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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01493271

First received: December 14, 2011

Last updated: February 5, 2015

Last verified: February 2015

History of Changes

Tracking Information

First Received Date ^ICMJE

December 14, 2011

Last Updated Date

February 5, 2015

Start Date ^ICMJE

December 2011

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment [ Time Frame: Day 7 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01493271 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in mean daily intraocular pressure (IOP) [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
Change in mean intraocular pressure (IOP) at each assessment time-points [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]
Change in intraocular pressure (IOP) during a placebo lead-in phase [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Pharmacokinetics (area under the concentration time curve) [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
Urinary ratio of tetrahydrocortisol to tetrahydrocortisone [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Safety (incidence of adverse events) [ Time Frame: Up to 28 days ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Hypertension, Ocular, Glaucoma, Open-Angle

Intervention ^ICMJE

Drug: Placebo
Placebo to RO5093151
Drug: RO5093151
oral doses twice daily for up to 28 days

Study Arm (s)

Experimental: 1
Intervention: Drug: RO5093151
Placebo Comparator: 2
Intervention: Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2012

Primary Completion Date

November 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

United States, Bulgaria, Czech Republic, Hungary

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT01493271

Other Study ID Numbers ^ICMJE

BP25466

Has Data Monitoring Committee

Not Provided

Responsible Party

Hoffmann-La Roche

Study Sponsor ^ICMJE

Hoffmann-La Roche

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Clinical Trials

Hoffmann-La Roche

Information Provided By

Hoffmann-La Roche

Verification Date

February 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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