Clinical Trial: A Study of RO5093151 in Patients With Ocular Hypertension Or Open Angle Glaucoma
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 RO50
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.
Detailed Summary:
Sponsor: Hoffmann-La Roche
Current Primary Outcome: Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment [ Time Frame: Day 7 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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 ]
Original Secondary Outcome: Same as current
Information By: Hoffmann-La Roche
Dates:
Date Received: December 14, 2011
Date Started: December 2011
Date Completion:
Last Updated: November 1, 2016
Last Verified: November 2016
