Rochester, New York 14609

  • Corneal Endothelial Cell Changes

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.


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.


NCT ID:

NCT01736462


Primary Contact:

Study Director
Quintus Ngumah, OD, PhD
Bausch & Lomb Incorporated


Backup Contact:

N/A


Location Contact:

Rochester, New York 14609
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 23, 2021

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