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Antibiotic

Levofloxacin Ocular Implant for Cataract

Phase 1
Waitlist Available
Led By Michael Coote, MD
Research Sponsored by PolyActiva Pty Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 90
Awards & highlights

Study Summary

This trial will test an investigational eye drop to see if it can improve vision in people scheduled for cataract surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 90 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Levofloxacin concentration in aqueous humor at Day 5 in treated eyes
Safety of the Levofloxacin Ocular Implant
Secondary outcome measures
Number of actuations required to administer the implant

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Levofloxacin Ocular ImplantExperimental Treatment1 Intervention
Biphasic levofloxacin antibiotic implant
Group II: ControlActive Control1 Intervention
Commercially available topical medications as per LEVO-CS102 Surgical Therapy Procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Levofloxacin
FDA approved

Find a Location

Who is running the clinical trial?

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Levofloxacin Ocular Implant been sanctioned by the FDA?

"Because of the limited evidence in its favour, Levofloxacin Ocular Implant received a safety rating of 1 on our scale. This assessment is based upon it being an early-stage Phase 1 trial with only scant data substantiating both efficacy and safety."

Answered by AI

Are volunteers currently being accepted for this medical experiment?

"Per the information posted on clinicaltrials.gov, this experiment is no longer recruiting participants as of September 26th 2022. This trial was first listed on October 23rd and has since been updated; however there are currently 124 other trials actively enrolling patients."

Answered by AI

Who else is applying?

What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study of Levofloxacin Ocular Implant in Patients Undergoing Routine Bilateral Cataract Surgery
2023. "A Study of Levofloxacin Ocular Implant in Patients Undergoing Routine Bilateral Cataract Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05441930.
~0 spots leftby Apr 2025
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