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

Completed · Phase 1

Conditions studied: Corneal Endothelial Cell Changes

In brief

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.

Key facts

Study ID

NCT01736462

Run by

Bausch & Lomb Incorporated

People needed

61

Starts

2013-02-01

Expected to finish

2013-07-01

Last updated by the study team

2013-11-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Must have a Pinhole visual acuity (VA) equal to or better than 20/40 in both eyes.
• Must be in good ocular health

You may not qualify if…

• Subjects who have known hypersensitivity or contraindication to the study drug or its components.
• Subjects who currently require or are expected to require treatment with any medication listed as a disallowed medication per the Disallowed Therapy section of the protocol.
• Any topical ophthalmic medication, including tear substitutes that cannot be discontinued during the study.
• Subjects who are monocular (fellow eye is absent or fellow eye's Pinhole VA is worse than 20/200).
• Subjects with a history of ocular surgery, or who anticipate ocular surgery in either eye within the study period.
• Presence of significant ocular or systemic disease that the Investigator determines could interfere with the study.

Where it is running

• Bausch & Lomb Inc — Rochester, New York, United States

Full record on ClinicalTrials.gov

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