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

Bausch + Lomb

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Besifloxacin Ophthalmic Suspension 0.6%

Study type: Interventional

Funder types: Industry

Identifiers

NCT01120418

507

Details and patient eligibility

About

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.

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 1 patient group

Besifloxacin Ophthalmic Suspension 0.6%

Experimental group

Description:

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

Treatment:

Drug: Besifloxacin Ophthalmic Suspension 0.6%