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

NCT01120418 | Completed Phase 1

• 1 other identifier: 507
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Keywords

Endothelial cell density; screening

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Endothelial cell density change within treatment group

  Baseline, 5 days

Study Arms (1)

Besifloxacin Ophthalmic Suspension 0.6%

EXPERIMENTAL

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

Drug: Besifloxacin Ophthalmic Suspension 0.6%

Interventions

Besifloxacin Ophthalmic Suspension 0.6% DRUG

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

Also known as: ISV-403

Besifloxacin Ophthalmic Suspension 0.6%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb

Rochester, New York, 14609, United States

Location

Study Officials

• Laura Trusso, MS

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2010
• First Posted: May 11, 2010
• Study Start: May 1, 2007
• Primary Completion: October 1, 2007
• Study Completion: February 1, 2008
• Last Updated: August 13, 2012

Record last verified: 2012-08

Locations

US (1)