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

May 7, 2010
August 10, 2012
May 2007
October 2007   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01120418 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Corneal Endothelial Cell Density Changes In Healthy Subjects, When Administered ISV-403 for 5 Days
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Healthy
Drug: Besifloxacin Ophthalmic Suspension 0.6%
administered 3 times a day for 5 days to one eye.
Other Name: ISV-403
Experimental: Besifloxacin Ophthalmic Suspension 0.6%
Topical ocular administration three times daily (TID) for 5 days
Intervention: Drug: Besifloxacin Ophthalmic Suspension 0.6%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
February 2008
October 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01120418
507
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Laura Trusso, MS Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP