Back to resultsA Study of RO5093151 in Patients With Ocular Hypertension Or Open Angle Glaucoma
Primary Purpose
Hypertension, Glaucoma, Open-Angle
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Placebo
RO5093151
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension, Glaucoma, Open-Angle
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Placebo
RO5093151
Arm Description
Outcomes
Primary Outcome Measures
Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment
Secondary Outcome Measures
Change in mean daily intraocular pressure (IOP)
Change in mean intraocular pressure (IOP) at each assessment time-points
Change in intraocular pressure (IOP) during a placebo lead-in phase
Pharmacokinetics (area under the concentration time curve)
Urinary ratio of tetrahydrocortisol to tetrahydrocortisone
Safety (incidence of adverse events)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01493271
Brief Title
A Study of RO5093151 in Patients With Ocular Hypertension Or Open Angle Glaucoma
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
December 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Glaucoma, Open-Angle
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
RO5093151
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to RO5093151
Intervention Type
Drug
Intervention Name(s)
RO5093151
Intervention Description
oral doses twice daily for up to 28 days
Primary Outcome Measure Information:
Title
Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment
Time Frame
Day 7
Secondary Outcome Measure Information:
Title
Change in mean daily intraocular pressure (IOP)
Time Frame
Up to 28 days
Title
Change in mean intraocular pressure (IOP) at each assessment time-points
Time Frame
Up to 28 days
Title
Change in intraocular pressure (IOP) during a placebo lead-in phase
Time Frame
7 days
Title
Pharmacokinetics (area under the concentration time curve)
Time Frame
Day 7
Title
Urinary ratio of tetrahydrocortisol to tetrahydrocortisone
Time Frame
7 days
Title
Safety (incidence of adverse events)
Time Frame
Up to 28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
City
Mt. Pleasant
State/Province
South Carolina
ZIP/Postal Code
29464
Country
United States
City
Sofia
ZIP/Postal Code
1517
Country
Bulgaria
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
City
Litomysi
ZIP/Postal Code
570 14
Country
Czech Republic
City
Praha
ZIP/Postal Code
100 34
Country
Czech Republic
City
Usti Nad Labem
ZIP/Postal Code
401 13
Country
Czech Republic
City
Zlin
ZIP/Postal Code
762 75
Country
Czech Republic
City
Budapest
ZIP/Postal Code
1115
Country
Hungary
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
12. IPD Sharing Statement
Learn more about this trial
A Study of RO5093151 in Patients With Ocular Hypertension Or Open Angle Glaucoma
We'll reach out to this number within 24 hrs