This study is a feasibility, multi-site, randomized, double-masked, 2-arm parallel group design, 2-week dispensing study with weekly visits to evaluate visual acuity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
123
VRC
Jacksonville, Florida, United States
Flora Chen Poveda OD, PA - Orange Park
Orange Park, Florida, United States
Tallahassee Eye Center
Tallahassee, Florida, United States
Sacco Eye Group
Vestal, New York, United States
Monocular logMAR Visual Acuity
Monocular visual acuity was measured on a logMAR (Logarithm of Minimal Angle of Resolution) scale under high luminance low contrast (HLLC), and low luminance high contrast (LLHC) at distance (4 meters) using an 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: 2-Week Follow-up
Average Daily Wearing Time
Average daily wear time was assessed by calculating the number of hours between subjects reported time of insertion and time of removal of the study lenses, on an average day.
Time frame: 2-Week Follow-up
CLUE Comfort Score
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 comfort score for each lens type was reported.
Time frame: 2-Week Follow-up
CLUE Vision Score
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.
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William J. Bogus, O.D.
Salt Lake City, Utah, United States
Botetourt Eyecare, LLC
Salem, Virginia, United States
Time frame: 2-Week Follow-up