Status:
COMPLETED
Levofloxacin Ocular Implant for Ocular Surgery
Lead Sponsor:
PolyActiva Pty Ltd
Conditions:
Cataract
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 poster...
Eligibility Criteria
Inclusion
- Diagnosis of cataract in the intent to treat eye
- Endothelial cell density in the study eye of at least 2000 cells per mm2
Exclusion
- history of ocular inflammation including, macular degeneration, uveitis, macular edema or corneal edema
- 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
Key Trial Info
Start Date :
January 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 14 2021
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04682288
Start Date
January 4 2021
End Date
October 14 2021
Last Update
December 8 2021
Active Locations (3)
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1
Ophthalmology Consultants Ltd
St 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