Levofloxacin Ocular Implant for Ocular Surgery

Sponsor
PolyActiva Pty Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT04682288
Collaborator
(none)
5
3
1
9.3
1.7
0.2

Study Details

Study Description

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
  • Drug: Levofloxacin Ocular Implant
Phase 1

Study Design

Study Type:
Interventional
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 :
Jan 4, 2021
Actual Primary Completion Date :
Oct 14, 2021
Actual Study Completion Date :
Oct 14, 2021

Arms and Interventions

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

Primary Outcome Measures

  1. Ocular Inflammation [90 days]

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

  2. Endothelial Cell Density [90 days]

    Change in number of central corneal endothelial cells per mm2

  3. Intraocular Pressure (IOP) [90 days]

    Change in IOP measured by Goldmann applenation tonometry

Secondary Outcome Measures

  1. Administration procedure [1 week]

    Number of actuation's required to expel implant

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Ophthalmology Consultants Ltd Saint Louis Missouri United States 63131
2 Carolina Cataract and Laser Centre Ladson South Carolina United States 29456
3 Melbourne Eye Specialists Fitzroy Victoria Australia 3065

Sponsors and Collaborators

  • PolyActiva Pty Ltd

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
PolyActiva Pty Ltd
ClinicalTrials.gov Identifier:
NCT04682288
Other Study ID Numbers:
  • LEVO-CS101
First Posted:
Dec 23, 2020
Last Update Posted:
Dec 8, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 8, 2021