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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01120418

Enrollment

120

Registered

2010-05-11

Start date

2007-05-31

Completion date

2008-02-29

Last updated

2012-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Endothelial cell density, screening

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.

Interventions

DRUGBesifloxacin Ophthalmic Suspension 0.6%

administered 3 times a day for 5 days to one eye.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Endothelial cell density change between treatment group.	Baseline, 5 days	Difference in the change from baseline in endothelial cell density between eyes treated with besifloxacin ophthalmic suspension and untreated fellow eyes.

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026