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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04682288




Registration number
NCT04682288
Ethics application status
Date submitted
8/11/2020
Date registered
23/12/2020
Date last updated
8/12/2021

Titles & IDs
Public title
Levofloxacin Ocular Implant for Ocular Surgery
Scientific title
An Interventional, Open Label, Non-randomized, Phase Ia Safety and Tolerability Study of Levofloxacin Ocular Implant in Subjects Undergoing Routine Cataract Surgery.
Secondary ID [1] 0 0
LEVO-CS101
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

Experimental: Levofloxacin Ocular Implant - Biphasic levofloxacin antibiotic implant


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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Ocular Inflammation
Timepoint [1] 0 0
90 days
Primary outcome [2] 0 0
Endothelial Cell Density
Timepoint [2] 0 0
90 days
Primary outcome [3] 0 0
Intraocular Pressure (IOP)
Timepoint [3] 0 0
90 days
Secondary outcome [1] 0 0
Administration procedure
Timepoint [1] 0 0
1 week

Eligibility
Key inclusion criteria
- Diagnosis of cataract in the intent to treat eye

- Endothelial cell density in the study eye of at least 2000 cells per mm2
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- history of ocular inflammation including, macular degeneration, uveitis, macular edema
or corneal edema

- recent surgery in the study eye

- subjects receiving a glaucoma device in conjunction with cataract surgery

- subjects with a compromised posterior capsule during surgery

- corneal disease that prevents effective imaging of endothelium including Fuch's
Dystrophy.

- sensitivity to fluoroquinolones

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
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
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/01/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/10/2021
Sample size
Target
Accrual to date
Final
5
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
This is a multi center, open label, interventional study in one eye of 5 subjects scheduled
for uncomplicated cataract surgery with administration of a single Levofloxacin Ocular
Implant in the posterior sulcus of the surgical eye at the end of cataract surgery.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04682288
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joseph Gira, MD
Address 0 0
Opthalmology Consultants Ltd
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04682288