Levofloxacin Ocular Implant for Ocular Surgery

• Status: Recruiting
• Trial end date: 2021-12-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PolyActiva Pty Ltd
• Treatments: Levofloxacin; Ofloxacin

Criteria

Inclusion Criteria:

• Diagnosis of cataract in the intent to treat eye

• Endothelial cell density in the study eye of at least 2000 cells per mm2

Exclusion Criteria:

• 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