Circadian Ocular Perfusion Pressure and Ocular Blood Flow

Alcon

Status and phase: Completed; Phase 4

Conditions: Glaucoma

Treatments: Drug: Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension; Drug: Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00800540

2007-005936-99 (EudraCT Number)

C-07-16

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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35 participants in 2 patient groups

AZARGA/COMBIGAN

Other group

Description:

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.

Treatment:

Drug: Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution

Drug: Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension

COMBIGAN/AZARGA

Other group

Description:

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.

Treatment:

Drug: Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution

Drug: Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension