The purpose of this study was to compare the short term effects of two intraocular pressure (IOP) lowering medications on ocular perfusion pressure (OPP), ocular blood flow, intraocular pressure, and blood pressure in patients with glaucoma. Ocular perfusion pressure (OPP) is defined as the difference between arterial blood pressure (diastolic and systolic) and intraocular pressure. The primary efficacy assessment is based on diastolic ocular perfusion pressure.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
35
Fixed combination ophthalmic suspension
Fixed combination ophthalmic solution
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Fort Worth, Texas, United States
Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6
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).
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6
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.
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6
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.
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6
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.
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Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6
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).
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in Diastolic Blood Pressure at Week 6
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.
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in Systolic Blood Pressure at Week 6
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.
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6
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.
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks
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.
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6
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.
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6
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.
Time frame: Week 0, Week 6 (period-based)
Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6
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.
Time frame: Week 0, Week 6 (period-based)