Conditions: Open-Angle Glaucoma Ocular Hypertension
Keywords: Open-angle glaucoma (OAG) Ocular hypertension (OHT) AZORGA® COSOPT®
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 218
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate AZORGA® Ophthalmic Suspension compared to COSOPT® Ophthalmic Solution for IOP-lowering efficacy in subjects with open-angle glaucoma or ocular hypertension.

Detailed description:
After the screening examination, subjects were enrolled in the study and moved into the observation period. During the observation period, prostaglandin-analog (PGA) monotherapy was applied. After the observation period of 4 weeks or more, the baseline examination was performed. Subjects were then randomized and moved into the treatment period.

Arms:
arm 1: Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks. arm 2: Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.

Interventions: intervention 1: Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension intervention 2: Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution intervention 3: Subject's habitual PGA monotherapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: