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

NCT ID: NCT01736462

Last Updated: 2013-11-26

Basic Information

• 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

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.

Conditions

Corneal Endothelial Cell Changes

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

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

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

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

Bausch & Lomb Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Quintus Ngumah, OD, PhD

Role: STUDY_DIRECTOR

Bausch & Lomb Incorporated

Locations

Bausch & Lomb Inc

Rochester, New York, United States

Countries

United States

Other Identifiers

794

Identifier Type: -

Identifier Source: org_study_id