This is a randomized, double-masked dispensing study where subjects will randomized into one of two lens sequences to wear each of two contact lens types for a 4-week period with each lens type.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
200
Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, Canada
Overall CLUE Comfort
Overall comfort 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.
Time frame: Up to 4-Week Follow-up
Overall CLUE Handling
Overall Handling 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.
Time frame: Up to 4-Week Follow-up
Time to Haze
Time to haze measure the maximum time a contact lens wearers can keep their eye open without their vision becoming hazy. It was a measure of how the drying of the contact lens surface with open eyes affects vision.
Time frame: Up to 4-Week Follow-up
Average Wear Time
Average lens wear time with the study lenses were recorded in hour at each follow-up visit.
Time frame: Up to 4-Week Follow-up
Average Comfortable Wear Time
Average comfortable lens wear time with the study lenses were recorded in hour at each follow-up visit.
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Time frame: Up to 4-Week Follow-up
Difference in Total Device Use Time and Comfortable Wear Time During Device Use
Subjects reported the total duration of their digital device use and comfortable lens wear time during digital device use.
Time frame: Up to 4-Week Follow-up
Comfort at the End of the Day
Subjects graded the comfort level at the end of the day using 5- point scale (1=excellence, 2=very good, 3=good, 4=fair and 5=poor). The average end of day comfort grade was reported for each lens type.
Time frame: Up to 4-Week Follow-up