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

Bausch & Lomb Incorporated1 site in 1 country61 target enrollmentFebruary 2013

ConditionsCorneal Endothelial Cell Changes

InterventionsMapracorat

DrugsMapracorat

Overview

Phase: Phase 1
Intervention: Mapracorat
Conditions: Corneal Endothelial Cell Changes
Sponsor: Bausch & Lomb Incorporated
Enrollment: 61
Locations: 1
Primary Endpoint: Endothelial Cell Density
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2013

End Date

July 2013

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Bausch & Lomb Incorporated

Responsible Party

Sponsor

Eligibility Criteria

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.