A prospective randomized, and controlled study to compare the effectiveness of PROKERA® SLIM plus standard of care (SOC) in the PROKERA® SLIM Arm to SOC alone in the Control Arm. Subjects presenting with moderate DED defined as corneal fluorescein staining score of ≥ 3 points out of 9 will be recruited.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
3
PROKERA SLIM
Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)
Center of Excellence in Eye Care
Miami, Florida, United States
Corneal Fluorescein Staining
corneal fluorescein staining score of study eye graded from 0 to 9, with a score of 9 being worse. The corneal fluorescein staining score is the sum of three scores by subdividing the entire cornea into upper 1/3, middle 1/3, and lower 1/3, of which each is graded from 0 (no staining) to 3 (diffuse staining).
Time frame: 1 month
Eye Dryness Score
Patient subjectively evaluates eye dryness score using a visual analog scale from 0 to 100 maximal discomfort
Time frame: 1 month
Ocular Surface Disease Index (OSDI)
Patient subjectively evaluates OSDI questionnaire, OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability
Time frame: 1 month
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.