Open label controlled interventional study in eyes in up to 12 subjects (24 eyes) scheduled for uncomplicated bilateral cataract surgery on separate days.
This is a multicenter, open label, controlled, pairwise, interventional study in eyes in up to 12 subjects (24 eyes) scheduled for uncomplicated bilateral cataract surgery on separate days. Eligible individuals provide informed consent; and are screened for inclusion in the study. 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Levofloxacin Ocular Implant an implant that delivers a bolus dose of levofloxacin and a constant daily dose for a further 5-7 days.
Commercially available topical medications as per LEVO-CS102 Surgical Therapy Procedure.
Ophthalmology Associates
St Louis, Missouri, United States
Carolina Cataract and Laser Centre
Ladson, South Carolina, United States
Melbourne Eye Specialists
Fitzroy, Victoria, Australia
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
Time frame: 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.
Time frame: Day 5
Number of actuations required to administer the implant
Clinicians administering the implant will record the number of actuations required to use the custom-built administration device
Time frame: Day 0
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