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

NCT01736462 | Completed Phase 1

• 1 other identifier: 794
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Keywords

Cornea; Endothelial cell density

Outcome Measures

Primary Outcomes (1)

• Endothelial Cell Density

  The mean endothelial cell density (cells/mm2)(ECD)

  3 months (Visit 4)

Secondary Outcomes (2)

• Area under the plasma concentration-time curve

  Day 1 (Visit 2)

• Area under the plasma concentration-time curve

  Day 15 (Visit 3)

Study Arms (1)

Mapracorat

EXPERIMENTAL

Mapracorat ophthalmic suspension, 3%

Drug: Mapracorat

Interventions

Mapracorat DRUG

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

Mapracorat

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have a Pinhole visual acuity (VA) equal to or better than 20/40 in both eyes.
• Must be in good ocular health

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb Inc

Rochester, New York, 14609, United States

Location

MeSH Terms

Conditions

Corneal Diseases

Interventions

R-1,1,1-trifluoro-4-(5-fluoro-2,3-dihydrobenzofuran-7-yl)-4-methyl-2-(((2-methyl-5-quinolyl)amino)methyl)pentan-2-ol

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Quintus Ngumah, OD, PhD

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2012
• First Posted: November 29, 2012
• Study Start: February 1, 2013
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 26, 2013

Record last verified: 2013-11

Locations

US (1)