A Study of RO5093151 in Patients With Ocular Hypertension... | NCT01493271

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

NCT01493271

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

31Actual

Phase

Phase 2

Conditions

Hypertension, Glaucoma, Open-Angle

Interventions

Placebo
RO5093151

Countries

United States
Bulgaria
Czechia
Hungary

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

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 Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Dec 14, 2011

First Submission Date that Met QC Criteria

Dec 14, 2011

First Posted Date

Dec 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jul 7, 2016

Certification/Extension First Submitted that Passed QC Review

Jul 7, 2016

Certification/Extension First Posted Date

Jul 11, 2016Estimated

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
RO5093151	Experimental		Drug: RO5093151

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Placebo	Drug	Placebo to RO5093151	Placebo
RO5093151

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Morrow	Georgia	30260	United States

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D005901	Glaucoma

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided