Levofloxacin Ocular Implant for Ocular Surgery

December 6, 2021 updated by: PolyActiva Pty Ltd

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Melbourne Eye Specialists
  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63131
        • Ophthalmology Consultants Ltd
    • South Carolina
      • Ladson, South Carolina, United States, 29456
        • Carolina Cataract and Laser Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levofloxacin Ocular Implant
Biphasic levofloxacin antibiotic implant
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Administration procedure
Time Frame: 1 week
Number of actuation's required to expel implant
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PolyActiva Pty Ltd

Investigators

  • Principal Investigator: Joseph Gira, MD, Opthalmology Consultants Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 4, 2021

Primary Completion (Actual)

October 14, 2021

Study Completion (Actual)

October 14, 2021

Study Registration Dates

First Submitted

November 8, 2020

First Submitted That Met QC Criteria

December 20, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

December 8, 2021

Last Update Submitted That Met QC Criteria

December 6, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEVO-CS101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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