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

NCT05441930 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: LEVO-CS102
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 3

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.

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

• Safety of the Levofloxacin Ocular Implant

  Descriptive summary statistics will be used to assess the number and frequency of ocular and non ocular adverse events

  Day 90

• Levofloxacin concentration in aqueous humor at Day 5 in treated eyes

  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.

  Day 5

Secondary Outcomes (1)

• Number of actuations required to administer the implant

  Day 0

Study Arms (2)

Levofloxacin Ocular Implant

EXPERIMENTAL

Biphasic levofloxacin antibiotic implant

Drug: Levofloxacin Ocular Implant

Control

ACTIVE COMPARATOR

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

Drug: Control

Interventions

Levofloxacin Ocular Implant DRUG

Levofloxacin Ocular Implant an implant that delivers a bolus dose of levofloxacin and a constant daily dose for a further 5-7 days.

Levofloxacin Ocular Implant

Control DRUG

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female subjects 18 years of age or older.
• Willing and able to understand and sign an informed consent form prior to any study-related procedures.
• Willing and able to follow study instructions, and able to be present for the required study visits/assessments for the duration of the study.
• Diagnosis of cataract in both eyes scheduled for sequential bilateral elective cataract extraction by phacoemulsification and posterior chamber IOL implantation not combined with any other surgery except femtosecond laser.
• Minimum endothelial cell density (ECD) in both eyes of greater than or equal to 2000 cells per mm2.
• Fully vaccinated against COVID-19, as evidenced by vaccination record.

You may not qualify if:

• Ophthalmic:
• Have a history of or current uveitis, macular edema (cystoid or diabetic), diabetic retinopathy, retinal vein occlusion and neovascular glaucoma, corneal conditions such as keratitis, corneal edema or advanced macular degeneration, which in the opinion of the investigator would interfere with study assessments and confound the data.
• In the opinion of the investigator or reading center, have confluent central corneal guttatae, multiple central guttatae greater than a single cell, or corneal disease or abnormality that would prevent specular microscopy corneal scans.
• Aphakia or low vision or monocular.
• Have had any intraocular surgery, glaucoma surgery (including but not limited to filtering surgery like trabeculectomy, Ahmed valve, etc) or cornea/refractive surgery within the past 6 months or anticipate a need for eye surgery (including laser) during the study period.
• Use of prostaglandin (PG) analogues within 60 days prior to Screening or during the course of the study.
• Subjects with clinically diagnosed Fuchs' Endothelial Corneal Dystrophy (FECD)/ history of keratoplasty.
• Subjects for whom an intra-ocular or glaucoma device procedure is planned during the cataract procedure, during study participation or has been previously undertaken.
• Have a current retinal detachment or history of blunt trauma in either eye.
• Subject who in the opinion of the surgeon has a high risk of the posterior capsule being compromised/zonular dehiscence during cataract surgery.
• Intraoperative complications during the cataract surgery including posterior capsule rupture, zonular dehiscence, non-placement of Posterior Chamber Intra Ocular Lens (PCIOL), vitreous prolapse, lens fragments in the vitreous, placement of Anterior Chamber Intra Ocular Lens (ACIOL), uncontrolled bleeding /hyphema.
• Known sensitivity to any component of the product (e.g. fluoroquinolone or polyurethane sensitivity), or to topical therapy used during course of study (e.g., povidone iodine, or anesthetics).
• Used fluoroquinolone antibiotics (topically, orally or systemically) during the 4 weeks before screening visit.

Sponsors & Collaborators

• PolyActiva Pty Ltd: lead

Study Sites (3)

Ophthalmology Associates

St Louis, Missouri, 63131, United States

Location

Carolina Cataract and Laser Centre

Ladson, South Carolina, 29456, United States

Location

Melbourne Eye Specialists

Fitzroy, Victoria, 3065, Australia

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Michael Coote, MD

  Melbourne Eye Specialists

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: June 19, 2022
• First Posted: July 1, 2022
• Study Start: June 23, 2023
• Primary Completion: December 15, 2023
• Study Completion: March 14, 2024
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); AU (1)