Primary open angle glaucoma or ocular hypertension MedDRA version: 14.0 Level: PT Classification code 10030043 Term: Ocular hypertension System Organ Class: 10015919 - Eye disorders MedDRA version: 14.0 Level: PT Classification code 10030348 Term: Open angle glaucoma System Organ Class: 10015919 - Eye disorders
Conditions
Interventions
Product Code: Ro 509-3151/F06
Pharmaceutical Form: Tablet
Current Sponsor code: RO5093151
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-
Pharmaceutical form o
Sponsors
F. Hoffmann-La Roche Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: * 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 F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 45
Exclusion criteria
Exclusion criteria: * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect of RO5093151 on intraocular pressure.;Secondary Objective: To assess the safety, tolerability, pharmacokinetics of RO5093151 following multiple dose.;Primary end point(s): Change from baseline in mean IOP at 1 h post-dose following 7 days of treatment.;Timepoint(s) of evaluation of this end point: time-matched 1 h postdose on Day -1 and Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: time-matched predose, 0 h, 1 h, 2 h, 4 h, 8 h and 12 h postdose on Days -1, 7 and 28 (as appropriate);Secondary end point(s): *Change from baseline in mean daily IOP following 7 days of treatment *Change from baseline in mean IOP at each assessment time-points following 7 days of treatment (or 28 days of treatment as appropriate). | — |
Countries
Belgium, Bulgaria, Czech Republic, Hungary, United States
Contacts
Public ContactTrial Information Support Line-TISL
F.Hoffmann-La Roche Ltd.
Outcome results
None listed