Corneal Endothelial Cell Density Changes In Healthy Subjects, When Administered ISV-403 for 5 Days
NCT ID: NCT01120418
Last Updated: 2012-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
120 participants
INTERVENTIONAL
2007-05-31
2008-02-29
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Besifloxacin Ophthalmic Suspension 0.6%
Topical ocular administration three times daily (TID) for 5 days
Besifloxacin Ophthalmic Suspension 0.6%
administered 3 times a day for 5 days to one eye.
Interventions
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Besifloxacin Ophthalmic Suspension 0.6%
administered 3 times a day for 5 days to one eye.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Bausch & Lomb Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Laura Trusso, MS
Role: STUDY_DIRECTOR
Bausch & Lomb Incorporated
Locations
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Bausch & Lomb
Rochester, New York, United States
Countries
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Other Identifiers
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507
Identifier Type: -
Identifier Source: org_study_id