NCT04682288

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2021

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 8, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 23, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

January 4, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2021

Completed
Last Updated

December 8, 2021

Status Verified

December 1, 2021

Enrollment Period

9 months

First QC Date

November 8, 2020

Last Update Submit

December 6, 2021

Conditions

Cataract

Outcome Measures

Primary Outcomes (3)

  • Ocular Inflammation

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

    90 days

  • Endothelial Cell Density

    Change in number of central corneal endothelial cells per mm2

    90 days

  • Intraocular Pressure (IOP)

    Change in IOP measured by Goldmann applenation tonometry

    90 days

Secondary Outcomes (1)

  • Administration procedure

    1 week

Study Arms (1)

Levofloxacin Ocular Implant

EXPERIMENTAL

Biphasic levofloxacin antibiotic implant

Drug: Levofloxacin Ocular Implant

Interventions

Levofloxacin Ocular ImplantDRUG

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

Levofloxacin Ocular Implant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of cataract in the intent to treat eye
  • Endothelial cell density in the study eye of at least 2000 cells per mm2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Ophthalmology Consultants Ltd

St Louis, Missouri, 63131, United States

Location

Carolina Cataract and Laser Centre

Ladson, South Carolina, 29456, United States

Location

Melbourne Eye Specialists

Fitzroy, Victoria, 3065, Australia

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Joseph Gira, MD

    Opthalmology Consultants Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2020

First Posted

December 23, 2020

Study Start

January 4, 2021

Primary Completion

October 14, 2021

Study Completion

October 14, 2021

Last Updated

December 8, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

US(2)AU(1)