Clinical trial NCT00800540: Circadian Ocular Perfusion Pressure and Ocular Blood Flow
Official title: Effects of Topical Hypotensive Drugs on Circadian Ocular Perfusion Pressure and Ocular Blood Flow in Patients With Open-Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Glaucoma
Keywords: glaucoma
ocular perfusion pressure
ocular blood flow
open angle glaucoma requiring more than one IOP-lowering medication
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-12-02
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Mean Change From Baseline in Overall Diastolic Ocular Perfusion Pressure at Week 6
timeFrame: Week 0, Week 6 (period-based)
Secondary outcomes:
measure: Mean Change From Baseline in Circadian Diastolic Ocular Perfusion Pressure at Week 6
timeFrame: Week 0, Week 6 (period-based)
measure: Mean Change From Baseline in Mean Flow Value in the Superotemporal Peripapillary Retina at Week 6
timeFrame: Week 0, Week 6 (period-based)
measure: Mean Change From Baseline in Mean Flow Value in the Inverotemporal Peripapillary Retina at Week 6
timeFrame: Week 0, Week 6 (period-based)
measure: Mean Change From Baseline in Intraocular Pressure (IOP) at Week 6
timeFrame: Week 0, Week 6 (period-based)
measure: Mean Change From Baseline in Diastolic Blood Pressure at Week 6
timeFrame: Week 0, Week 6 (period-based)
measure: Mean Change From Baseline in Systolic Blood Pressure at Week 6
timeFrame: Week 0, Week 6 (period-based)
measure: Mean Change From Baseline in Vascular Resistance in the Central Retinal Artery at Week 6
timeFrame: Week 0, Week 6 (period-based)
measure: Mean Change From Baseline in Vascular Resistance in the Ophthalmic Artery at 6 Weeks
timeFrame: Week 0, Week 6 (period-based)
measure: Mean Change From Baseline in End Diastolic Velocity in the Ophthalmic Artery at Week 6
timeFrame: Week 0, Week 6 (period-based)
measure: Mean Change From Baseline in Peak Systolic Velocity in the Ophthalmic Artery at Week 6
timeFrame: Week 0, Week 6 (period-based)
measure: Mean Change From Baseline in Peak Systolic Velocity in the Central Retinal Artery at Week 6
timeFrame: Week 0, Week 6 (period-based)
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center at 1-888-451-3937 For Trial Locations
state: Texas
Study officials:
References: