Levofloxacin Ocular Implant for Cataract

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Melbourne Eye Specialists, Fitzroy, Australia
Cataract
Levofloxacin Ocular Implant - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test an investigational eye drop to see if it can improve vision in people scheduled for cataract surgery. This trial is testing whether Levofloxacin Ocular Implant is effective in treating Cataract. All patients in the trial will receive the treatment, and there is no placebo group. The treatment is free for patients who participate. Levofloxacin Ocular Implant has been previously approved by the FDA for a different condition.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Cataract

Study Objectives

2 Primary · 1 Secondary · Reporting Duration: Day 90

Day 0
Number of actuations required to administer the implant
Day 5
Levofloxacin concentration in aqueous humor at Day 5 in treated eyes
Day 90
Safety of the Levofloxacin Ocular Implant

Trial Safety

Safety Progress

1 of 3

Other trials for Cataract

Trial Design

2 Treatment Groups

Control
1 of 2
Levofloxacin Ocular Implant
1 of 2
Active Control
Experimental Treatment

12 Total Participants · 2 Treatment Groups

Primary Treatment: Levofloxacin Ocular Implant · No Placebo Group · Phase 1

Levofloxacin Ocular Implant
Drug
Experimental Group · 1 Intervention: Levofloxacin Ocular Implant · Intervention Types: Drug
Control
Drug
ActiveComparator Group · 1 Intervention: Control · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levofloxacin Ocular Implant
2021
Completed Phase 1
~10

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 90
Closest Location: Ophthalmology Associates · Saint Louis, MO
Photo of Saint Louis 1Photo of Saint Louis 2Photo of Saint Louis 3
2006First Recorded Clinical Trial
7 TrialsResearching Cataract
48 CompletedClinical Trials

Who is running the clinical trial?

PolyActiva Pty LtdLead Sponsor
4 Previous Clinical Trials
59 Total Patients Enrolled
1 Trials studying Cataract
5 Patients Enrolled for Cataract
Michael Coote, MDPrincipal InvestigatorMelbourne Eye Specialists

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are male or female, and you are 18 years of age or older.
You are willing and able to understand and sign an informed consent form prior to any study-related procedures.
You are scheduled for sequential bilateral cataract surgery by phacoemulsification and posterior chamber IOL implantation.
ECD of greater than or equal to 2000 cells per mm2.
You are fully vaccinated against COVID-19.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.