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

Sponsor
Bausch & Lomb Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT01120418
Collaborator
(none)
120
Enrollment
1
Location
1
Arm
9.1
Duration (Months)
13.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Besifloxacin Ophthalmic Suspension 0.6%
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
120 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
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
Study Start Date :
May 1, 2007
Actual Primary Completion Date :
Oct 1, 2007
Actual Study Completion Date :
Feb 1, 2008

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Endothelial cell density change between treatment group. [Baseline, 5 days]

      Difference in the change from baseline in endothelial cell density between eyes treated with besifloxacin ophthalmic suspension and untreated fellow eyes.

    Secondary Outcome Measures

    1. Endothelial cell density change within treatment group [Baseline, 5 days]

      Change from baseline in endothelial cell density within eyes treated with besifloxacin ophthalmic suspension and within untreated fellow eyes.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bausch & Lomb Rochester New York United States 14609

    Sponsors and Collaborators

    • Bausch & Lomb Incorporated

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bausch & Lomb Incorporated
    ClinicalTrials.gov Identifier:
    NCT01120418
    Other Study ID Numbers:
    • 507
    First Posted:
    May 11, 2010
    Last Update Posted:
    Aug 13, 2012
    Last Verified:
    Aug 1, 2012
    Keywords provided by Bausch & Lomb Incorporated
    Endothelial cell density
    screening
    Additional relevant MeSH terms:
    Besifloxacin

    Study Results

    No Results Posted as of Aug 13, 2012