The clinical study is a randomized-controlled, double-masked, crossover clinical trial with two study treatments to compare two study lens types and the initial performance, in terms of the subjective response after a period of lens dispensing. The study will last approximately 2 to 4 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
45
Maitland Vision Center
Maitland, Florida, United States
Advanced Eyecare
Raytown, Missouri, United States
Spectrum Eyecare
Jamestown, New York, United States
Western Reserve Vision Care, Inc
Beachwood, Ohio, United States
CLUE Vision
Overall vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient experience attributes of soft contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Derived CLUE scores using Item Response Theory (IRT) follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0-120.
Time frame: 2-Week Follow-up
logMAR Visual Acuity
Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated under high luminance and high contrast conditions at three distances: Distance (3 meters) was measured using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; Intermediate (64 centimeters) and Near (40 centimeters) were measured using Reduced Guillon-Poling Charts. Letter-by-letter results calculated the visual performance score for each chart read. logMAR scores closer to zero, or below zero, indicate a better visual acuity. A logMAR visual performance score of 0.0 is equivalent to Snellen visual acuity of 20/20.
Time frame: 2-Week Follow-up
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
ProCare Vision Centers
Granville, Ohio, United States