Circadian Ocular Perfusion Pressure and Ocular Blood Flow
Information source: Alcon Research
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Glaucoma
Intervention: Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension (Drug); Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Alcon Research
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.
Clinical Details
Official title: Effects of Topical Hypotensive Drugs on Circadian Ocular Perfusion Pressure and Ocular Blood Flow in Patients With Open-Angle Glaucoma
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6
Secondary outcome: Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6 Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6 Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6 Mean Change From Baseline in Diastolic Blood Pressure at Week 6 Mean Change From Baseline in Systolic Blood Pressure at Week 6 Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6 Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6 Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6 Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Contact Alcon Call Center at 1-888-451-3937 For Trial Locations, Fort Worth, Texas 76134, United States
Additional Information
Starting date: February 2009
Last updated: March 20, 2013
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