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

Phase 2

Completed

• Conditions: Hypertension, Glaucoma, Open-Angle
• Interventions: Drug: Placebo; Drug: RO5093151

• Registration Number: NCT01493271
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12
• Study First Submitted: 2011-12-14
• Study First Submitted QC: 2011-12-14
• Study First Posted: 2011-12-15
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Disposition First Submitted: 2016-07-07
• Disposition First Submitted QC: 2016-07-07
• Disposition First Posted: 2016-07-11
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
RO5093151	RO5093151	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (area under the concentration time curve)	Day 7
Change in mean daily intraocular pressure (IOP)	Up to 28 days
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
Urinary ratio of tetrahydrocortisol to tetrahydrocortisone	7 days
Safety (incidence of adverse events)	Up to 28 days