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

NCT ID: NCT01736462

Last Updated: 2013-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Corneal Endothelial Cell Changes

Keywords

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Cornea Endothelial cell density

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Mapracorat

Mapracorat ophthalmic suspension, 3%

Group Type EXPERIMENTAL

Mapracorat

Intervention Type DRUG

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

Interventions

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Mapracorat

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Quintus Ngumah, OD, PhD

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

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Bausch & Lomb Inc

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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794

Identifier Type: -

Identifier Source: org_study_id