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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01493271
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

December 14, 2011
December 15, 2011
November 2, 2016
December 2011
November 2012   (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 ]
Same as current
Complete list of historical versions of study NCT01493271 on Archive Site
  • Change in mean daily intraocular pressure (IOP) [ Time Frame: Up to 28 days ]
  • Change in mean intraocular pressure (IOP) at each assessment time-points [ Time Frame: Up to 28 days ]
  • Change in intraocular pressure (IOP) during a placebo lead-in phase [ Time Frame: 7 days ]
  • Pharmacokinetics (area under the concentration time curve) [ Time Frame: Day 7 ]
  • Urinary ratio of tetrahydrocortisol to tetrahydrocortisone [ Time Frame: 7 days ]
  • Safety (incidence of adverse events) [ Time Frame: Up to 28 days ]
Same as current
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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
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Hypertension, Glaucoma, Open-Angle
  • Drug: Placebo
    Placebo to RO5093151
  • Drug: RO5093151
    oral doses twice daily for up to 28 days
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: RO5093151
    Intervention: Drug: RO5093151
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
November 2012
November 2012   (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
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Czech Republic,   Hungary,   United States
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

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