The purpose of this study is to compare the subjective performance of comfilcon A lens against samfilcon A lens after 4 weeks of reusable lens wear.
This will be a 90 subject, randomized, bilateral, subject-masked, dispensing, cross-over study comparing comfilcon A versus samfilcon A lenses over 8 weeks of daily wear (2 x 4-weeks). Both eyes will wear the same lens (test or control) for 4 weeks in a randomized fashion. Subjects will be masked to lens type and investigators will be masked to the lens codes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Enrollment
90
contact lens
contact lens
Golden Optometric Group
Whittier, California, United States
Complete Eye Care of Medina
Medina, Minnesota, United States
Brock & Houlford
Chew Magna, Bristol, United Kingdom
Tempany's Boutique Opticians
Broadstone, Dorset, United Kingdom
Comfort
Subjective ratings of comfort (comfort after insertion, typical comfort just prior to removal, and overall comfort) for comfilcon A and samfilcon A assessed at baseline, 2 weeks, and 4 weeks. Scale of 0-10 (0=painful, 10=can't feel the lenses).
Time frame: Baseline, 2 weeks, 4 weeks
Comfortable Wearing Time Via SMS (Short Message Service)
Comfortable wearing times (WTs) via SMS (Short Message Service) for comfilcon A and samfilcon A lenses assessed at days 3, 12, and 26 at hours 8:00 am, 12:00 pm, 4:00 pm, and 8:00 pm. Scale of 0-10 (0=painful, 10=can't feel the lenses).
Time frame: Days 3, 12, 26
Wearing Times
Average wear time and comfortable wearing times (WTs) in hours for habitual, comfilcon A, and samfilcon A lenses.
Time frame: Baseline, 2 weeks, 4 weeks
Deterioration in Comfort
Deterioration of comfortable wearing time for habitual, comfilcon A, samfilcon A lenses. Subjects answered 'yes' or 'no' to the following question 'does contact lens comfort deteriorate during wear?'. Yes=deterioration in comfort present, No=deterioration in comfort absent
Time frame: Baseline, 2 weeks, 4 weeks
Vision Quality
Vision quality of comfilcon A and samfilcon A lenses. Scale 0-10, 0=completely dissatisfied, 10=completely satisfied.
Time frame: Baseline, 2 weeks, 4 weeks
Overall Lens Handling
Handling (ease of insertion and ease of removal) for comfilcon A and samfilcon A lenses. Scale 0-10, 0=very difficult to handle, 10=very easy to handle.
Time frame: Baseline, 2 weeks, 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
David Gould Opticians
Rawtenstall, Lancashire, United Kingdom
Biomicroscopy Scores
Biomicroscopy for comfilcon A and samfilcon A lens assessed. Scale 0-4 in 0.5 steps 0=none, 1=trace, 2=mild, 3=moderate, 4=severe
Time frame: Baseline, 2 weeks, 4 weeks
Lens Surface Wetting
Lens surface wettability assessment for comfilcon A and samfilcon A lenses. Scale 0-4 in 0.5 steps, 0=very poor, 4=excellent
Time frame: Baseline, 2 weeks, 4 weeks
Film Deposits
Front surface film deposits for comfilcon A and samfilcon A lenses. Scale 0-4, 0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=Heavy film visible to the naked eye.
Time frame: 2 weeks and 4 weeks
White Spot Deposits
Number of white spot deposits for comfilcon A and samfilcon A lenses.
Time frame: 2 weeks and 4 weeks
Visual Acuity (VA)
Visual acuity (VA) for comfilcon A and samfilcon A lens wear is assessed using Snellen.
Time frame: Baseline, 2 weeks, 4 weeks
Lens Centration
Lens centration will be recorded by degree and direction in the primary position. 0=Centered -optimal, 1=Decentered slightly, 2=Substantially decentered (\>0.5mm)
Time frame: Baseline, 2 weeks, 4 weeks
Corneal Coverage
Investigator assessment of corneal coverage for comfilcon A and samfilcon A lenes. Yes = coverage at all times or No = coverage incomplete
Time frame: Baseline Visit, 2 weeks follow-up, 4-weeks follow-up
Post-Blink Movement
Post-blink movement for comifilcon A and samfilcon A lenses are assessed. 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement
Time frame: Baseline, 2 weeks, 4 weeks
Primary Gaze Lag
Investigator assessment of primary gaze lag for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement
Time frame: Baseline, 2 weeks, and 4 weeks
Lens Tightness Push-up
Investigator assessment of lens tightness push-up for comfilcon A and samfilcon A lenses. Scale 0%-100% continuous scale, 100%=No movement, 50%=Optimum, 0%=Falls from cornea without lid support
Time frame: Baseline, 2 weeks, 4 weeks
Overall Fit Acceptance
Overall fit acceptance for comfilcon A and samfilcon A lenses. Scale 0-4, 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimum acceptable, early review, 3=Not perfect but okay to dispense, 4=Perfect
Time frame: Baseline, 2 weeks, 4 weeks
Dryness
Subjective response of dryness for comfilcon A and samfilcon A lenses during a typical day of wear and prior to removal. Scale of 0-10, 10=No dryness, 0=Extremely dry
Time frame: Baseline, 2 weeks, 4 weeks