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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: Besifloxacin Ophthalmic Suspension 0.6%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endothelial cell density, screening