Levofloxacin Ocular Implant for Ocular Surgery

PolyActiva

Status and phase: Completed; Phase 1

Conditions: Cataract

Treatments: Drug: Levofloxacin Ocular Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT04682288

LEVO-CS101

Details and patient eligibility

About

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.

Enrollment: 5 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Levofloxacin Ocular Implant

Experimental group

Description:

Biphasic levofloxacin antibiotic implant

Treatment:

Drug: Levofloxacin Ocular Implant