Conditions: Glaucoma Ocular Hypertension
Keywords: Tafluprost Glaucoma Ocular Hypertension Timolol Eye Disorder Preservative-Free Prostaglandin Analogue
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 190
Healthy volunteers: no

Brief summary:
This study will test the hypothesis that preservative-free tafluprost (MK-2452) is non-inferior to preservative-free timolol maleate with respect to the diurnal intraocular pressure (IOP) change from baseline after 4 weeks of therapy in participants with open-angle glaucoma or ocular hypertension.

Detailed description:

Arms:
arm 1: One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks. Morning dose with vehicle only allows blinding to match twice daily dosing of comparator arm. arm 2: One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.

Interventions: intervention 1: Preservative-Free Tafluprost or vehicle intervention 2: Preservative-Free Timolol maleate
Intervention descriptions: intervention 1: Preservative-free tafluprost (0.0015%) ophthalmic solution; Preservative-free vehicle ophthalmic solution (contains no active drug) intervention 2: Preservative-free timolol maleate (0.5%) ophthalmic solution

Protocol document: