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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
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 5 Other Conditions

Summary

This trial involves patients who are having cataract surgery on both eyes. One eye will receive standard eye drops, while the other will get a small device that releases an antibiotic directly into the eye. The goal is to see if the implant can better prevent infections compared to regular eye drops.

Eligible Conditions
  • Cataract
  • Pseudoaphakia

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

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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.

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
~0 spots leftby Nov 2025
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