Circadian Ocular Perfusion Pressure and Ocular Blood Flow

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT00800540
First received: December 1, 2008
Last updated: March 20, 2013
Last verified: March 2013

December 1, 2008
March 20, 2013
February 2009
January 2012   (final data collection date for primary outcome measure)
Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6 [ Time Frame: Week 0, Week 6 (period-based) ] [ Designated as safety issue: No ]
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).
Diastolic ocular perfusion pressure [ Time Frame: after 6 weeks of treatment ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00800540 on ClinicalTrials.gov Archive Site
  • Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6 [ Time Frame: Week 0, Week 6 (period-based) ] [ Designated as safety issue: No ]
    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.
  • Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6 [ Time Frame: Week 0, Week 6 (period-based) ] [ Designated as safety issue: No ]
    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.
  • Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6 [ Time Frame: Week 0, Week 6 (period-based) ] [ Designated as safety issue: No ]
    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.
  • Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6 [ Time Frame: Week 0, Week 6 (period-based) ] [ Designated as safety issue: No ]
    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).
  • Mean Change From Baseline in Diastolic Blood Pressure at Week 6 [ Time Frame: Week 0, Week 6 (period-based) ] [ Designated as safety issue: No ]
    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.
  • Mean Change From Baseline in Systolic Blood Pressure at Week 6 [ Time Frame: Week 0, Week 6 (period-based) ] [ Designated as safety issue: No ]
    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.
  • Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6 [ Time Frame: Week 0, Week 6 (period-based) ] [ Designated as safety issue: No ]
    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.
  • Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks [ Time Frame: Week 0, Week 6 (period-based) ] [ Designated as safety issue: No ]
    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.
  • Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6 [ Time Frame: Week 0, Week 6 (period-based) ] [ Designated as safety issue: No ]
    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.
  • Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6 [ Time Frame: Week 0, Week 6 (period-based) ] [ Designated as safety issue: No ]
    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.
  • Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6 [ Time Frame: Week 0, Week 6 (period-based) ] [ Designated as safety issue: No ]
    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.
Circadian ocular perfusion pressure, ocular blood flow, IOP, blood pressure, ocular signs, visual acuity, dilated fundus adverse events
Not Provided
Not Provided
 
Circadian Ocular Perfusion Pressure and Ocular Blood Flow
Effects of Topical Hypotensive Drugs on Circadian Ocular Perfusion Pressure and Ocular Blood Flow in Patients With Open-Angle Glaucoma

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Glaucoma
  • Drug: Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension
    Fixed combination ophthalmic suspension
    Other Name: AZARGA™
  • Drug: Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution
    Fixed combination ophthalmic solution
    Other Name: COMBIGAN®
  • AZARGA/COMBIGAN
    AZARGA, followed by COMBIGAN, as randomized. Each fixed combination instilled in the study eye, one drop twice daily (9:00 and 21:00), for six weeks, with a 4-week washout period separating the two treatment periods.
    Interventions:
    • Drug: Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension
    • Drug: Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution
  • COMBIGAN/AZARGA
    COMBIGAN, followed by AZARGA, as randomized. Each fixed combination instilled in the study eye, one drop twice daily (9:00 and 21:00), for six weeks, with a 4-week washout period separating the two treatment periods.
    Interventions:
    • Drug: Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension
    • Drug: Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Sign Informed Consent.
  • Diagnosis of open-angle glaucoma in at least one eye.
  • Requires more than one IOP-lowering medication.
  • IOP measurements at Screening, Safety, and Eligibility/Period 1 Baseline Visits as specified in protocol.
  • Able to discontinue all IOP-lowering medication prior to Eligibility Visit and for 4 weeks between treatment periods.
  • Willing to complete all required study visits.
  • Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

  • Female of child-bearing potential if pregnant, lactating, or not using highly effective birth control measures.
  • Severe central visual field loss in either eye.
  • Previous glaucoma surgery in the study eye.
  • Intraocular surgery in the study eye within 3 months prior to the Screening Visit.
  • Wears contact lenses.
  • Allergy/hypersensitivity to study medication.
  • Cannot safely discontinue use of glucocorticoid medication.
  • Uses medication that could affect IOP or blood pressure.
  • Recent use of high-dose aspirin.
  • Bronchial asthma or severe chronic obstructive pulmonary disease.
  • Diabetic retinopathy.
  • Any abnormality preventing reliable tonometry.
  • Any severe illness or condition unsuitable for the study, in the opinion of the investigator.
  • Other protocol-defined exclusion criteria may apply.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00800540
C-07-16, 2007-005936-99
No
Alcon Research
Alcon Research
Not Provided
Not Provided
Alcon Research
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP