This is a single-masked, 2×3 crossover, randomized, dispensing clinical trial to evaluate the visual performance and subjective responses of the JJVC Investigational Contact Lens.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
78
senofilcon A C3
delefilcon A
VRC-East
Jacksonville, Florida, United States
St. Johns Eye Associates, PA
Saint Augustine, Florida, United States
Advanced Eyecare
Raytown, Missouri, United States
Spectrum Eyecare
Jamestown, New York, United States
Visual Performance (logMAR)
Binocular visual performance on logMAR (Logarithm of Minimal Angle of Resolution) scale was evaluated at distance (4 m), intermediate (64 cm) and near (40 cm) under high luminance high contrast lighting conditions using ETDRS (Early Treatment Diabetic Retinopathy Study) charts. The room illuminance was required to be between 7.3 and 7.9 EV (394-597 lux). For Distance (4 m), the acceptable range for the chart luminance was 10.5-10.7 EV (181-208 cd/m2). For Intermediate (64cm) and Near (40cm), the cceptable range for the chart luminance 10.8-11.1 EV (223-274 cd/m2). 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. The average score was reported for each lens.
Time frame: 1-Week Follow-up
CLUE Vision
Subjective 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. The average CLUE vision score for each lens type was reported.
Time frame: 1-Week Follow-up
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Sacco Eye Group
Vestal, New York, United States
ProCare Vision Centers
Granville, Ohio, United States
Tyler Eye Associates
Tyler, Texas, United States