Centre for Contact Lens Research, University of Waterloo
Waterloo, Ontario, N2L 3G1, Canada
NCT Number: NCT02756078
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.
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Notify Me18 year–40 year
All sexes
Interventional
Not applicable
Waterloo, Ontario, N2L 3G1, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: senofilcon A
Other names: samfilcon A
Time frame: Up to 4-Week Follow-up
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 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 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 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 lens wear time with the study lenses were recorded in hour at each follow-up visit.
Time frame: Up to 4-Week Follow-up
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
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.
Johnson & Johnson Vision Care, Inc.
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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