This is a single-masked, crossover, randomized-controlled, dispensing clinical trial. A total of approximately 70 myopic eligible subjects will be targeted to complete the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
67
Dr. James Weber & Associates, PA
Jacksonville, Florida, United States
VRC-East
Jacksonville, Florida, United States
Maitland Vision Center
Maitland, Florida, United States
Kannarr Eye Care
Pittsburg, Florida, United States
Subjective Vision Scores
Subjective Overall Quality of Vision was assessed using the Contact Lens User Experience™ (CLUE) questionnaire. CLUE is a validated patient-reported outcomes (PRO) questionnaire to assess patient- xperience 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: 1-Week Follow-up
Visual Acuity (logMAR)
High contrast bright illumination binocular logMAR (Logarithm of the Minimum Angle of Resolution) visual acuity was assessed at distance (4 meters) using ETDRS Charts, near (40 cm) and intermediate (64 cm) using reduced Guillon-Poling charts. A value of 0.0 logMAR indicated a Snellen vision of 20/20. Lower logMAR visual acuity values indicates better vision. The average logMAR visual acuity for each lens was reported. Note: The room illuminance was required to be between 7.3 and 7.9 EV (394-597 lux). Acceptable Luminance Range for Distance (4M): 10.5-10.7 EV (181-208 cd/m2). Acceptable Luminance Range for Near (40cm) and Intermediate Guillon-Poling :10.8- 11.1 EV (223-274 cd/m2).
Time frame: 1-Week Follow-up
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Visual Eyes
Roswell, Georgia, United States
ProCare Vision Centers
Granville, Ohio, United States
West Bay Eye Associates
Warwick, Rhode Island, United States