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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01736462

Enrollment

Registered

2012-11-29

Start date

2013-02-28

Completion date

2013-07-31

Last updated

2013-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal Endothelial Cell Changes

Keywords

Cornea, Endothelial cell density

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.

Interventions

DRUGMapracorat

One drop of mapracorat ophthalmic suspension, 3% four times daily, at approximately four hour intervals, for 14 days in both eyes.

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Endothelial Cell Density	3 months (Visit 4)	The mean endothelial cell density (cells/mm2)(ECD)

Secondary

Measure	Time frame	Description
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).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026