Circadian Ocular Perfusion Pressure and Ocular Blood Flow

NCT ID: NCT00800540

Last Updated: 2013-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2012-01-31

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.

Conditions

Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

AZARGA/COMBIGAN

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.

Group Type: OTHER

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

Intervention Type: DRUG

Fixed combination ophthalmic suspension

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

Intervention Type: DRUG

Fixed combination ophthalmic solution

COMBIGAN/AZARGA

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.

Group Type: OTHER

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

Intervention Type: DRUG

Fixed combination ophthalmic suspension

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

Intervention Type: DRUG

Fixed combination ophthalmic solution

Interventions

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

Fixed combination ophthalmic suspension

Intervention Type: DRUG

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

Fixed combination ophthalmic solution

Intervention Type: DRUG

Other Intervention Names

AZARGA™; COMBIGAN®

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Contact Alcon Call Center at 1-888-451-3937 For Trial Locations

Fort Worth, Texas, United States

Countries

United States

Other Identifiers

2007-005936-99

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

C-07-16

Identifier Type: -

Identifier Source: org_study_id