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

November 1, 2016 updated by: Hoffmann-La Roche

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1517
  • Czech Republic
      • Hradec Kralove, Czech Republic, 500 05
      • Litomysi, Czech Republic, 570 14
      • Praha, Czech Republic, 100 34
      • Usti Nad Labem, Czech Republic, 401 13
      • Zlin, Czech Republic, 762 75
  • Hungary
      • Budapest, Hungary, 1115
      • Budapest, Hungary, 1125
      • Esztergom, Hungary, 2500
  • United States
    • Georgia
      • Morrow, Georgia, United States, 30260
    • North Carolina
      • High Point, North Carolina, United States, 27262
    • South Carolina
      • Mt. Pleasant, South Carolina, United States, 29464

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo to RO5093151
Experimental: RO5093151
Drug: RO5093151
oral doses twice daily for up to 28 days

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in mean daily intraocular pressure (IOP)
Time Frame: Up to 28 days
Up to 28 days
Change in mean intraocular pressure (IOP) at each assessment time-points
Time Frame: Up to 28 days
Up to 28 days
Change in intraocular pressure (IOP) during a placebo lead-in phase
Time Frame: 7 days
7 days
Pharmacokinetics (area under the concentration time curve)
Time Frame: Day 7
Day 7
Urinary ratio of tetrahydrocortisol to tetrahydrocortisone
Time Frame: 7 days
7 days
Safety (incidence of adverse events)
Time Frame: Up to 28 days
Up to 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

December 14, 2011

First Submitted That Met QC Criteria

December 14, 2011

First Posted (Estimate)

December 15, 2011

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BP25466

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension, Glaucoma, Open-Angle

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ethiopia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe