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

Tracking Information
First Submitted Date ICMJE	December 14, 2011
First Posted Date ICMJE	December 15, 2011
Last Update Posted Date	November 2, 2016
Study Start Date ICMJE	December 2011
Actual Primary Completion Date	November 2012 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: December 14, 2011)	Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment [ Time Frame: Day 7 ]
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; (submitted: December 14, 2011)	Change in mean daily intraocular pressure (IOP) [ Time Frame: Up to 28 days ]; Change in mean intraocular pressure (IOP) at each assessment time-points [ Time Frame: Up to 28 days ]; Change in intraocular pressure (IOP) during a placebo lead-in phase [ Time Frame: 7 days ]; Pharmacokinetics (area under the concentration time curve) [ Time Frame: Day 7 ]; Urinary ratio of tetrahydrocortisol to tetrahydrocortisone [ Time Frame: 7 days ]; Safety (incidence of adverse events) [ Time Frame: Up to 28 days ]
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; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
Condition ICMJE	Hypertension, Glaucoma, Open-Angle
Intervention ICMJE	Drug: Placebo Placebo to RO5093151; Drug: RO5093151 oral doses twice daily for up to 28 days
Study Arms	Placebo Comparator: Placebo Intervention: Drug: Placebo; Experimental: RO5093151 Intervention: Drug: RO5093151
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
Actual Enrollment ICMJE; (submitted: January 3, 2013)	31
Original Estimated Enrollment ICMJE; (submitted: December 14, 2011)	60
Actual Study Completion Date	November 2012
Actual 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
Sex/Gender	Sexes Eligible for Study: All
Ages	21 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Bulgaria, Czech Republic, Hungary, United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT01493271
Other Study ID Numbers ICMJE	BP25466
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	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
PRS Account	Hoffmann-La Roche
Verification Date	November 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP