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

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.

Condition or disease Intervention/treatment Phase
Hypertension, Glaucoma, Open-Angle Drug: Placebo Drug: RO5093151 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : December 2011
Actual Primary Completion Date : November 2012
Actual Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Placebo to RO5093151

Experimental: RO5093151 Drug: RO5093151
oral doses twice daily for up to 28 days

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

Secondary Outcome Measures :
  1. Change in mean daily intraocular pressure (IOP) [ Time Frame: Up to 28 days ]
  2. Change in mean intraocular pressure (IOP) at each assessment time-points [ Time Frame: Up to 28 days ]
  3. Change in intraocular pressure (IOP) during a placebo lead-in phase [ Time Frame: 7 days ]
  4. Pharmacokinetics (area under the concentration time curve) [ Time Frame: Day 7 ]
  5. Urinary ratio of tetrahydrocortisol to tetrahydrocortisone [ Time Frame: 7 days ]
  6. Safety (incidence of adverse events) [ Time Frame: Up to 28 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01493271

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
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
Budapest, Hungary, 1115
Budapest, Hungary, 1125
Esztergom, Hungary, 2500
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01493271     History of Changes
Other Study ID Numbers: BP25466
First Posted: December 15, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

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