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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Completed
CT.gov ID
NCT01493271
Collaborator
(none)
31
Enrollment
12
Locations
2
Arms
11
Duration (Months)
2.6
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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
Phase 2

Study Design

Study Type:
Interventional
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 :
Dec 1, 2011
Actual Primary Completion Date :
Nov 1, 2012
Actual Study Completion Date :
Nov 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Drug: Placebo
Placebo to RO5093151
Experimental: RO5093151

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

Outcome Measures

Primary Outcome Measures

  1. Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment [Day 7]

Secondary Outcome Measures

  1. Change in mean daily intraocular pressure (IOP) [Up to 28 days]

  2. Change in mean intraocular pressure (IOP) at each assessment time-points [Up to 28 days]

  3. Change in intraocular pressure (IOP) during a placebo lead-in phase [7 days]

  4. Pharmacokinetics (area under the concentration time curve) [Day 7]

  5. Urinary ratio of tetrahydrocortisol to tetrahydrocortisone [7 days]

  6. Safety (incidence of adverse events) [Up to 28 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Morrow Georgia United States 30260
2 High Point North Carolina United States 27262
3 Mt. Pleasant South Carolina United States 29464
4 Sofia Bulgaria 1517
5 Hradec Kralove Czech Republic 500 05
6 Litomysi Czech Republic 570 14
7 Praha Czech Republic 100 34
8 Usti Nad Labem Czech Republic 401 13
9 Zlin Czech Republic 762 75
10 Budapest Hungary 1115
11 Budapest Hungary 1125
12 Esztergom Hungary 2500

Sponsors and Collaborators

  • Hoffmann-La Roche

Investigators

  • Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01493271
Other Study ID Numbers:
  • BP25466
First Posted:
Dec 15, 2011
Last Update Posted:
Nov 2, 2016
Last Verified:
Nov 1, 2016
Additional relevant MeSH terms:
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension

Study Results

No Results Posted as of Nov 2, 2016