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

Phase 1

Completed

• Conditions: Corneal Endothelial Cell Changes
• Interventions: Drug: Mapracorat

• Registration Number: NCT01736462
• Lead Sponsor: Bausch & Lomb Incorporated

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-11-20
• Study First Submitted QC: 2012-11-26
• Study First Posted: 2012-11-29
• Study Start: 2013-02
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-22
• Last Update Posted: 2013-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mapracorat	Mapracorat	Mapracorat ophthalmic suspension, 3%

Primary Outcome Measures

Name	Time	Method
Endothelial Cell Density	3 months (Visit 4)	The mean endothelial cell density (cells/mm2)(ECD)

Secondary Outcome Measures

Name	Time	Method
Area under the plasma concentration-time curve	Day 15 (Visit 3)	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.

Trial Locations

Locations (1)

Bausch & Lomb Inc; 🇺🇸 Rochester, New York, United States