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

Bausch & Lomb Incorporated1 site in 1 country120 target enrollmentMay 2007

ConditionsHealthy

InterventionsBesifloxacin Ophthalmic Suspension 0.6%

DrugsBesifloxacin Ophthalmic Suspension 0.6%

Overview

Phase: Phase 1
Intervention: Besifloxacin Ophthalmic Suspension 0.6%
Conditions: Healthy
Sponsor: Bausch & Lomb Incorporated
Enrollment: 120
Locations: 1
Primary Endpoint: Endothelial cell density change between treatment group.
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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

clinicaltrials.gov

Start Date

May 2007

End Date

February 2008

Last Updated

13 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Bausch & Lomb Incorporated

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Besifloxacin Ophthalmic Suspension 0.6%

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

Intervention: Besifloxacin Ophthalmic Suspension 0.6%

Outcomes

Primary Outcomes

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.