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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01120418
First received: May 7, 2010
Last updated: August 10, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Healthy
 Drug: Besifloxacin Ophthalmic Suspension 0.6%
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Endothelial cell density change between treatment group. [ Time Frame: Baseline, 5 days ] [ Designated as safety issue: No ]
    Difference in the change from baseline in endothelial cell density between eyes treated with besifloxacin ophthalmic suspension and untreated fellow eyes.


Secondary Outcome Measures:
  • Endothelial cell density change within treatment group [ Time Frame: Baseline, 5 days ] [ Designated as safety issue: No ]
    Change from baseline in endothelial cell density within eyes treated with besifloxacin ophthalmic suspension and within untreated fellow eyes.


Enrollment: 120
Study Start Date: May 2007
Study Completion Date: February 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: ISV-403

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01120418

Locations
United States, New York
Bausch & Lomb
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Laura Trusso, MS Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01120418     History of Changes
Other Study ID Numbers: 507
Study First Received: May 7, 2010
Last Updated: August 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:
Endothelial cell density
screening

Additional relevant MeSH terms:
Fluoroquinolones
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013