In this phase II randomized double-masked clinical trials, subjects with non-resolving corneal epithelial disease/defect (i.e., refractory to standard treatments for at least two weeks) will receive 8 weeks treatment of topical mesenchymal stem cell secretome or vehicle, with continued follow-up for up to Day 70.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
24
Eye Drops
University of Illinois at Chicago
Chicago, Illinois, United States
RECRUITINGImprovement of Corneal Epithelial Barrier and/or Integrity (Efficacy Outcome)
Proportion of subjects with improved epithelial barrier and/or integrity from baseline to DAY 56 as determined by the investigator on slit lamp examination: · Improved epithelial barrier, defined as ³ 50 % improvement in corneal fluorescein staining score using NEI grading scale · Improved epithelial integrity, defined as complete closure of persistent epithelial defect, measured with ImageJ on slit lamp images
Time frame: Baseline to Day 56
Visual Acuity
Percent change in best-corrected distance visual acuity from baseline to DAY 56 as measured using standard ETDRS protocols
Time frame: Baseline to Day 56
Corneal staining and NEI grading
Grading of fluorescein staining of the cornea Minimum score = 0 Maximum score = 15 Lower score is better
Time frame: Baseline to Day 70
Ocular Surface Parameters
Changes in ocular surface disease index (OSDI) from baseline to DAY 56 and DAY 70 Minimum value = 0 Maximum value = 100 Lower value is better
Time frame: Baseline to Day 70
Corneal Epithelial Thickness
Percent change in corneal epithelial thickness from baseline to DAY 56 and DAY 70, as measured by anterior segment OCT (AS-OCT)
Time frame: Baseline to Day 70
Subject Symptoms
Changes in ocular discomfort visual analog scale (VAS) 0 - 100, where 0 is no discomfort and 100 the worst discomfort, from baseline to DAY 70
Time frame: Baseline to Day 70
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Time to epithelial healing
Time of improvement of epitheliopathy
Time frame: Baseline to Day 70
Corneal Opacities/Scars
Change in the size of corneal opacities and scars (if present) from baseline to DAY 56 as documented by slit lamp photographs
Time frame: Baseline to Day 56
Corneal vascularization
Change in corneal vascularization on slit lamp photographs from baseline to DAY 56
Time frame: Baseline to Day 56
Conjunctival injection
Change in conjunctival injection on slit lamp examination from baseline to DAY 56
Time frame: Baseline to Day 56
Subbasal corneal nerve density
Changes in subbasal corneal nerve density on confocal microscopy from baseline to Day 56
Time frame: Baseline to Day 56
Ocular Surface Parameters
Changes in Lissamine green staining from baseline to DAY 56 and DAY 70
Time frame: Baseline to Day 70
Ocular Surface Parameters
Changes in anesthetic Schirmer's test from baseline to DAY 56 and DAY 70
Time frame: Baseline to Day 70