Levofloxacin Ocular Implant for Ocular Surgery

Cataract Clinical Trial

Official title:

An Interventional, Open Label, Non-randomized, Phase Ia Safety and Tolerability Study of Levofloxacin Ocular Implant in Subjects Undergoing Routine Cataract Surgery.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04682288
• Other study ID #: LEVO-CS101
• Status: Completed
• Phase: Phase 1
• Start date: January 4, 2021
• Est. completion date: October 14, 2021

Study information

• Verified date: December 2021
• Source: PolyActiva Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: October 14, 2021
• Est. primary completion date: October 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Cataract

Intervention

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.

Locations

Country	Name	City	State
Australia	Melbourne Eye Specialists	Fitzroy	Victoria
United States	Carolina Cataract and Laser Centre	Ladson	South Carolina
United States	Ophthalmology Consultants Ltd	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
PolyActiva Pty Ltd

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular Inflammation	Change assessed according to Standardization of Uveitis Nomenclature (SUN) Grading Scale	90 days
Primary	Endothelial Cell Density	Change in number of central corneal endothelial cells per mm2	90 days
Primary	Intraocular Pressure (IOP)	Change in IOP measured by Goldmann applenation tonometry	90 days
Secondary	Administration procedure	Number of actuation's required to expel implant	1 week