A study investigating if RO5093151 is better than no treatment and if it causes side effects in patients who have glaucoma or high pressure in the eye.

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

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

* 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): Change from baseline in mean daily IOP following 7 days of treatment<br>Change from baseline in mean IOP at each assessment time-points following 7 days of treatment (or 28 days of treatment as appropriate).<br>;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)

Related Trials