Levofloxacin Ocular Implant for Ocular Surgery

Overview

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.

Full Title of Study: “An Interventional, Open Label, Non-randomized, Phase Ia Safety and Tolerability Study of Levofloxacin Ocular Implant in Subjects Undergoing Routine Cataract Surgery.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 14, 2021

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Levofloxacin Ocular Implant
    • Biphasic levofloxacin antibiotic implant

Clinical Trial Outcome Measures

Primary Measures

  • Ocular Inflammation
    • Time Frame: 90 days
    • Change assessed according to Standardization of Uveitis Nomenclature (SUN) Grading Scale
  • Endothelial Cell Density
    • Time Frame: 90 days
    • Change in number of central corneal endothelial cells per mm2
  • Intraocular Pressure (IOP)
    • Time Frame: 90 days
    • Change in IOP measured by Goldmann applenation tonometry

Secondary Measures

  • Administration procedure
    • Time Frame: 1 week
    • Number of actuation’s required to expel implant

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • PolyActiva Pty Ltd
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joseph Gira, MD, Principal Investigator, Opthalmology Consultants Ltd

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