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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Besifloxacin Ophthalmic Suspension 0.6%

• Registration Number: NCT01120418
• Lead Sponsor: Bausch & Lomb Incorporated

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05
• Primary Completion: 2007-10
• Study Completion: 2008-02
• Study First Submitted: 2010-05-07
• Study First Submitted QC: 2010-05-10
• Study First Posted: 2010-05-11
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-10
• Last Update Posted: 2012-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Besifloxacin Ophthalmic Suspension 0.6%	Besifloxacin Ophthalmic Suspension 0.6%	Topical ocular administration three times daily (TID) for 5 days

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Bausch & Lomb; 🇺🇸 Rochester, New York, United States