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
2 other identifiers
interventional
35
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 2009
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2008
CompletedFirst Posted
Study publicly available on registry
December 2, 2008
CompletedStudy Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedResults Posted
Study results publicly available
March 22, 2013
CompletedMarch 22, 2013
March 1, 2013
2.9 years
December 1, 2008
January 31, 2013
March 20, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Week 0, Week 6 (period-based)
Secondary Outcomes (11)
Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6
Week 0, Week 6 (period-based)
Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6
Week 0, Week 6 (period-based)
Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6
Week 0, Week 6 (period-based)
Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6
Week 0, Week 6 (period-based)
Mean Change From Baseline in Diastolic Blood Pressure at Week 6
Week 0, Week 6 (period-based)
- +6 more secondary outcomes
Study Arms (2)
AZARGA/COMBIGAN
OTHERAZARGA, 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.
COMBIGAN/AZARGA
OTHERCOMBIGAN, 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
Fixed combination ophthalmic suspension
Fixed combination ophthalmic solution
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alcon Researchlead
Study Sites (1)
Contact Alcon Call Center at 1-888-451-3937 For Trial Locations
Fort Worth, Texas, 76134, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director, Global Medical Affairs
- Organization
- Alcon Research, Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2008
First Posted
December 2, 2008
Study Start
February 1, 2009
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
March 22, 2013
Results First Posted
March 22, 2013
Record last verified: 2013-03