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

Study 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.

Official Title
-----------------
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

Conditions
-----------------
Corneal Endothelial Cell Changes

Intervention / Treatment
-----------------
* Drug: Mapracorat


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mapracorat<br>Mapracorat ophthalmic suspension, 3% | Drug: Mapracorat<br>* One drop of mapracorat ophthalmic suspension, 3% four times daily, at approximately four hour intervals, for 14 days in both eyes.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Cell Density | The mean endothelial cell density (cells/mm2)(ECD) | 3 months (Visit 4) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | Day 15 (Visit 3) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cornea, Endothelial cell density