Text Size

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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01493271
First received: December 14, 2011
Last updated: April 1, 2013
Last verified: April 2013
History of Changes

December 14, 2011
April 1, 2013
December 2011
April 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01493271 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study of RO5093151 in Patients With Ocular Hypertension Or Open Angle Glaucoma
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension, Ocular, Glaucoma, Open-Angle
  • Drug: RO5093151
    oral doses twice daily for up to 28 days
  • Drug: Placebo
    Placebo to RO5093151
  • Experimental: 1
    Intervention: Drug: RO5093151
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
31
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Czech Republic,   Hungary
 
NCT01493271
BP25466
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP