NCT01120418

CompletedPhase 1

Corneal Endothelial Cell Density Changes In Healthy Subjects...

Bausch & Lomb Incorporated Source

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

507

Study Type

interventional

Actual enrollment (reported)

120

Locations

1 country

Sites

1

Timeline

Study Start

May 2007

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

October 2007

Actual (reported)

Study Completion

February 2008

Actual (reported)

Brief Summary

The objective of this study is to evaluate the effect on corneal endothelial cell density changes when ISV-403 is administered for five (5) days compared to no drug treatment, in healthy subjects.

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): 120 participants
Study completion date: February 2008
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

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

Study Start
May 2007
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
October 2007
Actual (reported)
Study Completion
February 2008
Actual (reported)
First Submitted
May 7, 2010
Actual (reported)
First Posted
May 11, 2010
Actual (reported)

Last Updated: August 13, 2012
Status Verified: August 2012
Last Update Submitted: August 10, 2012

Conditions

Healthy

Keywords

Endothelial cell densityscreening

Outcome Measures

Primary Outcomes (1)

Endothelial cell density change between treatment group.
Difference in the change from baseline in endothelial cell density between eyes treated with besifloxacin ophthalmic suspension and untreated fellow eyes.
Baseline, 5 days

Secondary Outcomes (1)

Endothelial cell density change within treatment group
Baseline, 5 days

Study Arms (1)

Besifloxacin Ophthalmic Suspension 0.6%

EXPERIMENTAL

Topical ocular administration three times daily (TID) for 5 days

Drug: Besifloxacin Ophthalmic Suspension 0.6%

Interventions

Besifloxacin Ophthalmic Suspension 0.6%Drug

administered 3 times a day for 5 days to one eye.

Also known as: ISV-403

Besifloxacin Ophthalmic Suspension 0.6%

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Must have pin-holed Snellen visual acuity equal to or better than 20/40, in both eyes
Must be in good health (no current or past relevant medical/ocular history) based on the judgment of the Investigator

Sponsors & Collaborators

Bausch & Lomb Incorporated
Industrylead

Study Sites (1)

Bausch & Lomb

Rochester, New York, 14609, United States

Study Officials

Laura Trusso, MS
Bausch & Lomb Incorporated
STUDY DIRECTOR

Enrollment

120 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: NONE
Purpose: SCREENING
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 7, 2010

First Posted

May 11, 2010

Study Start

May 2007

Date type not reported

This date has not been verified as actual or estimated.

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Must be willing to discontinue contact lens wear for the duration of the study

You may not qualify if:

Known hypersensitivity to fourth generation fluoroquinolone (SS734) or to any of the ingredients in the study medication Investigator determines could interfere with the study
History of extended or continuous wear contact lens use other than silicone hydrogels
History of intraocular surgery
Any topical ophthalmic medication, including tear substitutes, that cannot be discontinued during the study
Participation in an ophthalmic drug or device research study within the 30 days prior to entry in this study

Contact the study team to confirm eligibility.

Primary Completion

October 2007

Actual (reported)

Study Completion

February 2008

Actual (reported)

Last Updated

August 13, 2012

Record last verified: 2012-08

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: NCT01120418
Data provider: ClinicalTrials.gov
Source updated: 2012-08-13
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:14 UTC

Locations

US(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Primary Completion

Study Completion

First Submitted

First Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

Besifloxacin Ophthalmic Suspension 0.6%

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations