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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01736462
First received: November 20, 2012
Last updated: November 22, 2013
Last verified: November 2013
  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.


Enrollment: 61
Study Start Date: February 2013
Study Completion Date: July 2013
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: November 22, 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 April 17, 2014