Circadian Ocular Perfusion Pressure and Ocular Blood Flow

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alcon Research
• Treatments: Brimonidine Tartrate; Brimonidine Tartrate, Timolol Maleate Drug Combination; Brinzolamide; Ophthalmic Solutions; Tetrahydrozoline; Timolol

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.