A Study of RO5093151 in Patients With Ocular Hypertension Or Open Angle Glaucoma

Status:	Completed
Conditions:	High Blood Pressure (Hypertension), Ocular
Therapuetic Areas:	Cardiology / Vascular Diseases, Ophthalmology
Healthy:	No
Age Range:	21 - Any
Updated:	8/3/2016
Start Date:	December 2011
End Date:	November 2012

An Adaptive, Multi-center, Randomized, Investigator-masked, Subject-masked, Multiple-dose, Placebo-controlled, Parallel Study to Investigate Efficacy, Safety, Tolerability and Pharmacokinetics of RO5093151 for up to 28 Days in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension.

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.

Inclusion Criteria:

- Adult patients, at least 21 years of age, inclusive

- Diagnosis of ocular hypertension or primary open angle glaucoma in at least one eye

- Able to participate and willing to give informed consent

Exclusion Criteria:

- Presence of extreme narrow angle with complete or partial closure

- Progressive retinal or optic nerve disease from any cause other than glaucoma

- History or signs of penetrating ocular trauma

- Uncontrolled hypertension

- Clinically significant abnormalities in laboratory test results

- Positive test results on hepatitis B, hepatitis C, or HIV 1 and 2

- Kidney disease or dysfunction

We found this trial at

sites

Clinical Trial Facility in High Point North Carolina

High Point, North Carolina

from

High Point, NC