Levofloxacin Ocular Implant for Ocular Surgery

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04682288

Enrollment

Registered

2020-12-23

Start date

2021-01-04

Completion date

2021-10-14

Last updated

2021-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

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.

Interventions

DRUGLevofloxacin 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Australia, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026