This is a single-masked, two-arm, parallel-group, randomized-controlled, dispensing clinical trial to evaluate the visual performance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
77
TEST Lens
CONTROL Lens
Stam & Associates Eye Care
Jacksonville, Florida, United States
Sabal Eye Care
Longwood, Florida, United States
Visual Eyes
Roswell, Georgia, United States
Kannarr Eye Care
Pittsburg, Kansas, United States
Binocular logMAR Visual Acuity
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance high contrast condition. At distance (4 meters), VA is assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) charts; while near (40 cm) and intermediate (64 cm) assessments were made 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: 1-Week Follow-up
CLUE Vision Score
Subjective vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patientreported 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
Binocular Distance logMAR Visual Acuity
Binocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale at distance (4m) under high luminance high contrast condition assessed using ETDRS (Early Treatment Diabetic Retinopathy Study) 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: 1-Week Follow-up
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Birmingham Vision Care
Bloomfield Township, Michigan, United States
Eye Associates of New York
New York, New York, United States
ProCare Vision Centers
Granville, Ohio, United States
West Bay Eye Associates
Warwick, Rhode Island, United States
Tyler Eye Associates
Tyler, Texas, United States