This randomized, double-blind, placebo-controlled, multi-center study will evaluate the safety and the effect of RO5093151 on intraocular pressure in patients with ocular hypertension or open angle glaucoma. Patients will be randomized to receive oral doses of RO5093151 or placebo twice daily. The anticipated time on study treatment is 7 days with the possibility to extend to 28 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
Unnamed facility
Morrow, Georgia, United States
Unnamed facility
High Point, North Carolina, United States
Unnamed facility
Mt. Pleasant, South Carolina, United States
Unnamed facility
Sofia, Bulgaria
Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment
Time frame: Day 7
Change in mean daily intraocular pressure (IOP)
Time frame: Up to 28 days
Change in mean intraocular pressure (IOP) at each assessment time-points
Time frame: Up to 28 days
Change in intraocular pressure (IOP) during a placebo lead-in phase
Time frame: 7 days
Pharmacokinetics (area under the concentration time curve)
Time frame: Day 7
Urinary ratio of tetrahydrocortisol to tetrahydrocortisone
Time frame: 7 days
Safety (incidence of adverse events)
Time frame: Up to 28 days
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Unnamed facility
Hradec Králové, Czechia
Unnamed facility
Litomysi, Czechia
Unnamed facility
Prague, Czechia
Unnamed facility
Ústí nad Labem, Czechia
Unnamed facility
Zlín, Czechia
Unnamed facility
Budapest, Hungary
...and 2 more locations