A Phase 2 interventional study of Placebo and RO5093151 in Hypertension, Glaucoma, Open-Angle, sponsored by Hoffmann-La Roche. Completed at 12 sites in 4 countries. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2016-11-02.
Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment
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.
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's enrollment of 31 is below the median of 65 across 1,272 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.
Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Placebo
Drug: RO5093151
Placebo to RO5093151
oral doses twice daily for up to 28 days
Change in mean intraocular pressure (IOP) at 1 hour post-dose following 7 days of treatment
Time frame: Day 7
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
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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Hoffmann-La Roche