|
-0.01 cm/s (centimeters per second)
Standard Error 0.014
|
|
Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6
3:00 am
|
0.01 cm/s (centimeters per second)
Standard Error 0.014
|
0.01 cm/s (centimeters per second)
Standard Error 0.014
|
|
Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6
6:00 am
|
-0.02 cm/s (centimeters per second)
Standard Error 0.014
|
0.02 cm/s (centimeters per second)
Standard Error 0.014
|
SECONDARY outcome
Timeframe: Week 0, Week 6 (period-based)Population: This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.
Vascular resistance in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.
Outcome measures
| Measure |
AZARGA
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
COMBIGAN
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
|---|---|---|
|
Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks
9:00 am
|
-0.01 cm/s (centimeters per second)
Standard Error 0.012
|
-0.01 cm/s (centimeters per second)
Standard Error 0.011
|
|
Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks
1:00 pm
|
0.02 cm/s (centimeters per second)
Standard Error 0.012
|
0.02 cm/s (centimeters per second)
Standard Error 0.012
|
|
Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks
5:00 pm
|
0.01 cm/s (centimeters per second)
Standard Error 0.012
|
0.01 cm/s (centimeters per second)
Standard Error 0.012
|
|
Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks
9:00 pm
|
0.01 cm/s (centimeters per second)
Standard Error 0.012
|
0.01 cm/s (centimeters per second)
Standard Error 0.011
|
|
Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks
12:00 am
|
-0.01 cm/s (centimeters per second)
Standard Error 0.012
|
0.02 cm/s (centimeters per second)
Standard Error 0.012
|
|
Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks
3:00 am
|
0.01 cm/s (centimeters per second)
Standard Error 0.012
|
0.03 cm/s (centimeters per second)
Standard Error 0.012
|
|
Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks
6:00 am
|
0.01 cm/s (centimeters per second)
Standard Error 0.012
|
0.03 cm/s (centimeters per second)
Standard Error 0.011
|
SECONDARY outcome
Timeframe: Week 0, Week 6 (period-based)Population: This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.
End diastolic velocity in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.
Outcome measures
| Measure |
AZARGA
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
COMBIGAN
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
|---|---|---|
|
Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6
9:00 am
|
-0.0 cm/s (centimeters per second)
Standard Error 0.454
|
-0.8 cm/s (centimeters per second)
Standard Error 0.448
|
|
Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6
1:00 pm
|
-0.6 cm/s (centimeters per second)
Standard Error 0.459
|
-1.2 cm/s (centimeters per second)
Standard Error 0.460
|
|
Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6
5:00 pm
|
0.5 cm/s (centimeters per second)
Standard Error 0.459
|
0.2 cm/s (centimeters per second)
Standard Error 0.466
|
|
Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6
9:00 pm
|
0.4 cm/s (centimeters per second)
Standard Error 0.454
|
-0.8 cm/s (centimeters per second)
Standard Error 0.448
|
|
Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6
12:00 am
|
-0.8 cm/s (centimeters per second)
Standard Error 0.466
|
-1.4 cm/s (centimeters per second)
Standard Error 0.454
|
|
Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6
3:00 am
|
-0.1 cm/s (centimeters per second)
Standard Error 0.454
|
-0.6 cm/s (centimeters per second)
Standard Error 0.459
|
|
Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6
6:00 am
|
-0.2 cm/s (centimeters per second)
Standard Error 0.466
|
-0.5 cm/s (centimeters per second)
Standard Error 0.448
|
SECONDARY outcome
Timeframe: Week 0, Week 6 (period-based)Population: This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.
Peak systolic velocity in the ophthalmic artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.
Outcome measures
| Measure |
AZARGA
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
COMBIGAN
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
|---|---|---|
|
Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6
6:00 am
|
-0.6 cm/s (centimeters per second)
Standard Error 1.267
|
1.5 cm/s (centimeters per second)
Standard Error 1.221
|
|
Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6
9:00 am
|
-1.0 cm/s (centimeters per second)
Standard Error 1.237
|
-3.8 cm/s (centimeters per second)
Standard Error 1.221
|
|
Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6
1:00 pm
|
-0.7 cm/s (centimeters per second)
Standard Error 1.251
|
-1.4 cm/s (centimeters per second)
Standard Error 1.254
|
|
Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6
5:00 pm
|
2.2 cm/s (centimeters per second)
Standard Error 1.251
|
1.3 cm/s (centimeters per second)
Standard Error 1.267
|
|
Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6
9:00 pm
|
2.2 cm/s (centimeters per second)
Standard Error 1.237
|
-1.4 cm/s (centimeters per second)
Standard Error 1.221
|
|
Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6
12:00 am
|
-2.3 cm/s (centimeters per second)
Standard Error 1.268
|
-3.1 cm/s (centimeters per second)
Standard Error 1.235
|
|
Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6
3:00 am
|
0.2 cm/s (centimeters per second)
Standard Error 1.235
|
0.0 cm/s (centimeters per second)
Standard Error 1.250
|
SECONDARY outcome
Timeframe: Week 0, Week 6 (period-based)Population: This reporting group includes all patients who received study medication and completed the on-therapy follow-up study visit in both periods (ITT). The analysis is based on patient eye-matched image data received.
Peak systolic velocity in the central retinal artery was assessed using Color Doppler Imaging (CDI). Assessments were made at 7 time points over a 24-hour period.
Outcome measures
| Measure |
AZARGA
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
COMBIGAN
n=41 eyes
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
|---|---|---|
|
Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6
9:00 am
|
0.9 cm/s (centimeters per second)
Standard Error 0.571
|
0.7 cm/s (centimeters per second)
Standard Error 0.565
|
|
Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6
1:00 pm
|
-0.2 cm/s (centimeters per second)
Standard Error 0.577
|
0.3 cm/s (centimeters per second)
Standard Error 0.578
|
|
Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6
5:00 pm
|
1.0 cm/s (centimeters per second)
Standard Error 0.577
|
0.6 cm/s (centimeters per second)
Standard Error 0.565
|
|
Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6
9:00 pm
|
0.9 cm/s (centimeters per second)
Standard Error 0.565
|
-0.5 cm/s (centimeters per second)
Standard Error 0.565
|
|
Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6
12:00 am
|
1.9 cm/s (centimeters per second)
Standard Error 0.577
|
-0.5 cm/s (centimeters per second)
Standard Error 0.565
|
|
Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6
3:00 am
|
0.2 cm/s (centimeters per second)
Standard Error 0.565
|
-1.1 cm/s (centimeters per second)
Standard Error 0.570
|
|
Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6
6:00 am
|
0.2 cm/s (centimeters per second)
Standard Error 0.571
|
0.9 cm/s (centimeters per second)
Standard Error 0.565
|
Adverse Events
AZARGA
COMBIGAN
Serious adverse events
| Measure |
AZARGA
n=34 participants at risk
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
COMBIGAN
n=34 participants at risk
One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
2.9%
1/34 • Adverse events were collected for the duration of the study.
The safety population is defined as patients who received study medication.
|
0.00%
0/34 • Adverse events were collected for the duration of the study.
The safety population is defined as patients who received study medication.
|
Other adverse events
Adverse event data not reported
Additional Information
Director, Global 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