Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses

Study Overview
=================
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.

Official Title
-----------------
Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: comfilcon A
* Device: samfilcon A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Spherical distance Contact Lens prescription between -1.00 and -6.00D or +1.00 to +4.00D in both eyes (inclusive) Adapted soft Contact Lens wearers (i.e. >1 month), daily disposable and reusable lens wearers. Spectacle cylinder 0.75D in both eyes. Correctable to 6/9 (20/30) in both eyes Be between 18 and 50 years of age (inclusive) Able to read, comprehend and sign an informed consent Own a mobile phone and be willing to respond to Short Message Service (SMS) survey Willing to comply with the wear and study visit schedule Exclusion: Existing Biofinity or Ultra wearers Any active corneal infection, injury or inflammation Systemic or ocular allergies, which might interfere with Contact Lens wear Systemic disease, which might interfere with Contact Lens wear Ocular disease, which might interfere with Contact Lens wear Strabismus or amblyopia Subjects who have undergone corneal refractive surgery Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear Pregnant or lactating Use of systemic/topical medication contraindicating Contact Lens wear Diabetic Site employees or family members of site employees

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: comfilcon A<br>Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study. | Device: comfilcon A<br>* contact lens<br>|
| Active Comparator: samfilcon A<br>Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study. | Device: samfilcon A<br>* contact lens<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Baseline, 2 weeks, 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | Days 3, 12, 26 | 
| Wearing Times | Average wear time and comfortable wearing times (WTs) in hours for habitual, comfilcon A, and samfilcon A lenses. | 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 | 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. | 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. | Baseline, 2 weeks, 4 weeks | 
| 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 | 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 | 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. | 2 weeks and 4 weeks | 
| White Spot Deposits | Number of white spot deposits for comfilcon A and samfilcon A lenses. | 2 weeks and 4 weeks | 
| Visual Acuity (VA) | Visual acuity (VA) for comfilcon A and samfilcon A lens wear is assessed using Snellen. | 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) | 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 | 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 | 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 | 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 | 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 | 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 | Baseline, 2 weeks, 4 weeks |