Myopia
Conditions
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.
Interventions
DEVICEcomfilcon A
contact lens
DEVICEsamfilcon A
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Post-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 |
| 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). |
| 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. |
| 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 |
| 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. |
| 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. |
| 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 |
| 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 |
| 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 incomplete |
| White Spot Deposits | 2 weeks and 4 weeks | Number of white spot deposits for comfilcon A and samfilcon A lenses. |
| 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) |
| 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 |
| 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 support |
| 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 |
| Dryness | 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 |
| 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. |
Countries
United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Comfilcon A, Then Samfilcon A Randomized participants who wore the comfilcon A lens pair for one month, then samfilcon A lens pair during the cross over study.
comfilcon A: contact lenses
samfilcon A: contact lenses | 44 |
| Samfilcon A, Then Comfilcon A Randomized participants who wore the samfilcon A lens pair for one month, then comfilcon A lens pair during the cross over study.
comfilcon A: contact lenses
samfilcon A: contact lenses | 46 |
| Total | 90 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention (1 Month) | Adverse Event | 1 | 1 |
| First Intervention (1 Month) | Lens discomfort | 1 | 2 |
| First Intervention (1 Month) | Lost to Follow-up | 2 | 0 |
| First Intervention (1 Month) | Protocol Violation | 1 | 0 |
| Second Intervention (1 Month) | Lens discomfort | 1 | 0 |
| Second Intervention (1 Month) | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Comfilcon A, Then Samfilcon A | Samfilcon A, Then Comfilcon A | Total |
|---|---|---|---|
| Age, Continuous | 32.1 years STANDARD_DEVIATION 9.3 | 30.8 years STANDARD_DEVIATION 8 | 31.4 years STANDARD_DEVIATION 8.7 |
| Sex: Female, Male Female | 28 Participants | 34 Participants | 62 Participants |
| Sex: Female, Male Male | 16 Participants | 12 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 90 | 0 / 90 |
| serious Total, serious adverse events | 0 / 90 | 0 / 90 |
Outcome results
Primary
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
Population: Number of participants analyzed is different from participant flow due to protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lens (Baseline) | Comfort | Comfort after insertion | 8.85 units on a scale | Standard Deviation 1.92 |
| Habitual Lens (Baseline) | Comfort | Overall comfort | 8.80 units on a scale | Standard Deviation 1.75 |
| Habitual Lens (Baseline) | Comfort | Typical comfort just prior to removal | 7.72 units on a scale | Standard Deviation 2.06 |
| Comfilcon A (2 Weeks) | Comfort | Typical comfort just prior to removal | 7.68 units on a scale | Standard Deviation 2.11 |
| Comfilcon A (2 Weeks) | Comfort | Comfort after insertion | 9.06 units on a scale | Standard Deviation 1.4 |
| Comfilcon A (2 Weeks) | Comfort | Overall comfort | 8.33 units on a scale | Standard Deviation 1.81 |
| Samfilcon A (2 Weeks) | Comfort | Typical comfort just prior to removal | 7.09 units on a scale | Standard Deviation 2.3 |
| Samfilcon A (2 Weeks) | Comfort | Comfort after insertion | 8.71 units on a scale | Standard Deviation 1.81 |
| Samfilcon A (2 Weeks) | Comfort | Overall comfort | 7.90 units on a scale | Standard Deviation 1.9 |
| Comfilcon A (4 Weeks) | Comfort | Comfort after insertion | 8.84 units on a scale | Standard Deviation 1.56 |
| Comfilcon A (4 Weeks) | Comfort | Overall comfort | 8.01 units on a scale | Standard Deviation 1.95 |
| Comfilcon A (4 Weeks) | Comfort | Typical comfort just prior to removal | 7.38 units on a scale | Standard Deviation 2.32 |
| Samfilcon A (4 Weeks) | Comfort | Typical comfort just prior to removal | 6.94 units on a scale | Standard Deviation 2.22 |
| Samfilcon A (4 Weeks) | Comfort | Comfort after insertion | 8.60 units on a scale | Standard Deviation 1.8 |
| Samfilcon A (4 Weeks) | Comfort | Overall comfort | 7.76 units on a scale | Standard Deviation 1.76 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lens (Baseline) | Biomicroscopy Scores | Corneal Staining | 0.39 units on a scale | Standard Deviation 0.55 |
| Habitual Lens (Baseline) | Biomicroscopy Scores | Limbal Hyperaemia | 0.39 units on a scale | Standard Deviation 0.39 |
| Habitual Lens (Baseline) | Biomicroscopy Scores | Conjunctival fluorescein staining | 0.67 units on a scale | Standard Deviation 0.61 |
| Habitual Lens (Baseline) | Biomicroscopy Scores | Bulbar Hyperaemia | 0.67 units on a scale | Standard Deviation 0.53 |
| Habitual Lens (Baseline) | Biomicroscopy Scores | Palpebral Conjunctiva | 0.53 units on a scale | Standard Deviation 0.59 |
| Comfilcon A (2 Weeks) | Biomicroscopy Scores | Corneal Staining | 0.63 units on a scale | Standard Deviation 0.66 |
| Comfilcon A (2 Weeks) | Biomicroscopy Scores | Palpebral Conjunctiva | 0.73 units on a scale | Standard Deviation 0.75 |
| Comfilcon A (2 Weeks) | Biomicroscopy Scores | Bulbar Hyperaemia | 0.60 units on a scale | Standard Deviation 0.58 |
| Comfilcon A (2 Weeks) | Biomicroscopy Scores | Conjunctival fluorescein staining | 0.75 units on a scale | Standard Deviation 0.66 |
| Comfilcon A (2 Weeks) | Biomicroscopy Scores | Limbal Hyperaemia | 0.42 units on a scale | Standard Deviation 0.5 |
| Samfilcon A (2 Weeks) | Biomicroscopy Scores | Palpebral Conjunctiva | 0.72 units on a scale | Standard Deviation 0.85 |
| Samfilcon A (2 Weeks) | Biomicroscopy Scores | Limbal Hyperaemia | 0.45 units on a scale | Standard Deviation 0.45 |
| Samfilcon A (2 Weeks) | Biomicroscopy Scores | Bulbar Hyperaemia | 0.67 units on a scale | Standard Deviation 0.57 |
| Samfilcon A (2 Weeks) | Biomicroscopy Scores | Corneal Staining | 0.56 units on a scale | Standard Deviation 0.63 |
| Samfilcon A (2 Weeks) | Biomicroscopy Scores | Conjunctival fluorescein staining | 1.23 units on a scale | Standard Deviation 0.69 |
| Comfilcon A (4 Weeks) | Biomicroscopy Scores | Conjunctival fluorescein staining | 0.81 units on a scale | Standard Deviation 0.67 |
| Comfilcon A (4 Weeks) | Biomicroscopy Scores | Limbal Hyperaemia | 0.47 units on a scale | Standard Deviation 0.48 |
| Comfilcon A (4 Weeks) | Biomicroscopy Scores | Corneal Staining | 0.69 units on a scale | Standard Deviation 0.7 |
| Comfilcon A (4 Weeks) | Biomicroscopy Scores | Palpebral Conjunctiva | 0.79 units on a scale | Standard Deviation 0.77 |
| Comfilcon A (4 Weeks) | Biomicroscopy Scores | Bulbar Hyperaemia | 0.61 units on a scale | Standard Deviation 0.57 |
| Samfilcon A (4 Weeks) | Biomicroscopy Scores | Palpebral Conjunctiva | 0.78 units on a scale | Standard Deviation 0.79 |
| Samfilcon A (4 Weeks) | Biomicroscopy Scores | Corneal Staining | 0.56 units on a scale | Standard Deviation 0.72 |
| Samfilcon A (4 Weeks) | Biomicroscopy Scores | Limbal Hyperaemia | 0.49 units on a scale | Standard Deviation 0.46 |
| Samfilcon A (4 Weeks) | Biomicroscopy Scores | Conjunctival fluorescein staining | 1.19 units on a scale | Standard Deviation 0.71 |
| Samfilcon A (4 Weeks) | Biomicroscopy Scores | Bulbar Hyperaemia | 0.62 units on a scale | Standard Deviation 0.52 |
Secondary
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
Population: Number of participants analyzed may differ from participant flow due to protocol deviations.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lens (Baseline) | Comfortable Wearing Time Via SMS (Short Message Service) | 8:00 am | 8.59 units on a scale | Standard Deviation 1.85 |
| Habitual Lens (Baseline) | Comfortable Wearing Time Via SMS (Short Message Service) | 12:00 pm | 8.97 units on a scale | Standard Deviation 1.26 |
| Habitual Lens (Baseline) | Comfortable Wearing Time Via SMS (Short Message Service) | 4:00 pm | 8.56 units on a scale | Standard Deviation 1.8 |
| Habitual Lens (Baseline) | Comfortable Wearing Time Via SMS (Short Message Service) | 8:00 pm | 8.53 units on a scale | Standard Deviation 1.52 |
| Comfilcon A (2 Weeks) | Comfortable Wearing Time Via SMS (Short Message Service) | 4:00 pm | 8.65 units on a scale | Standard Deviation 1.53 |
| Comfilcon A (2 Weeks) | Comfortable Wearing Time Via SMS (Short Message Service) | 12:00 pm | 9.07 units on a scale | Standard Deviation 1.03 |
| Comfilcon A (2 Weeks) | Comfortable Wearing Time Via SMS (Short Message Service) | 8:00 am | 8.82 units on a scale | Standard Deviation 1.61 |
| Comfilcon A (2 Weeks) | Comfortable Wearing Time Via SMS (Short Message Service) | 8:00 pm | 8.30 units on a scale | Standard Deviation 1.59 |
| Samfilcon A (2 Weeks) | Comfortable Wearing Time Via SMS (Short Message Service) | 8:00 pm | 8.06 units on a scale | Standard Deviation 1.93 |
| Samfilcon A (2 Weeks) | Comfortable Wearing Time Via SMS (Short Message Service) | 4:00 pm | 8.19 units on a scale | Standard Deviation 1.84 |
| Samfilcon A (2 Weeks) | Comfortable Wearing Time Via SMS (Short Message Service) | 12:00 pm | 8.71 units on a scale | Standard Deviation 1.87 |
| Samfilcon A (2 Weeks) | Comfortable Wearing Time Via SMS (Short Message Service) | 8:00 am | 8.90 units on a scale | Standard Deviation 1.46 |
| Comfilcon A (4 Weeks) | Comfortable Wearing Time Via SMS (Short Message Service) | 8:00 am | 8.84 units on a scale | Standard Deviation 1.36 |
| Comfilcon A (4 Weeks) | Comfortable Wearing Time Via SMS (Short Message Service) | 8:00 pm | 7.84 units on a scale | Standard Deviation 2.21 |
| Comfilcon A (4 Weeks) | Comfortable Wearing Time Via SMS (Short Message Service) | 12:00 pm | 8.55 units on a scale | Standard Deviation 1.83 |
| Comfilcon A (4 Weeks) | Comfortable Wearing Time Via SMS (Short Message Service) | 4:00 pm | 8.03 units on a scale | Standard Deviation 1.98 |
| Samfilcon A (4 Weeks) | Comfortable Wearing Time Via SMS (Short Message Service) | 4:00 pm | 8.06 units on a scale | Standard Deviation 1.85 |
| Samfilcon A (4 Weeks) | Comfortable Wearing Time Via SMS (Short Message Service) | 8:00 pm | 7.87 units on a scale | Standard Deviation 2.25 |
| Samfilcon A (4 Weeks) | Comfortable Wearing Time Via SMS (Short Message Service) | 12:00 pm | 8.44 units on a scale | Standard Deviation 1.74 |
| Samfilcon A (4 Weeks) | Comfortable Wearing Time Via SMS (Short Message Service) | 8:00 am | 8.98 units on a scale | Standard Deviation 1.45 |
| Samfilcon A (Day 26) | Comfortable Wearing Time Via SMS (Short Message Service) | 12:00 pm | 8.11 units on a scale | Standard Deviation 2.12 |
| Samfilcon A (Day 26) | Comfortable Wearing Time Via SMS (Short Message Service) | 4:00 pm | 8.07 units on a scale | Standard Deviation 1.63 |
| Samfilcon A (Day 26) | Comfortable Wearing Time Via SMS (Short Message Service) | 8:00 pm | 7.82 units on a scale | Standard Deviation 2.09 |
| Samfilcon A (Day 26) | Comfortable Wearing Time Via SMS (Short Message Service) | 8:00 am | 8.51 units on a scale | Standard Deviation 1.67 |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens (Baseline) | Corneal Coverage | Yes | 100.0 percentage of eyes |
| Habitual Lens (Baseline) | Corneal Coverage | No | 0.0 percentage of eyes |
| Comfilcon A (2 Weeks) | Corneal Coverage | Yes | 100.0 percentage of eyes |
| Comfilcon A (2 Weeks) | Corneal Coverage | No | 0.0 percentage of eyes |
| Samfilcon A (2 Weeks) | Corneal Coverage | Yes | 100.0 percentage of eyes |
| Samfilcon A (2 Weeks) | Corneal Coverage | No | 0.0 percentage of eyes |
| Comfilcon A (4 Weeks) | Corneal Coverage | Yes | 100.0 percentage of eyes |
| Comfilcon A (4 Weeks) | Corneal Coverage | No | 0.0 percentage of eyes |
| Samfilcon A (4 Weeks) | Corneal Coverage | Yes | 100.0 percentage of eyes |
| Samfilcon A (4 Weeks) | Corneal Coverage | No | 0.0 percentage of eyes |
| Samfilcon A (Day 26) | Corneal Coverage | Yes | 100.0 percentage of eyes |
| Samfilcon A (Day 26) | Corneal Coverage | No | 0.0 percentage of eyes |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens (Baseline) | Deterioration in Comfort | Yes=deterioration in comfort present | 47 participants |
| Habitual Lens (Baseline) | Deterioration in Comfort | No=deterioration in comfort absent | 43 participants |
| Comfilcon A (2 Weeks) | Deterioration in Comfort | Yes=deterioration in comfort present | 51 participants |
| Comfilcon A (2 Weeks) | Deterioration in Comfort | No=deterioration in comfort absent | 31 participants |
| Samfilcon A (2 Weeks) | Deterioration in Comfort | Yes=deterioration in comfort present | 46 participants |
| Samfilcon A (2 Weeks) | Deterioration in Comfort | No=deterioration in comfort absent | 36 participants |
| Comfilcon A (4 Weeks) | Deterioration in Comfort | No=deterioration in comfort absent | 29 participants |
| Comfilcon A (4 Weeks) | Deterioration in Comfort | Yes=deterioration in comfort present | 53 participants |
| Samfilcon A (4 Weeks) | Deterioration in Comfort | Yes=deterioration in comfort present | 52 participants |
| Samfilcon A (4 Weeks) | Deterioration in Comfort | No=deterioration in comfort absent | 28 participants |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lens (Baseline) | Dryness | During a typical day of wear | 8.06 units on a scale | Standard Deviation 2.24 |
| Habitual Lens (Baseline) | Dryness | Prior to removal | 7.57 units on a scale | Standard Deviation 2.26 |
| Comfilcon A (2 Weeks) | Dryness | During a typical day of wear | 7.98 units on a scale | Standard Deviation 1.91 |
| Comfilcon A (2 Weeks) | Dryness | Prior to removal | 7.61 units on a scale | Standard Deviation 2.12 |
| Samfilcon A (2 Weeks) | Dryness | During a typical day of wear | 7.46 units on a scale | Standard Deviation 2.12 |
| Samfilcon A (2 Weeks) | Dryness | Prior to removal | 6.83 units on a scale | Standard Deviation 2.49 |
| Comfilcon A (4 Weeks) | Dryness | Prior to removal | 7.27 units on a scale | Standard Deviation 2.49 |
| Comfilcon A (4 Weeks) | Dryness | During a typical day of wear | 7.71 units on a scale | Standard Deviation 2.13 |
| Samfilcon A (4 Weeks) | Dryness | During a typical day of wear | 7.18 units on a scale | Standard Deviation 2.22 |
| Samfilcon A (4 Weeks) | Dryness | Prior to removal | 6.60 units on a scale | Standard Deviation 2.44 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens (Baseline) | Film Deposits | 0.12 units on a scale | Standard Deviation 0.32 |
| Comfilcon A (2 Weeks) | Film Deposits | 0.26 units on a scale | Standard Deviation 0.63 |
| Samfilcon A (2 Weeks) | Film Deposits | 0.35 units on a scale | Standard Deviation 0.73 |
| Comfilcon A (4 Weeks) | Film Deposits | 0.30 units on a scale | Standard Deviation 0.63 |
Secondary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Habitual Lens (Baseline) | Lens Centration | Centered - optimal | 173 Eyes |
| Habitual Lens (Baseline) | Lens Centration | Decentered slightly | 1 Eyes |
| Habitual Lens (Baseline) | Lens Centration | Substantially decentered | 0 Eyes |
| Comfilcon A (2 Weeks) | Lens Centration | Centered - optimal | 153 Eyes |
| Comfilcon A (2 Weeks) | Lens Centration | Substantially decentered | 0 Eyes |
| Comfilcon A (2 Weeks) | Lens Centration | Decentered slightly | 16 Eyes |
| Samfilcon A (2 Weeks) | Lens Centration | Decentered slightly | 2 Eyes |
| Samfilcon A (2 Weeks) | Lens Centration | Substantially decentered | 0 Eyes |
| Samfilcon A (2 Weeks) | Lens Centration | Centered - optimal | 162 Eyes |
| Comfilcon A (4 Weeks) | Lens Centration | Centered - optimal | 152 Eyes |
| Comfilcon A (4 Weeks) | Lens Centration | Decentered slightly | 12 Eyes |
| Comfilcon A (4 Weeks) | Lens Centration | Substantially decentered | 0 Eyes |
| Samfilcon A (4 Weeks) | Lens Centration | Centered - optimal | 163 Eyes |
| Samfilcon A (4 Weeks) | Lens Centration | Substantially decentered | 0 Eyes |
| Samfilcon A (4 Weeks) | Lens Centration | Decentered slightly | 1 Eyes |
| Samfilcon A (Day 26) | Lens Centration | Centered - optimal | 156 Eyes |
| Samfilcon A (Day 26) | Lens Centration | Decentered slightly | 4 Eyes |
| Samfilcon A (Day 26) | Lens Centration | Substantially decentered | 0 Eyes |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens (Baseline) | Lens Surface Wetting | 3.69 units on a scale | Standard Deviation 0.51 |
| Comfilcon A (2 Weeks) | Lens Surface Wetting | 3.61 units on a scale | Standard Deviation 0.57 |
| Samfilcon A (2 Weeks) | Lens Surface Wetting | 3.51 units on a scale | Standard Deviation 0.56 |
| Comfilcon A (4 Weeks) | Lens Surface Wetting | 3.37 units on a scale | Standard Deviation 0.7 |
| Samfilcon A (4 Weeks) | Lens Surface Wetting | 3.27 units on a scale | Standard Deviation 0.85 |
| Samfilcon A (Day 26) | Lens Surface Wetting | 3.22 units on a scale | Standard Deviation 0.81 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens (Baseline) | Lens Tightness Push-up | 48.9 percentage of mean lens tightness | Standard Deviation 10.8 |
| Comfilcon A (2 Weeks) | Lens Tightness Push-up | 54.3 percentage of mean lens tightness | Standard Deviation 11.9 |
| Samfilcon A (2 Weeks) | Lens Tightness Push-up | 50.6 percentage of mean lens tightness | Standard Deviation 10.4 |
| Comfilcon A (4 Weeks) | Lens Tightness Push-up | 54.1 percentage of mean lens tightness | Standard Deviation 9.9 |
| Samfilcon A (4 Weeks) | Lens Tightness Push-up | 50.3 percentage of mean lens tightness | Standard Deviation 8.2 |
| Samfilcon A (Day 26) | Lens Tightness Push-up | 54.6 percentage of mean lens tightness | Standard Deviation 8.4 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens (Baseline) | Overall Fit Acceptance | 3.71 units on a scale | Standard Deviation 0.45 |
| Comfilcon A (2 Weeks) | Overall Fit Acceptance | 3.63 units on a scale | Standard Deviation 0.48 |
| Samfilcon A (2 Weeks) | Overall Fit Acceptance | 3.73 units on a scale | Standard Deviation 0.44 |
| Comfilcon A (4 Weeks) | Overall Fit Acceptance | 3.63 units on a scale | Standard Deviation 0.48 |
| Samfilcon A (4 Weeks) | Overall Fit Acceptance | 3.78 units on a scale | Standard Deviation 0.42 |
| Samfilcon A (Day 26) | Overall Fit Acceptance | 3.66 units on a scale | Standard Deviation 0.48 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lens (Baseline) | Overall Lens Handling | Ease of insertion | 9.31 units on a scale | Standard Deviation 1.4 |
| Habitual Lens (Baseline) | Overall Lens Handling | Ease of removal | 9.31 units on a scale | Standard Deviation 1.38 |
| Comfilcon A (2 Weeks) | Overall Lens Handling | Ease of insertion | 9.12 units on a scale | Standard Deviation 1.56 |
| Comfilcon A (2 Weeks) | Overall Lens Handling | Ease of removal | 8.94 units on a scale | Standard Deviation 1.84 |
| Samfilcon A (2 Weeks) | Overall Lens Handling | Ease of insertion | 8.96 units on a scale | Standard Deviation 1.69 |
| Samfilcon A (2 Weeks) | Overall Lens Handling | Ease of removal | 9.06 units on a scale | Standard Deviation 1.53 |
| Comfilcon A (4 Weeks) | Overall Lens Handling | Ease of removal | 8.86 units on a scale | Standard Deviation 2.14 |
| Comfilcon A (4 Weeks) | Overall Lens Handling | Ease of insertion | 9.18 units on a scale | Standard Deviation 1.48 |
| Samfilcon A (4 Weeks) | Overall Lens Handling | Ease of insertion | 8.83 units on a scale | Standard Deviation 1.73 |
| Samfilcon A (4 Weeks) | Overall Lens Handling | Ease of removal | 8.98 units on a scale | Standard Deviation 1.48 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens (Baseline) | Post-Blink Movement | 1.91 units on a scale | Standard Deviation 0.55 |
| Comfilcon A (2 Weeks) | Post-Blink Movement | 1.86 units on a scale | Standard Deviation 0.58 |
| Samfilcon A (2 Weeks) | Post-Blink Movement | 1.84 units on a scale | Standard Deviation 0.51 |
| Comfilcon A (4 Weeks) | Post-Blink Movement | 1.79 units on a scale | Standard Deviation 0.58 |
| Samfilcon A (4 Weeks) | Post-Blink Movement | 1.87 units on a scale | Standard Deviation 0.42 |
| Samfilcon A (Day 26) | Post-Blink Movement | 1.69 units on a scale | Standard Deviation 0.5 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens (Baseline) | Primary Gaze Lag | 1.89 units on a scale | Standard Deviation 0.55 |
| Comfilcon A (2 Weeks) | Primary Gaze Lag | 1.82 units on a scale | Standard Deviation 0.63 |
| Samfilcon A (2 Weeks) | Primary Gaze Lag | 1.78 units on a scale | Standard Deviation 0.54 |
| Comfilcon A (4 Weeks) | Primary Gaze Lag | 1.69 units on a scale | Standard Deviation 0.56 |
| Samfilcon A (4 Weeks) | Primary Gaze Lag | 1.88 units on a scale | Standard Deviation 0.48 |
| Samfilcon A (Day 26) | Primary Gaze Lag | 1.71 units on a scale | Standard Deviation 0.54 |
Secondary
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
Population: Number of participants analyzed differ from participant flow due to protocol deviations.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens (Baseline) | Vision Quality | 9.31 units on a scale | Standard Deviation 1.1 |
| Comfilcon A (2 Weeks) | Vision Quality | 9.06 units on a scale | Standard Deviation 1.15 |
| Samfilcon A (2 Weeks) | Vision Quality | 8.49 units on a scale | Standard Deviation 1.81 |
| Comfilcon A (4 Weeks) | Vision Quality | 8.81 units on a scale | Standard Deviation 1.55 |
| Samfilcon A (4 Weeks) | Vision Quality | 8.34 units on a scale | Standard Deviation 1.79 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lens (Baseline) | Visual Acuity (VA) | Distance Visual Acuity | -0.03 LogMAR | Standard Deviation 0.08 |
| Habitual Lens (Baseline) | Visual Acuity (VA) | Binocular Distance Visual Acuity | -0.07 LogMAR | Standard Deviation 0.09 |
| Comfilcon A (2 Weeks) | Visual Acuity (VA) | Distance Visual Acuity | -0.04 LogMAR | Standard Deviation 0.1 |
| Comfilcon A (2 Weeks) | Visual Acuity (VA) | Binocular Distance Visual Acuity | -0.08 LogMAR | Standard Deviation 0.1 |
| Samfilcon A (2 Weeks) | Visual Acuity (VA) | Distance Visual Acuity | -0.01 LogMAR | Standard Deviation 0.1 |
| Samfilcon A (2 Weeks) | Visual Acuity (VA) | Binocular Distance Visual Acuity | -0.07 LogMAR | Standard Deviation 0.09 |
| Comfilcon A (4 Weeks) | Visual Acuity (VA) | Binocular Distance Visual Acuity | -0.08 LogMAR | Standard Deviation 0.1 |
| Comfilcon A (4 Weeks) | Visual Acuity (VA) | Distance Visual Acuity | -0.03 LogMAR | Standard Deviation 0.1 |
| Samfilcon A (4 Weeks) | Visual Acuity (VA) | Distance Visual Acuity | -0.02 LogMAR | Standard Deviation 0.12 |
| Samfilcon A (4 Weeks) | Visual Acuity (VA) | Binocular Distance Visual Acuity | -0.07 LogMAR | Standard Deviation 0.1 |
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Habitual Lens (Baseline) | Wearing Times | Average wearing time | 6.16 hours | Standard Deviation 1.37 |
| Habitual Lens (Baseline) | Wearing Times | Maximum wearing time | 16.59 hours | Standard Deviation 2.9 |
| Habitual Lens (Baseline) | Wearing Times | Comfortable wearing time | 12.79 hours | Standard Deviation 2.64 |
| Comfilcon A (2 Weeks) | Wearing Times | Maximum wearing time | 16.15 hours | Standard Deviation 2.39 |
| Comfilcon A (2 Weeks) | Wearing Times | Comfortable wearing time | 11.58 hours | Standard Deviation 3.05 |
| Comfilcon A (2 Weeks) | Wearing Times | Average wearing time | 13.94 hours | Standard Deviation 1.82 |
| Samfilcon A (2 Weeks) | Wearing Times | Maximum wearing time | 15.48 hours | Standard Deviation 2.48 |
| Samfilcon A (2 Weeks) | Wearing Times | Comfortable wearing time | 11.28 hours | Standard Deviation 3.84 |
| Samfilcon A (2 Weeks) | Wearing Times | Average wearing time | 13.68 hours | Standard Deviation 2.46 |
| Comfilcon A (4 Weeks) | Wearing Times | Comfortable wearing time | 11.34 hours | Standard Deviation 3.48 |
| Comfilcon A (4 Weeks) | Wearing Times | Average wearing time | 13.90 hours | Standard Deviation 2.18 |
| Comfilcon A (4 Weeks) | Wearing Times | Maximum wearing time | 16.04 hours | Standard Deviation 2.44 |
| Samfilcon A (4 Weeks) | Wearing Times | Average wearing time | 13.93 hours | Standard Deviation 2.11 |
| Samfilcon A (4 Weeks) | Wearing Times | Maximum wearing time | 15.91 hours | Standard Deviation 2.35 |
| Samfilcon A (4 Weeks) | Wearing Times | Comfortable wearing time | 11.02 hours | Standard Deviation 3.63 |
Secondary
White Spot Deposits
Number of white spot deposits for comfilcon A and samfilcon A lenses.
Time frame: 2 weeks and 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Habitual Lens (Baseline) | White Spot Deposits | 0.3 number of white spots | Standard Deviation 1 |
| Comfilcon A (2 Weeks) | White Spot Deposits | 0.4 number of white spots | Standard Deviation 1.4 |
| Samfilcon A (2 Weeks) | White Spot Deposits | 0.8 number of white spots | Standard Deviation 2.6 |
| Comfilcon A (4 Weeks) | White Spot Deposits | 0.7 number of white spots | Standard Deviation 2.4 |