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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 20, 2014