Corneal Endothelial Cell Density Changes, When Mapracorat Ophthalmic Suspension 3%, is Administered for 14 Days
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mapracorat Mapracorat ophthalmic suspension, 3% |
Drug: Mapracorat
One drop of mapracorat ophthalmic suspension, 3% four times daily, at approximately four hour intervals, for 14 days in both eyes.
|
Outcome Measures
Primary Outcome Measures
- Endothelial Cell Density [3 months (Visit 4)]
The mean endothelial cell density (cells/mm2)(ECD)
Secondary Outcome Measures
- Area under the plasma concentration-time curve [Day 1 (Visit 2)]
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).
- 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.
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Bausch & Lomb Inc | Rochester | New York | United States | 14609 |
Sponsors and Collaborators
- Bausch & Lomb Incorporated
Investigators
- Study Director: Quintus Ngumah, OD, PhD, Bausch & Lomb Incorporated
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 794