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Completed

NCT Number: NCT01120418

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

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.

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Key information

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Bausch & Lomb

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Besifloxacin Ophthalmic Suspension 0.6%

Drug

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

Other names: ISV-403

Primary outcomes

  1. Endothelial cell density change between treatment group.

    Time frame: 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 outcomes

  1. Endothelial cell density change within treatment group

    Time frame: Baseline, 5 days

    Change from baseline in endothelial cell density within eyes treated with besifloxacin ophthalmic suspension and within untreated fellow eyes.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2008
First posted
May 11, 2010
Registry last updated
Aug 13, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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