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

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.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01493271

Enrollment

Registered

2011-12-15

Start date

2011-12-31

Completion date

2012-11-30

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Glaucoma, Open-Angle

Brief summary

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.

Interventions

DRUGPlacebo

Placebo to RO5093151

DRUGRO5093151

oral doses twice daily for up to 28 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment	Day 7

Secondary

Measure	Time frame
Change in mean intraocular pressure (IOP) at each assessment time-points	Up to 28 days
Change in intraocular pressure (IOP) during a placebo lead-in phase	7 days
Change in mean daily intraocular pressure (IOP)	Up to 28 days
Urinary ratio of tetrahydrocortisol to tetrahydrocortisone	7 days
Safety (incidence of adverse events)	Up to 28 days
Pharmacokinetics (area under the concentration time curve)	Day 7

Countries

Bulgaria, Czechia, Hungary, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026