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Completed

NCT Number: NCT04682288

Levofloxacin Ocular Implant for Ocular Surgery

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.

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Melbourne Eye Specialists, Fitzroy, Victoria, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levofloxacin Ocular Implant

Drug

Levofloxacin Ocular Implant an implant that delivers a bolus dose of levofloxacin and a constant daily dose for a further 5-7 days.

Primary outcomes

  1. Ocular Inflammation

    Time frame: 90 days

    Change assessed according to Standardization of Uveitis Nomenclature (SUN) Grading Scale

  2. Endothelial Cell Density

    Time frame: 90 days

    Change in number of central corneal endothelial cells per mm2

  3. Intraocular Pressure (IOP)

    Time frame: 90 days

    Change in IOP measured by Goldmann applenation tonometry

Secondary outcomes

  1. Administration procedure

    Time frame: 1 week

    Number of actuation's required to expel implant

Sponsors and collaborators

Lead sponsor

PolyActiva Pty Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 23, 2020
Registry last updated
Dec 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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