A Phase 1 interventional study of Mapracorat in Corneal Endothelial Cell Changes, sponsored by Bausch & Lomb Incorporated. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-26.
Sponsored by Bausch & Lomb Incorporated · Phase 1 and Interventional
The objective of this study is to evaluate the effect on corneal endothelial cell density (cells/mm²) changes at 3 months when mapracorat ophthalmic suspension, 3% is administered QID (four times daily), for 14 days in healthy subjects with a normal ophthalmic history.
Bausch & Lomb Incorporated is the lead sponsor of 219 studies on the registry; 7 are open to participants now.
Of its 49 completed or terminated interventional studies of FDA-regulated products, 41 (84%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Mapracorat ophthalmic suspension, 3%
Drug: Mapracorat
One drop of mapracorat ophthalmic suspension, 3% four times daily, at approximately four hour intervals, for 14 days in both eyes.
Endothelial Cell Density
The mean endothelial cell density (cells/mm2)(ECD)
Time frame: 3 months (Visit 4)
Area under the plasma concentration-time curve
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (Ct). Blood samples will be collected for the determination of mapracorat and any potential metabolite(s). Concentrations in plasma measured within 1 hour prior to dosing on day 1 (visit 2).
Time frame: Day 1 (Visit 2)
Area under the plasma concentration-time curve
Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration (Ct). Blood samples will be collected for the determination of mapracorat and any potential metabolite(s). Blood samples will be collected within 1 hour prior to dosing and at 0.25, 0.5, 1, 2, and 4 hours after a single administration of mapracorat at visit 3.
Time frame: Day 15 (Visit 3)
This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.
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Bausch & Lomb Incorporated