NCT01736462

CompletedPhase 1

Corneal Endothelial Cell Density Changes, When Mapracorat Op...

Bausch & Lomb Incorporated Source

ClinicalTrials.gov

Compare

Other study identifiers

Sponsor study identifier

794

Study Type

interventional

Actual enrollment (reported)

61

Locations

1 country

Sites

1

Timeline

Study Start

February 2013

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

July 2013

Actual (reported)

Study Completion

July 2013

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 61 participants
Study completion date: July 2013
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
November 20, 2012
Actual (reported)
First Posted
November 29, 2012
Actual (reported)
Study Start
February 2013
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
July 2013
Actual (reported)
Study Completion
July 2013
Actual (reported)

Last Updated: November 26, 2013
Status Verified: November 2013
Last Update Submitted: November 22, 2013

Conditions

Corneal Endothelial Cell Changes

Keywords

CorneaEndothelial 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

MapracoratDrug

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

Mapracorat

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (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:

Sponsors & Collaborators

Bausch & Lomb Incorporated
Industrylead

Study Sites (1)

Bausch & Lomb Inc

Rochester, New York, 14609, United States

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

Enrollment

61 participants (actual enrollment reported by the registry).

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 2013

Date type not reported

This date has not been verified as actual or estimated.

NCT01408511

HPA Axis Study in Adults

Phase 2Completed

NCT01407510

HPA Axis Study in Japanese Adults

Phase 2Completed

NCT01289431

Mapracorat Ophthalmic Formulation in Subjects With Allergic Conjunctivitis

Phase 2Completed

NCT00905450

Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery

Phase 2Completed

NCT01359787

Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)

Phase 2Completed

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.

Contact the study team to confirm eligibility.

Primary Completion

July 2013

Actual (reported)

Study Completion

July 2013

Actual (reported)

Last Updated

November 26, 2013

Record last verified: 2013-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01736462
Data provider: ClinicalTrials.gov
Source updated: 2013-11-26
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:35:02 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Mapracorat

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations