Levofloxacin Ocular Implant for Ocular Surgery
Study Details
Study Description
Brief Summary
This is a multi center, open label, interventional study in one eye of 5 subjects scheduled for uncomplicated cataract surgery with administration of a single Levofloxacin Ocular Implant in the posterior sulcus of the surgical eye at the end of cataract surgery.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Levofloxacin Ocular Implant Biphasic levofloxacin antibiotic implant |
Drug: 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.
|
Outcome Measures
Primary Outcome Measures
- Ocular Inflammation [90 days]
Change assessed according to Standardization of Uveitis Nomenclature (SUN) Grading Scale
- Endothelial Cell Density [90 days]
Change in number of central corneal endothelial cells per mm2
- Intraocular Pressure (IOP) [90 days]
Change in IOP measured by Goldmann applenation tonometry
Secondary Outcome Measures
- Administration procedure [1 week]
Number of actuation's required to expel implant
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of cataract in the intent to treat eye
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Endothelial cell density in the study eye of at least 2000 cells per mm2
Exclusion Criteria:
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history of ocular inflammation including, macular degeneration, uveitis, macular edema or corneal edema
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recent surgery in the study eye
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subjects receiving a glaucoma device in conjunction with cataract surgery
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subjects with a compromised posterior capsule during surgery
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corneal disease that prevents effective imaging of endothelium including Fuch's Dystrophy.
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sensitivity to fluoroquinolones
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Ophthalmology Consultants Ltd | Saint Louis | Missouri | United States | 63131 |
2 | Carolina Cataract and Laser Centre | Ladson | South Carolina | United States | 29456 |
3 | Melbourne Eye Specialists | Fitzroy | Victoria | Australia | 3065 |
Sponsors and Collaborators
- PolyActiva Pty Ltd
Investigators
- Principal Investigator: Joseph Gira, MD, Opthalmology Consultants Ltd
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- LEVO-CS101