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Levofloxacin Ocular Implant for Ocular Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04682288
Recruitment Status : Completed
First Posted : December 23, 2020
Last Update Posted : December 8, 2021
Sponsor:
Information provided by (Responsible Party):
PolyActiva Pty Ltd

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cataract Drug: Levofloxacin Ocular Implant Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Interventional, Open Label, Non-randomized, Phase Ia Safety and Tolerability Study of Levofloxacin Ocular Implant in Subjects Undergoing Routine Cataract Surgery.
Actual Study Start Date : January 4, 2021
Actual Primary Completion Date : October 14, 2021
Actual Study Completion Date : October 14, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  1. Administration procedure [ Time Frame: 1 week ]
    Number of actuation's required to expel implant


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04682288


Locations
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United States, Missouri
Ophthalmology Consultants Ltd
Saint Louis, Missouri, United States, 63131
United States, South Carolina
Carolina Cataract and Laser Centre
Ladson, South Carolina, United States, 29456
Australia, Victoria
Melbourne Eye Specialists
Fitzroy, Victoria, Australia, 3065
Sponsors and Collaborators
PolyActiva Pty Ltd
Investigators
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Principal Investigator: Joseph Gira, MD Opthalmology Consultants Ltd
More Information
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Responsible Party: PolyActiva Pty Ltd
ClinicalTrials.gov Identifier: NCT04682288    
Other Study ID Numbers: LEVO-CS101
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: December 8, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Levofloxacin
Ofloxacin
Anti-Infective Agents, Urinary
Anti-Infective Agents
Renal Agents
 Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors