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: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Hypertension, Ocular, Glaucoma, Open-Angle
Drug: RO5093151
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 31
Study Start Date: December 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: RO5093151
oral doses twice daily for up to 28 days
Placebo Comparator: 2 Drug: Placebo
Placebo to RO5093151

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01493271

Locations
United States, Georgia
Morrow, Georgia, United States, 30260
United States, North Carolina
High Point, North Carolina, United States, 27262
United States, South Carolina
Mt. Pleasant, South Carolina, United States, 29464
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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01493271     History of Changes
Other Study ID Numbers: BP25466
Study First Received: December 14, 2011
Last Updated: March 3, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 17, 2014