An adaptive, multi-center, randomized, investigator-masked,subject-masked, multiple-dose, placebo-controlled, parallel study toinvestigate efficacy, safety, tolerability and pharmacokinetics ofRO5093151 for up to 28 days in subjects with primary open angleglaucoma or ocular hypertension.

F. Hoffmann-La Roche Ltd.0 sites60 target enrollmentNovember 3, 2011

Overview

No summary available.

Registry

who.int

Start Date

November 3, 2011

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\* Male and female subjects, at least 21 years of age, inclusive.
•\* Diagnosis of ocular hypertension or primary open angle glaucoma in at least one eye.
•\* Subject with intraocular hypertension must have an IOP \= 22 mm Hg at the 8:00 AM (± 1 h) and \= 18 mm Hg in the afternoon measurement in at least one eye and \= 32 mm Hg at all time points in both eyes, at screening and on Day \-7\.
•\* Subject with diagnosed glaucoma must have an IOP \= 18 mm at screening and \= 22 mm Hg on Day \-7, at the 8:00 AM and the afternoon measurement in at least one eye.
•\* Best corrected visual acuity score of 6/30 (20/100 Snellen, 0\.7 LogMar) or better in each eye as measured by ETDRS visual acuity test at screening.
•\* Central corneal pachymetry measurement 420 to 620 µ in qualifying eye at screening.
•\* Cup\-to\-disk ratio \= 0\.8\.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes

•\* Presence of extreme narrow angle with complete or partial closure, as measured by gonioscopy or at risk for angle closure.
•\* History or signs of penetrating ocular trauma in either eye less than 6 months prior to randomization or intraocular laser procedures less than 3 months prior to randomization.
•\* Risk of visual field or visual acuity worsening in either eye as a consequence of glaucoma progression or consequence of participation in the trial or any other ocular disease.
•\* History of any ocular filtering surgical intervention OR previous glaucoma intraocular surgery in study eye(s).
•\* Any other intraocular surgery within 6 months of screening.
•\* Progressive retinal or optic nerve disease from any cause other than glaucoma.