The primary objective is to determine the efficacy of ST266 eye drops in healing persistent epithelial defects (PED). After 8 weeks of randomized, double-blind treatment, non-healers will enter into an additional 8-week open-label ST266 treatment period. All patients will be followed for 3-months post-treatment for monitoring of safety and maintenance of re-epithelialization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8
Topical ocular application: one drop four times a day for eight weeks
Topical ocular application: one drop four times a day for eight weeks
Open label extension for non-healers after completion of double-blind treatment phase: topical ocular application of one drop four times a day for eight weeks
Clinical Success
Proportion of subjects with clinical success between ST266 and placebo arms, defined as complete re-epithelialization of the corneal epithelial defect by week 8 of treatment.
Time frame: 8 weeks
Safety of ST266
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) in subjects treated with ST266 versus placebo
Time frame: 7 months
Time to re-epithelialization
Time (in days) to first complete re-epithelization of PED in subjects treated with ST266 versus placebo.
Time frame: 8 weeks
Maintenance of re-epithelialization during treatment
Time (in days) of re-epithelialization maintenance during treatment.
Time frame: 8 weeks
Maintenance of re-epithelialization post-treatment
Maintenance of corneal re-epithelization at 2 weeks and up to 12 weeks after the end of treatment in subjects treated with ST266 versus placebo.
Time frame: 12 weeks
Change in BCVA from Baseline
Mean change in Best Corrected Visual Acuity (BCVA) from Baseline over time and maintenance up to 12 weeks after the end of treatment in subjects treated with ST266 versus placebo.
Time frame: 7 months
Incidence of Rescue Therapy
Incidence of need for rescue within 8 weeks in subjects treated with ST266 versus placebo.
Time frame: 8 weeks
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Clinical Success in Open-Label Extension
Proportion of subjects with complete re-epithelization of the corneal epithelial defect after 8 weeks of open label treatment based on the Independent Reading Center (IRC) image assessment.
Time frame: 8 weeks
Use of Lubricating Drops
Mean usage of preservative-free lubricating drops used for comfort in subjects treated with ST266 versus placebo.
Time frame: 8 weeks
VAS Score
Mean change in Visual Analog Scale (VAS) score from Baseline over time in subjects treated with ST266 versus placebo.
Time frame: 8 weeks
Size of Defect
Size of epithelial defect
Time frame: 7 months