Corneal Endothelial Cell Density Changes, When Mapracorat Ophthalmic Suspension 3%, is Administered for 14 Days
This study is ongoing, but not recruiting participants.
Sponsor:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01736462
First received: November 20, 2012
Last updated: May 14, 2013
Last verified: May 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Corneal Endothelial Cell Changes |
Drug: Mapracorat |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label |
| 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 |
Further study details as provided by Bausch & Lomb Incorporated:
Primary Outcome Measures:
- Endothelial Cell Density [ Time Frame: 3 months (Visit 4) ] [ Designated as safety issue: No ]The mean endothelial cell density (cells/mm2)(ECD)
Secondary Outcome Measures:
- Area under the plasma concentration-time curve [ Time Frame: Day 1 (Visit 2) ] [ Designated as safety issue: No ]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 [ Time Frame: Day 15 (Visit 3) ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 60 |
| Study Start Date: | February 2013 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736462
Locations
| United States, New York | |
| 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 |
More Information
No publications provided
| Responsible Party: | Bausch & Lomb Incorporated |
| ClinicalTrials.gov Identifier: | NCT01736462 History of Changes |
| Other Study ID Numbers: | 794 |
| Study First Received: | November 20, 2012 |
| Last Updated: | May 14, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Bausch & Lomb Incorporated:
|
Cornea Endothelial cell density |
ClinicalTrials.gov processed this record on May 16, 2013