Myopia
Conditions
Brief summary
This double-masked, randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses.
Detailed description
This double-masked (subject and investigator), randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable test contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses. After a month of re-useable lens wear in the comfilcon A lenses, subjects were randomized to wear each daily disposable lens type for one week.
Interventions
DEVICEcomfilcon A
Contact Lens
DEVICEsomofilcon A
daily disposable contact lens
DEVICEstenfilcon A
daily disposable contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Subjects and investigators will be masked to the study lenses - lenses will be overlabelled.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Subjects will only be eligible for the study if: * They are between 18 and 40 years of age (inclusive). * They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent. * They are willing and able to follow the protocol. * They are an existing soft reusable spherical contact lens wearer in both eyes. * They have a contact lens spherical prescription between -0.50 to -6.00D (inclusive) based on the ocular refraction. * They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction * They own a wearable pair of spectacles and wear them on the day of the initial visit. * They have distance high contrast logMAR visual acuity of 0.2 or better in each eye with their habitual spectacles. * They agree not to participate in other clinical research for the duration of the study.
Exclusion criteria
* They have an ocular disorder which would normally contra-indicate contact lens wear. * They have a systemic disorder which would normally contra-indicate contact lens wear. * They are using any topical medication such as eye drops or ointment. * They are aphakic. * They have had corneal refractive surgery. * They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. * They are pregnant or breastfeeding. * They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction. * They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use | 4 weeks | Subjective Scores of comfort at Insertion after 4 weeks of Comfilcon A use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). |
| Subjective Scores of Comfort on Insertion | 1 week | Subjective Scores of Comfort on Insertion rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use | 4 weeks | Subjective Scores on Comfort before removal after 4 weeks of comfilcon use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). |
| Subjective Scores on Comfort Before Removal | 1 week | Subjective Scores on Comfort before removal rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). |
| Number of Participants With Horizontal Lens Centration Grade | Baseline (after 5 minutes of lens dispense) | Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal) |
| Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear | 4 weeks | Number of Participants with Horizontal lens centration after 4 weeks of comfilcon A wear graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal) |
| Number of Participants With Vertical Lens Centration Grade | Baseline (After 5 minutes of lens dispense) | Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior) |
| Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear | 4 weeks | Number of Participants with Vertical lens centration after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior) |
| Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use | 4 weeks | Subjective scores on overall comfort after 4 weeks of comfilcon use rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). |
| Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear | 4 weeks | Number of Participants with Lens Corneal coverage after 4 weeks of comfilcon A wear graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) |
| Number of Participants With Post-Blink Movement Grade | Baseline (after 5 minutes of lens dispense) | Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) |
| Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear | 4 weeks | Number of Participants with Post-blink movement after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) |
| Investigator Lens Fit Acceptance | Baseline (after 5 minutes of lens dispense) | Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree) |
| Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use | 4 weeks | Lens fit acceptance investigator rating for comfilcon A after 4 weeks of use for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree) |
| Number of Participants With Lens Corneal Coverage Grade | Baseline (after 5 minutes of lens dispense) | Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive) |
| Subjective Scores on Overall Comfort | 1 week | Subjective Scores on overall comfort rated on a scale 0 - 100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt). |
Countries
United Kingdom
Participant flow
Pre-assignment details
All subjects were fitted with comfilcon A for one month and then the subjects were randomized to wear two daily disposable lenses for one week.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Subjects were randomized to wear comfilcon A lens on a daily wear, reusable basis for 1 month, then fitted and wear the somofilcon A daily disposable test lens and stenfilcon A daily disposable test lens each for 1 week of daily wear.
comfilcon A: Contact Lens
somofilcon A: daily disposable contact lens
stenfilcon A: daily disposable contact lens | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Withdrawal by Subject | 1 | 1 |
| Second Intervention | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 55 Participants | — |
| Age, Continuous | 26.1 years STANDARD_DEVIATION 5.7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 55 participants | — |
| Sex: Female, Male Female | 51 Participants | — |
| Sex: Female, Male Male | 4 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 53 | 0 / 53 |
| other Total, other adverse events | 0 / 55 | 0 / 53 | 0 / 53 |
| serious Total, serious adverse events | 0 / 55 | 0 / 53 | 0 / 53 |
Outcome results
Primary
Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use
Subjective Scores of comfort at Insertion after 4 weeks of Comfilcon A use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time frame: 4 weeks
Population: One subject discontinued after dispensing visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use | 89.9 units on a scale | Standard Deviation 14.5 |
Primary
Subjective Scores of Comfort on Insertion
Subjective Scores of Comfort on Insertion rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Subjective Scores of Comfort on Insertion | 90.3 units on a scale | Standard Deviation 12.6 |
| Stenfilcon A Contact Lens | Subjective Scores of Comfort on Insertion | 90.4 units on a scale | Standard Deviation 12.8 |
Secondary
Investigator Lens Fit Acceptance
Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)
Time frame: Baseline (after 5 minutes of lens dispense)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Investigator Lens Fit Acceptance | Acceptable Fits | 100 percentage of lenses |
| Comfilcon A | Investigator Lens Fit Acceptance | Optimum Fits | 27 percentage of lenses |
| Stenfilcon A Contact Lens | Investigator Lens Fit Acceptance | Acceptable Fits | 100 percentage of lenses |
| Stenfilcon A Contact Lens | Investigator Lens Fit Acceptance | Optimum Fits | 16 percentage of lenses |
| Stenfilcon A Contact Lens | Investigator Lens Fit Acceptance | Acceptable Fits | 100 percentage of lenses |
| Stenfilcon A Contact Lens | Investigator Lens Fit Acceptance | Optimum Fits | 28 percentage of lenses |
Secondary
Investigator Lens Fit Acceptance
Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Investigator Lens Fit Acceptance | Acceptable Fits | 100 percentage of lenses |
| Comfilcon A | Investigator Lens Fit Acceptance | Optimum Fits | 10 percentage of lenses |
| Stenfilcon A Contact Lens | Investigator Lens Fit Acceptance | Acceptable Fits | 100 percentage of lenses |
| Stenfilcon A Contact Lens | Investigator Lens Fit Acceptance | Optimum Fits | 21 percentage of lenses |
Secondary
Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use
Lens fit acceptance investigator rating for comfilcon A after 4 weeks of use for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)
Time frame: 4 weeks
Population: One subject discontinued after dispensing visit
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Comfilcon A | Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use | Acceptable Fits | 98 percentage of lenses |
| Comfilcon A | Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use | Optimum Fits | 33 percentage of lenses |
Secondary
Number of Participants With Horizontal Lens Centration Grade
Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)
Time frame: 1 week
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comfilcon A | Number of Participants With Horizontal Lens Centration Grade | Optimum | 20 Participants |
| Comfilcon A | Number of Participants With Horizontal Lens Centration Grade | Slightly nasal | 3 Participants |
| Comfilcon A | Number of Participants With Horizontal Lens Centration Grade | Slightly Temporal | 28 Participants |
| Comfilcon A | Number of Participants With Horizontal Lens Centration Grade | Extremely Temporal | 0 Participants |
| Comfilcon A | Number of Participants With Horizontal Lens Centration Grade | Extremely nasal | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Horizontal Lens Centration Grade | Extremely Temporal | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Horizontal Lens Centration Grade | Extremely nasal | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Horizontal Lens Centration Grade | Slightly nasal | 1 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Horizontal Lens Centration Grade | Optimum | 30 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Horizontal Lens Centration Grade | Slightly Temporal | 21 Participants |
Secondary
Number of Participants With Horizontal Lens Centration Grade
Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)
Time frame: Baseline (after 5 minutes of lens dispense)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comfilcon A | Number of Participants With Horizontal Lens Centration Grade | Slightly Temporal | 20 Participants |
| Comfilcon A | Number of Participants With Horizontal Lens Centration Grade | Optimum | 35 Participants |
| Comfilcon A | Number of Participants With Horizontal Lens Centration Grade | Extremely nasal | 0 Participants |
| Comfilcon A | Number of Participants With Horizontal Lens Centration Grade | Slightly nasal | 0 Participants |
| Comfilcon A | Number of Participants With Horizontal Lens Centration Grade | Extremely Temporal | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Horizontal Lens Centration Grade | Optimum | 19 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Horizontal Lens Centration Grade | Extremely nasal | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Horizontal Lens Centration Grade | Slightly nasal | 2 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Horizontal Lens Centration Grade | Slightly Temporal | 30 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Horizontal Lens Centration Grade | Extremely Temporal | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Horizontal Lens Centration Grade | Extremely Temporal | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Horizontal Lens Centration Grade | Slightly Temporal | 18 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Horizontal Lens Centration Grade | Extremely nasal | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Horizontal Lens Centration Grade | Optimum | 33 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Horizontal Lens Centration Grade | Slightly nasal | 2 Participants |
Secondary
Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Number of Participants with Horizontal lens centration after 4 weeks of comfilcon A wear graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)
Time frame: 4 weeks
Population: One subject discontinued after dispensing visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comfilcon A | Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear | Extremely nasal | 0 Participants |
| Comfilcon A | Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear | Slightly nasal | 1 Participants |
| Comfilcon A | Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear | Optimum | 32 Participants |
| Comfilcon A | Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear | Slightly Temporal | 21 Participants |
| Comfilcon A | Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear | Extremely Temporal | 0 Participants |
Secondary
Number of Participants With Lens Corneal Coverage Grade
Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Time frame: Baseline (after 5 minutes of lens dispense)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comfilcon A | Number of Participants With Lens Corneal Coverage Grade | Slightly excessive | 4 Participants |
| Comfilcon A | Number of Participants With Lens Corneal Coverage Grade | Optimum | 48 Participants |
| Comfilcon A | Number of Participants With Lens Corneal Coverage Grade | Extremely Inadequate | 0 Participants |
| Comfilcon A | Number of Participants With Lens Corneal Coverage Grade | Slightly inadequate | 3 Participants |
| Comfilcon A | Number of Participants With Lens Corneal Coverage Grade | Extremely excessive | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Lens Corneal Coverage Grade | Optimum | 26 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Lens Corneal Coverage Grade | Extremely Inadequate | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Lens Corneal Coverage Grade | Slightly inadequate | 23 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Lens Corneal Coverage Grade | Slightly excessive | 2 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Lens Corneal Coverage Grade | Extremely excessive | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Lens Corneal Coverage Grade | Extremely excessive | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Lens Corneal Coverage Grade | Slightly excessive | 6 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Lens Corneal Coverage Grade | Extremely Inadequate | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Lens Corneal Coverage Grade | Optimum | 46 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Lens Corneal Coverage Grade | Slightly inadequate | 1 Participants |
Secondary
Number of Participants With Lens Corneal Coverage Grade
Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Time frame: 1 week
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comfilcon A | Number of Participants With Lens Corneal Coverage Grade | Slightly inadequate | 20 Participants |
| Comfilcon A | Number of Participants With Lens Corneal Coverage Grade | Slightly excessive | 1 Participants |
| Comfilcon A | Number of Participants With Lens Corneal Coverage Grade | Optimum | 30 Participants |
| Comfilcon A | Number of Participants With Lens Corneal Coverage Grade | Extremely excessive | 0 Participants |
| Comfilcon A | Number of Participants With Lens Corneal Coverage Grade | Extremely Inadequate | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Lens Corneal Coverage Grade | Extremely excessive | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Lens Corneal Coverage Grade | Extremely Inadequate | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Lens Corneal Coverage Grade | Slightly inadequate | 3 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Lens Corneal Coverage Grade | Optimum | 43 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Lens Corneal Coverage Grade | Slightly excessive | 6 Participants |
Secondary
Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear
Number of Participants with Lens Corneal coverage after 4 weeks of comfilcon A wear graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Time frame: 4 weeks
Population: One subject discontinued after dispensing Visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comfilcon A | Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear | Extremely Inadequate | 0 Participants |
| Comfilcon A | Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear | Slightly inadequate | 4 Participants |
| Comfilcon A | Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear | Optimum | 43 Participants |
| Comfilcon A | Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear | Slightly excessive | 6 Participants |
| Comfilcon A | Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear | Extremely excessive | 1 Participants |
Secondary
Number of Participants With Post-Blink Movement Grade
Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Time frame: 1 week
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comfilcon A | Number of Participants With Post-Blink Movement Grade | Slightly inadequate | 5 Participants |
| Comfilcon A | Number of Participants With Post-Blink Movement Grade | Slightly excessive | 12 Participants |
| Comfilcon A | Number of Participants With Post-Blink Movement Grade | Optimum | 34 Participants |
| Comfilcon A | Number of Participants With Post-Blink Movement Grade | Extremely excessive | 0 Participants |
| Comfilcon A | Number of Participants With Post-Blink Movement Grade | Extremely inadequate | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Post-Blink Movement Grade | Extremely excessive | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Post-Blink Movement Grade | Extremely inadequate | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Post-Blink Movement Grade | Slightly inadequate | 5 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Post-Blink Movement Grade | Optimum | 28 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Post-Blink Movement Grade | Slightly excessive | 19 Participants |
Secondary
Number of Participants With Post-Blink Movement Grade
Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Time frame: Baseline (after 5 minutes of lens dispense)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comfilcon A | Number of Participants With Post-Blink Movement Grade | Slightly excessive | 9 Participants |
| Comfilcon A | Number of Participants With Post-Blink Movement Grade | Optimum | 35 Participants |
| Comfilcon A | Number of Participants With Post-Blink Movement Grade | Extremely inadequate | 0 Participants |
| Comfilcon A | Number of Participants With Post-Blink Movement Grade | Slightly inadequate | 11 Participants |
| Comfilcon A | Number of Participants With Post-Blink Movement Grade | Extremely excessive | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Post-Blink Movement Grade | Optimum | 33 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Post-Blink Movement Grade | Extremely inadequate | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Post-Blink Movement Grade | Slightly inadequate | 6 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Post-Blink Movement Grade | Slightly excessive | 12 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Post-Blink Movement Grade | Extremely excessive | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Post-Blink Movement Grade | Extremely excessive | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Post-Blink Movement Grade | Slightly excessive | 15 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Post-Blink Movement Grade | Extremely inadequate | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Post-Blink Movement Grade | Optimum | 31 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Post-Blink Movement Grade | Slightly inadequate | 7 Participants |
Secondary
Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear
Number of Participants with Post-blink movement after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)
Time frame: 4 weeks
Population: One subject discontinued after dispensing visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comfilcon A | Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear | Extremely inadequate | 0 Participants |
| Comfilcon A | Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear | Slightly inadequate | 6 Participants |
| Comfilcon A | Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear | Optimum | 38 Participants |
| Comfilcon A | Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear | Slightly excessive | 10 Participants |
| Comfilcon A | Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear | Extremely excessive | 0 Participants |
Secondary
Number of Participants With Vertical Lens Centration Grade
Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)
Time frame: Baseline (After 5 minutes of lens dispense)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comfilcon A | Number of Participants With Vertical Lens Centration Grade | Slightly Superior | 8 Participants |
| Comfilcon A | Number of Participants With Vertical Lens Centration Grade | Optimum | 35 Participants |
| Comfilcon A | Number of Participants With Vertical Lens Centration Grade | Extremely Inferior | 0 Participants |
| Comfilcon A | Number of Participants With Vertical Lens Centration Grade | Slightly Inferior | 12 Participants |
| Comfilcon A | Number of Participants With Vertical Lens Centration Grade | Extremely Superior | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Vertical Lens Centration Grade | Optimum | 23 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Vertical Lens Centration Grade | Extremely Inferior | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Vertical Lens Centration Grade | Slightly Inferior | 8 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Vertical Lens Centration Grade | Slightly Superior | 20 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Vertical Lens Centration Grade | Extremely Superior | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Vertical Lens Centration Grade | Extremely Superior | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Vertical Lens Centration Grade | Slightly Superior | 11 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Vertical Lens Centration Grade | Extremely Inferior | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Vertical Lens Centration Grade | Optimum | 35 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Vertical Lens Centration Grade | Slightly Inferior | 7 Participants |
Secondary
Number of Participants With Vertical Lens Centration Grade
Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)
Time frame: 1 week
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comfilcon A | Number of Participants With Vertical Lens Centration Grade | Slightly Inferior | 10 Participants |
| Comfilcon A | Number of Participants With Vertical Lens Centration Grade | Slightly Superior | 19 Participants |
| Comfilcon A | Number of Participants With Vertical Lens Centration Grade | Optimum | 22 Participants |
| Comfilcon A | Number of Participants With Vertical Lens Centration Grade | Extremely Superior | 0 Participants |
| Comfilcon A | Number of Participants With Vertical Lens Centration Grade | Extremely Inferior | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Vertical Lens Centration Grade | Extremely Superior | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Vertical Lens Centration Grade | Extremely Inferior | 0 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Vertical Lens Centration Grade | Slightly Inferior | 4 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Vertical Lens Centration Grade | Optimum | 37 Participants |
| Stenfilcon A Contact Lens | Number of Participants With Vertical Lens Centration Grade | Slightly Superior | 11 Participants |
Secondary
Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear
Number of Participants with Vertical lens centration after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)
Time frame: 4 weeks
Population: One subject discontinued after dispensing visit
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Comfilcon A | Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear | Extremely Inferior | 0 Participants |
| Comfilcon A | Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear | Slightly Inferior | 9 Participants |
| Comfilcon A | Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear | Optimum | 38 Participants |
| Comfilcon A | Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear | Slightly Superior | 7 Participants |
| Comfilcon A | Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear | Extremely Superior | 0 Participants |
Secondary
Subjective Scores on Comfort Before Removal
Subjective Scores on Comfort before removal rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Subjective Scores on Comfort Before Removal | 77.6 units on a scale | Standard Deviation 19 |
| Stenfilcon A Contact Lens | Subjective Scores on Comfort Before Removal | 79.3 units on a scale | Standard Deviation 15.8 |
Secondary
Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use
Subjective Scores on Comfort before removal after 4 weeks of comfilcon use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time frame: 4 weeks
Population: One Subject discontinued after dispensing visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use | 73.1 units on a scale | Standard Deviation 20.2 |
Secondary
Subjective Scores on Overall Comfort
Subjective Scores on overall comfort rated on a scale 0 - 100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Subjective Scores on Overall Comfort | 84.0 units on a scale | Standard Deviation 16.8 |
| Stenfilcon A Contact Lens | Subjective Scores on Overall Comfort | 85.7 units on a scale | Standard Deviation 13.2 |
Secondary
Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use
Subjective scores on overall comfort after 4 weeks of comfilcon use rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).
Time frame: 4 weeks
Population: One Subject discontinued after dispensing visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Comfilcon A | Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use | 83.7 units on a scale | Standard Deviation 15.5 |