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

Phase 1

Withdrawn

• Conditions: Cataract
• Interventions: Drug: Levofloxacin Ocular Implant; Drug: Control

• Registration Number: NCT05441930
• Lead Sponsor: PolyActiva Pty Ltd

Brief Summary

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

Detailed Description

This is a multicenter, open label, controlled, pairwise, interventional study in eyes in up to 12 subjects (24 eyes) scheduled for uncomplicated bilateral cataract surgery on separate days. Eligible individuals provide informed consent; and are screened for inclusion in the study.

Once eligible, subject eyes will be randomized to determine which eye will receive the first surgery. After the first surgery, study participants will receive the control treatment consisting of commercially available topical medications. For the second cataract surgery, study participants will receive a single Levofloxacin Ocular Implant in the posterior sulcus in the surgical eye at the end of cataract surgery. No sham dosing will be conducted in the eyes in the control arm.

Study Timeline

• Study First Submitted: 2022-06-19
• Study First Submitted QC: 2022-06-28
• Study First Posted: 2022-07-01
• Study Start: 2023-06-23
• Primary Completion: 2023-12-15
• Study Completion: 2024-03-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Levofloxacin Ocular Implant	Levofloxacin Ocular Implant	Biphasic levofloxacin antibiotic implant
Control	Control	Commercially available topical medications as per LEVO-CS102 Surgical Therapy Procedure.

Primary Outcome Measures

Name	Time	Method
Safety of the Levofloxacin Ocular Implant	Day 90	Descriptive summary statistics will be used to assess the number and frequency of ocular and non ocular adverse events
Levofloxacin concentration in aqueous humor at Day 5 in treated eyes	Day 5	To determine levofloxacin concentration in aqueous humor at Day 5 in eyes with the Levofloxacin Ocular Implant to facilitate dose adjustment for Phase II studies.

Secondary Outcome Measures

Name	Time	Method
Number of actuations required to administer the implant	Day 0	Clinicians administering the implant will record the number of actuations required to use the custom-built administration device

Trial Locations

Locations (3)

Carolina Cataract and Laser Centre; 🇺🇸 Ladson, South Carolina, United States

Ophthalmology Associates; 🇺🇸 Saint Louis, Missouri, United States

Melbourne Eye Specialists; 🇦🇺 Fitzroy, Victoria, Australia