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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mapracorat | Experimental | Mapracorat ophthalmic suspension, 3% |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mapracorat | Drug | One drop of mapracorat ophthalmic suspension, 3% four times daily, at approximately four hour intervals, for 14 days in both eyes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial Cell Density | The mean endothelial cell density (cells/mm2)(ECD) | 3 months (Visit 4) |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quintus Ngumah, OD, PhD | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Inc | Rochester | New York | 14609 | United States |
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| ID | Term |
|---|---|
| D003316 | Corneal Diseases |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C546413 | R-1,1,1-trifluoro-4-(5-fluoro-2,3-dihydrobenzofuran-7-yl)-4-methyl-2-(((2-methyl-5-quinolyl)amino)methyl)pentan-2-ol |
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| 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) |