Conditions: Glaucoma
Keywords: glaucoma ocular perfusion pressure ocular blood flow open angle glaucoma requiring more than one IOP-lowering medication
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 35
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Brinzolamide 10 mg/ml/Timolol 5 mg/ml eye drops suspension intervention 2: Brimonidine 20 mg/ml/Timolol 5 mg/ml eye drops solution
Intervention descriptions: intervention 1: Fixed combination ophthalmic suspension intervention 2: Fixed combination ophthalmic solution

Protocol document: