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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01120418

Run by

Bausch & Lomb Incorporated

People needed

120

Starts

2007-05-01

Expected to finish

2008-02-01

Last updated by the study team

2012-08-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Bausch & Lomb — Rochester, New York, United States

Full record on ClinicalTrials.gov

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