Corneal Endothelial Cell Density Changes In Healthy Subjects, When Administered ISV-403 for 5 Days

August 10, 2012 updated by: Bausch & Lomb Incorporated

A Randomized, Contralateral Study To Evaluate Corneal Endothelial Cell Density Changes In Healthy Subjects, When Administered 0.6% ISV-403 Three Times Daily For Five Days

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Rochester, New York, United States, 14609
        • Bausch & Lomb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Besifloxacin Ophthalmic Suspension 0.6%
Topical ocular administration three times daily (TID) for 5 days
Drug: Besifloxacin Ophthalmic Suspension 0.6%
administered 3 times a day for 5 days to one eye.
Other Names:
  • ISV-403

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial cell density change between treatment group.
Time Frame: Baseline, 5 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial cell density change within treatment group
Time Frame: Baseline, 5 days
Change from baseline in endothelial cell density within eyes treated with besifloxacin ophthalmic suspension and within untreated fellow eyes.
Baseline, 5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Investigators

  • Study Director: Laura Trusso, MS, Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

February 1, 2008

Study Registration Dates

First Submitted

May 7, 2010

First Submitted That Met QC Criteria

May 10, 2010

First Posted (Estimate)

May 11, 2010

Study Record Updates

Last Update Posted (Estimate)

August 13, 2012

Last Update Submitted That Met QC Criteria

August 10, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 507 (Tehran University of Medical Sciences)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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