Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses
- Conditions
- Myopia
- Interventions
- Device: comfilcon ADevice: samfilcon A
- Registration Number
- NCT02542072
- Lead Sponsor
- Coopervision, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description comfilcon A comfilcon A Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study. samfilcon A samfilcon A Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.
- Primary Outcome Measures
Name Time Method Comfort Baseline, 2 weeks, 4 weeks 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).
- Secondary Outcome Measures
Name Time Method Wearing Times Baseline, 2 weeks, 4 weeks Average wear time and comfortable wearing times (WTs) in hours for habitual, comfilcon A, and samfilcon A lenses.
Biomicroscopy Scores Baseline, 2 weeks, 4 weeks 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
Deterioration in Comfort Baseline, 2 weeks, 4 weeks 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
Overall Lens Handling Baseline, 2 weeks, 4 weeks 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.
Film Deposits 2 weeks and 4 weeks 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.
Comfortable Wearing Time Via SMS (Short Message Service) Days 3, 12, 26 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).
Vision Quality Baseline, 2 weeks, 4 weeks Vision quality of comfilcon A and samfilcon A lenses. Scale 0-10, 0=completely dissatisfied, 10=completely satisfied.
Visual Acuity (VA) Baseline, 2 weeks, 4 weeks Visual acuity (VA) for comfilcon A and samfilcon A lens wear is assessed using Snellen.
Lens Centration Baseline, 2 weeks, 4 weeks Lens centration will be recorded by degree and direction in the primary position. 0=Centered -optimal, 1=Decentered slightly, 2=Substantially decentered (\>0.5mm)
Corneal Coverage Baseline Visit, 2 weeks follow-up, 4-weeks follow-up Investigator assessment of corneal coverage for comfilcon A and samfilcon A lenes.
Yes = coverage at all times or No = coverage incompletePost-Blink Movement Baseline, 2 weeks, 4 weeks 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
Lens Tightness Push-up Baseline, 2 weeks, 4 weeks 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 supportDryness Baseline, 2 weeks, 4 weeks 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
Lens Surface Wetting Baseline, 2 weeks, 4 weeks Lens surface wettability assessment for comfilcon A and samfilcon A lenses. Scale 0-4 in 0.5 steps, 0=very poor, 4=excellent
White Spot Deposits 2 weeks and 4 weeks Number of white spot deposits for comfilcon A and samfilcon A lenses.
Primary Gaze Lag Baseline, 2 weeks, and 4 weeks 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
Overall Fit Acceptance Baseline, 2 weeks, 4 weeks 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
Trial Locations
- Locations (5)
David Gould Opticians
🇬🇧Rawtenstall, Lancashire, United Kingdom
Golden Optometric Group
🇺🇸Whittier, California, United States
Complete Eye Care of Medina
🇺🇸Medina, Minnesota, United States
Tempany's Boutique Opticians
🇬🇧Broadstone, Dorset, United Kingdom
Brock & Houlford
🇬🇧Chew Magna, Bristol, United Kingdom