Back to resultsLevofloxacin Ocular Implant for Ocular Surgery
Primary Purpose
Cataract
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Levofloxacin Ocular Implant
Sponsored by
About this trial
This is an interventional treatment trial for Cataract
Eligibility Criteria
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
Sites / Locations
- Ophthalmology Consultants Ltd
- Carolina Cataract and Laser Centre
- Melbourne Eye Specialists
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Levofloxacin Ocular Implant
Arm Description
Biphasic levofloxacin antibiotic implant
Outcomes
Primary Outcome Measures
Ocular Inflammation
Change assessed according to Standardization of Uveitis Nomenclature (SUN) Grading Scale
Endothelial Cell Density
Change in number of central corneal endothelial cells per mm2
Intraocular Pressure (IOP)
Change in IOP measured by Goldmann applenation tonometry
Secondary Outcome Measures
Administration procedure
Number of actuation's required to expel implant
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04682288
Brief Title
Levofloxacin Ocular Implant for Ocular Surgery
Official Title
An Interventional, Open Label, Non-randomized, Phase Ia Safety and Tolerability Study of Levofloxacin Ocular Implant in Subjects Undergoing Routine Cataract Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
October 14, 2021 (Actual)
Study Completion Date
October 14, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
PolyActiva Pty Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levofloxacin Ocular Implant
Arm Type
Experimental
Arm Description
Biphasic levofloxacin antibiotic implant
Intervention Type
Drug
Intervention Name(s)
Levofloxacin Ocular Implant
Intervention Description
Levofloxacin Ocular Implant an implant that delivers a bolus dose of levofloxacin and a constant daily dose for a further 5-7 days.
Primary Outcome Measure Information:
Title
Ocular Inflammation
Description
Change assessed according to Standardization of Uveitis Nomenclature (SUN) Grading Scale
Time Frame
90 days
Title
Endothelial Cell Density
Description
Change in number of central corneal endothelial cells per mm2
Time Frame
90 days
Title
Intraocular Pressure (IOP)
Description
Change in IOP measured by Goldmann applenation tonometry
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Administration procedure
Description
Number of actuation's required to expel implant
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Gira, MD
Organizational Affiliation
Opthalmology Consultants Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ophthalmology Consultants Ltd
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Carolina Cataract and Laser Centre
City
Ladson
State/Province
South Carolina
ZIP/Postal Code
29456
Country
United States
Facility Name
Melbourne Eye Specialists
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Levofloxacin Ocular Implant for Ocular Surgery
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