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
5 participants
INTERVENTIONAL
2021-01-04
2021-10-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Levofloxacin Ocular Implant
Biphasic levofloxacin antibiotic implant
Levofloxacin Ocular Implant
Levofloxacin Ocular Implant an implant that delivers a bolus dose of levofloxacin and a constant daily dose for a further 5-7 days.
Interventions
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Levofloxacin Ocular Implant
Levofloxacin Ocular Implant an implant that delivers a bolus dose of levofloxacin and a constant daily dose for a further 5-7 days.
Eligibility Criteria
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Inclusion Criteria
* Endothelial cell density in the study eye of at least 2000 cells per mm2
Exclusion Criteria
* recent surgery in the study eye
* subjects receiving a glaucoma device in conjunction with cataract surgery
* subjects with a compromised posterior capsule during surgery
* corneal disease that prevents effective imaging of endothelium including Fuch's Dystrophy.
* sensitivity to fluoroquinolones
18 Years
ALL
No
Sponsors
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PolyActiva Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Joseph Gira, MD
Role: PRINCIPAL_INVESTIGATOR
Opthalmology Consultants Ltd
Locations
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Ophthalmology Consultants Ltd
St Louis, Missouri, United States
Carolina Cataract and Laser Centre
Ladson, South Carolina, United States
Melbourne Eye Specialists
Fitzroy, Victoria, Australia
Countries
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Other Identifiers
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LEVO-CS101
Identifier Type: -
Identifier Source: org_study_id