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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05441930




Registration number
NCT05441930
Ethics application status
Date submitted
19/06/2022
Date registered
1/07/2022

Titles & IDs
Public title
A Study of Levofloxacin Ocular Implant in Patients Undergoing Routine Bilateral Cataract Surgery
Scientific title
An Interventional, Open Label, Controlled, Randomized, Pairwise, Phase Ib Safety, Tolerability and Pharmacokinetic (PK) Study of Levofloxacin Ocular Implant in Patients Undergoing Routine Bilateral Cataract Surgery
Secondary ID [1] 0 0
LEVO-CS102
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataract 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Levofloxacin Ocular Implant
Treatment: Drugs - Control

Experimental: Levofloxacin Ocular Implant - Biphasic levofloxacin antibiotic implant

Active comparator: Control - Commercially available topical medications as per LEVO-CS102 Surgical Therapy Procedure.


Treatment: Drugs: 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.

Treatment: Drugs: Control
Commercially available topical medications as per LEVO-CS102 Surgical Therapy Procedure.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety of the Levofloxacin Ocular Implant
Timepoint [1] 0 0
Day 90
Primary outcome [2] 0 0
Levofloxacin concentration in aqueous humor at Day 5 in treated eyes
Timepoint [2] 0 0
Day 5
Secondary outcome [1] 0 0
Number of actuations required to administer the implant
Timepoint [1] 0 0
Day 0

Eligibility
Key inclusion criteria
Key Inclusion Criteria

1. Male or female subjects 18 years of age or older.
2. Willing and able to understand and sign an informed consent form prior to any study-related procedures.
3. Willing and able to follow study instructions, and able to be present for the required study visits/assessments for the duration of the study.
4. 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.
5. Minimum endothelial cell density (ECD) in both eyes of greater than or equal to 2000 cells per mm2.
6. Fully vaccinated against COVID-19, as evidenced by vaccination record.

Key Opthalmic
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

Ophthalmic:

1. 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.
2. 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.
3. Aphakia or low vision or monocular.
4. 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.
5. Use of prostaglandin (PG) analogues within 60 days prior to Screening or during the course of the study.
6. Subjects with clinically diagnosed Fuchs' Endothelial Corneal Dystrophy (FECD)/ history of keratoplasty.
7. Subjects for whom an intra-ocular or glaucoma device procedure is planned during the cataract procedure, during study participation or has been previously undertaken.
8. Have a current retinal detachment or history of blunt trauma in either eye.
9. Subject who in the opinion of the surgeon has a high risk of the posterior capsule being compromised/zonular dehiscence during cataract surgery.
10. 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.
11. 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).
12. Used fluoroquinolone antibiotics (topically, orally or systemically) during the 4 weeks before screening visit.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Withdrawn
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
23/06/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
14/03/2024
Actual
Sample size
Target
Accrual to date
Final
0
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Melbourne Eye Specialists - Fitzroy
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Missouri
Country [2] 0 0
United States of America
State/province [2] 0 0
South Carolina

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
PolyActiva Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Michael Coote, MD
Address 0 0
Melbourne Eye Specialists
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05441930