This is a bilateral, 2-week dispensing, randomized, controlled, subject-masked, 2×2 crossover study to evaluate the clinical performance of prototype contact lenses with experimental UV/HEV-blocker.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
228
JJVC Investigational Contact Lens
ACUVUE Oasys 1-Day
Dr. James Weber & Associates, PA
Jacksonville, Florida, United States
Flora Chen Poveda, OD, PA
Orange Park, Florida, United States
Tallahassee Eye Center
Tallahassee, Florida, United States
Overall Quality of Vision Score
Overall quality of vision scores were 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: 2-Week Follow-up
Overall Comfort Scores
Overall comfort scores were 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
Overall Handling Scores
Overall handling scores were 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 handling score for each lens type was reported.
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.
Visual Eyes
Roswell, Georgia, United States
Birmingham Vision Care
Bloomfield Township, Michigan, United States
Complete Eye Care of Medina
Medina, Minnesota, United States
Dr. Debbie H. Kim, OD
Closter, New Jersey, United States
Professional Vision Care, Inc.
Westerville, Ohio, United States
Optometry Group, LLC
Memphis, Tennessee, United States
Gulf Coast Vision Center, Inc.
Houston, Texas, United States
...and 2 more locations