NCT01736462

Corneal Endothelial Cell Density Changes, When Mapracorat Ophthalmic Suspension 3%, is Administered for 14 Days

An Open-Label Study to Evaluate 3 Month Corneal Endothelial Cell Density Changes in Healthy Subjects When Mapracorat Ophthalmic Suspension, 3%, is Administered 4 Times Daily for 14 Days

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Corneal Endothelial Cell Changes

Interventions

Type	Name	Description
DRUG	Mapracorat	One drop of mapracorat ophthalmic suspension, 3% four times daily, at approximately four hour intervals, for 14 days in both eyes.

Timeline

• Start date: 2013-02-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2012-11-29
• Last updated: 2013-11-26

Locations

1 site across 1 country: United States