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A Study of Levofloxacin Ocular Implant in Patients Undergoing Routine Bilateral Cataract Surgery

NCT05441930 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2024-04-12

No results posted yet for this study

Summary

Open label controlled interventional study in eyes in up to 12 subjects (24 eyes) scheduled for uncomplicated bilateral cataract surgery on separate days.

Conditions

  • Cataract

Interventions

DRUG

Levofloxacin 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.

DRUG

Control

Commercially available topical medications as per LEVO-CS102 Surgical Therapy Procedure.

Sponsors & Collaborators

  • PolyActiva Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Michael Coote, MD · Melbourne Eye Specialists

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-23
Primary Completion
2023-12-15
Completion
2024-03-14
FDA Drug
Yes

Countries

  • United States
  • Australia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05441930 on ClinicalTrials.gov