- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00800540
Circadian Ocular Perfusion Pressure and Ocular Blood Flow
March 20, 2013 updated by: Alcon Research
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
35
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Fort Worth, Texas, United States, 76134
- Contact Alcon Call Center at 1-888-451-3937 for Trial Locations
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: 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.
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Fixed combination ophthalmic suspension
Other Names:
Fixed combination ophthalmic solution
Other Names:
|
OTHER: 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.
|
Fixed combination ophthalmic suspension
Other Names:
Fixed combination ophthalmic solution
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6
Time Frame: Week 0, Week 6 (period-based)
|
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).
|
Week 0, Week 6 (period-based)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6
Time Frame: Week 0, Week 6 (period-based)
|
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.
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Week 0, Week 6 (period-based)
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Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6
Time Frame: Week 0, Week 6 (period-based)
|
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.
|
Week 0, Week 6 (period-based)
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Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6
Time Frame: Week 0, Week 6 (period-based)
|
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.
|
Week 0, Week 6 (period-based)
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Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6
Time Frame: Week 0, Week 6 (period-based)
|
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).
|
Week 0, Week 6 (period-based)
|
Mean Change From Baseline in Diastolic Blood Pressure at Week 6
Time Frame: Week 0, Week 6 (period-based)
|
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.
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Week 0, Week 6 (period-based)
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Mean Change From Baseline in Systolic Blood Pressure at Week 6
Time Frame: Week 0, Week 6 (period-based)
|
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.
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Week 0, Week 6 (period-based)
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Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6
Time Frame: Week 0, Week 6 (period-based)
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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.
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Week 0, Week 6 (period-based)
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Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks
Time Frame: Week 0, Week 6 (period-based)
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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.
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Week 0, Week 6 (period-based)
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Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6
Time Frame: Week 0, Week 6 (period-based)
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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.
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Week 0, Week 6 (period-based)
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Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6
Time Frame: Week 0, Week 6 (period-based)
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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.
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Week 0, Week 6 (period-based)
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Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6
Time Frame: Week 0, Week 6 (period-based)
|
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.
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Week 0, Week 6 (period-based)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2009
Primary Completion (ACTUAL)
January 1, 2012
Study Completion (ACTUAL)
January 1, 2012
Study Registration Dates
First Submitted
December 1, 2008
First Submitted That Met QC Criteria
December 1, 2008
First Posted (ESTIMATE)
December 2, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
March 22, 2013
Last Update Submitted That Met QC Criteria
March 20, 2013
Last Verified
March 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Ocular Hypertension
- Glaucoma
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Antihypertensive Agents
- Enzyme Inhibitors
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Carbonic Anhydrase Inhibitors
- Pharmaceutical Solutions
- Timolol
- Brimonidine Tartrate
- Ophthalmic Solutions
- Brinzolamide
Other Study ID Numbers
- C-07-16
- 2007-005936-99 (EUDRACT_NUMBER)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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