Levofloxacin Ocular Implant for Ocular Surgery

Completed · Phase 1

Conditions studied: Cataract

In brief

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.

Key facts

Study ID

NCT04682288

Run by

PolyActiva Pty Ltd

People needed

5

Starts

2021-01-04

Expected to finish

2021-10-14

Last updated by the study team

2021-12-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of cataract in the intent to treat eye
• Endothelial cell density in the study eye of at least 2000 cells per mm2

You may not qualify if…

• 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

Where it is running

• Ophthalmology Consultants Ltd — St Louis, Missouri, United States
• Carolina Cataract and Laser Centre — Ladson, South Carolina, United States
• Melbourne Eye Specialists — Fitzroy, Victoria, Australia

Full record on ClinicalTrials.gov

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