Ametropia
Conditions
Brief summary
This subject-masked, randomized, bilateral crossover study will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis.
Detailed description
This will be a randomized, subject-masked, crossover, bilateral study, controlled by cross-comparison. This will compare the clinical performance and subjective acceptance of the somofilcon A 1 day soft contact lens with the nelfilcon A daily disposable lens when used on a daily wear, daily disposable basis. Subjects will use each lens type for a week in random sequence. Follow-up visits for each lens will be performed after one week of wear. Lenses will be worn on a daily wear, daily disposable wear schedule.
Interventions
DEVICEsomofilcon A
Contact Lens
DEVICEnelfilcon A
Contact Lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Intervention model description
This is a bilateral crossover study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* They are of legal age (18) and capacity to volunteer. * 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 agree not to participate in other clinical research for the duration of this study. * They have a contact lens spherical prescription between -1.00 to - 6.00D (inclusive) * They have a maximum of -1.00DC ocular astigmatism in each eye. * They can be satisfactorily fitted with the study lens types. * At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range. * They currently use soft contact lenses or have done so in the previous six months. * They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day). * They own a wearable pair of spectacles.
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 have had cataract surgery. * 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 breast-feeding. * They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. * 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. * They currently wear either the clariti 1day or the DAILIES AquaComfort Plus lens.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Comfort at Lens Dispensing | Baseline (after 5 minutes of lens dispense) | Subjective comfort at lens dispensing on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.). |
| Subjective Comfort at Start of Day | 1 week | Subjective comfort at start of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.). |
| Subjective Comfort at End of Day | 1 week | Subjective comfort at end of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.). |
| Overall Subjective Comfort | Baseline (after 5 minutes of lens dispense) | Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.). |
| Subjective Vision | Baseline (after 5 minutes of lens dispense) | Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Horizontal Centration - Lens Fit | Baseline (after 5 minutes of lens dispense) | Horizontal centration graded by -2 to 2 (-2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal). |
| Vertical Centration Grade - Lens Fit | Baseline (after 5 minutes of lens dispense) | Vertical centration graded by -2 to 2 (-2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior). |
| Biomicroscopy - Conjunctival Redness Score | One Week | Conjunctival redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). |
| Post-Blink Movement Grade | Baseline (after 5 minutes of lens dispense) | Post-blink movement graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive). |
| Ocular Redness Rating | 1 week | Ocular redness rating rated on a scale 0-100 (0=extremely poor, intolerable levels of redness to 100 = excellent, no redness) |
| Corneal Coverage Grade | Baseline (after 5 minutes of lens dispense) | Corneal coverage graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive). |
| Biomicroscopy - Limbal Redness Score | One week | Limbal redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). |
| Biomicroscopy - Corneal Staining Score | One week | Corneal staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). |
| Biomicroscopy - Conjunctival Staining Score | One week | Conjunctival staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). |
| Biomicroscopy - Papillary Conjunctivitis Score | One week | Papillary conjunctivitis- slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe). |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Subjects were randomized to wear somofilcon A 1 day and nelfilcon A for one week in this cross-over study. | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Withdrawal by Subject | 0 | 1 |
| Second Intervention | Adverse Event | 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 | 70 Participants | — |
| Age, Continuous | 31.6 years STANDARD_DEVIATION 10 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United Kingdom | 70 participants | — |
| Sex: Female, Male Female | 55 Participants | — |
| Sex: Female, Male Male | 15 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 70 | 0 / 70 |
| other Total, other adverse events | 2 / 70 | 0 / 70 |
| serious Total, serious adverse events | 0 / 70 | 0 / 70 |
Outcome results
Primary
Overall Subjective Comfort
Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Time frame: Baseline (after 5 minutes of lens dispense)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Overall Subjective Comfort | 90.4 units on a scale | Standard Deviation 10.1 |
| Nelfilcon A | Overall Subjective Comfort | 90.9 units on a scale | Standard Deviation 10.8 |
Primary
Overall Subjective Comfort
Overall subjective comfort on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Overall Subjective Comfort | 86.1 units on a scale | Standard Deviation 14.1 |
| Nelfilcon A | Overall Subjective Comfort | 78.8 units on a scale | Standard Deviation 19.8 |
Primary
Subjective Comfort at End of Day
Subjective comfort at end of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Subjective Comfort at End of Day | 75.9 units on a scale | Standard Deviation 22.1 |
| Nelfilcon A | Subjective Comfort at End of Day | 68.0 units on a scale | Standard Deviation 25.5 |
Primary
Subjective Comfort at Lens Dispensing
Subjective comfort at lens dispensing on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Time frame: Baseline (after 5 minutes of lens dispense)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Subjective Comfort at Lens Dispensing | 90.9 units on a scale | Standard Deviation 11.6 |
| Nelfilcon A | Subjective Comfort at Lens Dispensing | 88.5 units on a scale | Standard Deviation 12.8 |
Primary
Subjective Comfort at Start of Day
Subjective comfort at start of day on scale 0-100 (0=Causes pain. Cannot be tolerated to 100=Excellent. Cannot be felt.).
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Subjective Comfort at Start of Day | 89.9 units on a scale | Standard Deviation 13.8 |
| Nelfilcon A | Subjective Comfort at Start of Day | 87.0 units on a scale | Standard Deviation 14.7 |
Primary
Subjective Vision
Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)
Time frame: Baseline (after 5 minutes of lens dispense)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Subjective Vision | 92.8 units on a scale | Standard Deviation 10.1 |
| Nelfilcon A | Subjective Vision | 94.2 units on a scale | Standard Deviation 7.8 |
Primary
Subjective Vision
Subjective Vision rated on scale 0-100 (0=unacceptable, lens cannot be worn to 100=excellent, unaware of an visual loss.)
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Subjective Vision | 90.9 units on a scale | Standard Deviation 12.1 |
| Nelfilcon A | Subjective Vision | 92.1 units on a scale | Standard Deviation 13.2 |
Secondary
Biomicroscopy - Conjunctival Redness Score
Conjunctival redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
Time frame: One Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Biomicroscopy - Conjunctival Redness Score | 0.85 units on a scale | Standard Deviation 0.25 |
| Nelfilcon A | Biomicroscopy - Conjunctival Redness Score | 0.87 units on a scale | Standard Deviation 0.25 |
Secondary
Biomicroscopy - Conjunctival Staining Score
Conjunctival staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
Time frame: One week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Biomicroscopy - Conjunctival Staining Score | 1.46 units on a scale | Standard Deviation 0.71 |
| Nelfilcon A | Biomicroscopy - Conjunctival Staining Score | 0.35 units on a scale | Standard Deviation 0.36 |
Secondary
Biomicroscopy - Corneal Staining Score
Corneal staining - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
Time frame: One week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Biomicroscopy - Corneal Staining Score | 0.33 units on a scale | Standard Deviation 0.43 |
| Nelfilcon A | Biomicroscopy - Corneal Staining Score | 0.32 units on a scale | Standard Deviation 0.4 |
Secondary
Biomicroscopy - Limbal Redness Score
Limbal redness - slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
Time frame: One week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Biomicroscopy - Limbal Redness Score | 0.74 units on a scale | Standard Deviation 0.27 |
| Nelfilcon A | Biomicroscopy - Limbal Redness Score | 0.79 units on a scale | Standard Deviation 0.28 |
Secondary
Biomicroscopy - Papillary Conjunctivitis Score
Papillary conjunctivitis- slit lamp biomicroscopy using Efron Grading Scale, 0 - 4 (0=normal, 1=trace, 2=mild, 3=moderate, 4=severe).
Time frame: One week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Biomicroscopy - Papillary Conjunctivitis Score | 1.02 units on a scale | Standard Deviation 0.2 |
| Nelfilcon A | Biomicroscopy - Papillary Conjunctivitis Score | 1.03 units on a scale | Standard Deviation 0.18 |
Secondary
Corneal Coverage Grade
Corneal coverage graded by -2 to 2 (-2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive).
Time frame: One week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somofilcon A | Corneal Coverage Grade | Slightly inadequate | 36 percentage of lenses |
| Somofilcon A | Corneal Coverage Grade | Slightly excessive | 0 percentage of lenses |
| Somofilcon A | Corneal Coverage Grade | Optimum | 64 percentage of lenses |
| Somofilcon A | Corneal Coverage Grade | Extremely excessive | 0 percentage of lenses |
| Somofilcon A | Corneal Coverage Grade | Extremely inadequate | 0 percentage of lenses |
| Nelfilcon A | Corneal Coverage Grade | Extremely excessive | 0 percentage of lenses |
| Nelfilcon A | Corneal Coverage Grade | Extremely inadequate | 1 percentage of lenses |
| Nelfilcon A | Corneal Coverage Grade | Slightly inadequate | 26 percentage of lenses |
| Nelfilcon A | Corneal Coverage Grade | Optimum | 71 percentage of lenses |
| Nelfilcon A | Corneal Coverage Grade | Slightly excessive | 1 percentage of lenses |
Secondary
Corneal Coverage Grade
Corneal coverage graded by -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 (NUMBER) |
|---|---|---|---|
| Somofilcon A | Corneal Coverage Grade | Extremely excessive | 0 percentage of lenses |
| Somofilcon A | Corneal Coverage Grade | Extremely inadequate | 1 percentage of lenses |
| Somofilcon A | Corneal Coverage Grade | Slightly inadequate | 28 percentage of lenses |
| Somofilcon A | Corneal Coverage Grade | Optimum | 71 percentage of lenses |
| Somofilcon A | Corneal Coverage Grade | Slightly excessive | 0 percentage of lenses |
| Nelfilcon A | Corneal Coverage Grade | Slightly excessive | 3 percentage of lenses |
| Nelfilcon A | Corneal Coverage Grade | Optimum | 74 percentage of lenses |
| Nelfilcon A | Corneal Coverage Grade | Extremely inadequate | 0 percentage of lenses |
| Nelfilcon A | Corneal Coverage Grade | Extremely excessive | 0 percentage of lenses |
| Nelfilcon A | Corneal Coverage Grade | Slightly inadequate | 23 percentage of lenses |
Secondary
Horizontal Centration - Lens Fit
Horizontal centration graded by -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 (NUMBER) |
|---|---|---|---|
| Somofilcon A | Horizontal Centration - Lens Fit | Slightly nasal | 6 percentage of lenses |
| Somofilcon A | Horizontal Centration - Lens Fit | Slightly temporal | 43 percentage of lenses |
| Somofilcon A | Horizontal Centration - Lens Fit | Optimum | 51 percentage of lenses |
| Somofilcon A | Horizontal Centration - Lens Fit | Extremely temporal | 0 percentage of lenses |
| Somofilcon A | Horizontal Centration - Lens Fit | Extremely nasal | 0 percentage of lenses |
| Nelfilcon A | Horizontal Centration - Lens Fit | Extremely temporal | 0 percentage of lenses |
| Nelfilcon A | Horizontal Centration - Lens Fit | Extremely nasal | 0 percentage of lenses |
| Nelfilcon A | Horizontal Centration - Lens Fit | Slightly nasal | 6 percentage of lenses |
| Nelfilcon A | Horizontal Centration - Lens Fit | Optimum | 63 percentage of lenses |
| Nelfilcon A | Horizontal Centration - Lens Fit | Slightly temporal | 31 percentage of lenses |
Secondary
Horizontal Centration - Lens Fit
Horizontal centration graded by -2 to 2 (-2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal).
Time frame: One Week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somofilcon A | Horizontal Centration - Lens Fit | Slightly nasal | 3 percentage of lenses |
| Somofilcon A | Horizontal Centration - Lens Fit | Slightly temporal | 56 percentage of lenses |
| Somofilcon A | Horizontal Centration - Lens Fit | Optimum | 41 percentage of lenses |
| Somofilcon A | Horizontal Centration - Lens Fit | Extremely temporal | 0 percentage of lenses |
| Somofilcon A | Horizontal Centration - Lens Fit | Extremely nasal | 0 percentage of lenses |
| Nelfilcon A | Horizontal Centration - Lens Fit | Extremely temporal | 0 percentage of lenses |
| Nelfilcon A | Horizontal Centration - Lens Fit | Extremely nasal | 0 percentage of lenses |
| Nelfilcon A | Horizontal Centration - Lens Fit | Slightly nasal | 1 percentage of lenses |
| Nelfilcon A | Horizontal Centration - Lens Fit | Optimum | 57 percentage of lenses |
| Nelfilcon A | Horizontal Centration - Lens Fit | Slightly temporal | 41 percentage of lenses |
Secondary
Ocular Redness Rating
Ocular redness rating rated on a scale 0-100 (0=extremely poor, intolerable levels of redness to 100 = excellent, no redness)
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A | Ocular Redness Rating | 94.1 units on a scale | Standard Deviation 8.9 |
| Nelfilcon A | Ocular Redness Rating | 92.8 units on a scale | Standard Deviation 12.7 |
Secondary
Post-Blink Movement Grade
Post-blink movement graded by -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 (NUMBER) |
|---|---|---|---|
| Somofilcon A | Post-Blink Movement Grade | Slightly inadequate | 17 percentage of lenses |
| Somofilcon A | Post-Blink Movement Grade | Slightly Excessive | 16 percentage of lenses |
| Somofilcon A | Post-Blink Movement Grade | Optimum | 65 percentage of lenses |
| Somofilcon A | Post-Blink Movement Grade | Extremely Excessive | 1 percentage of lenses |
| Somofilcon A | Post-Blink Movement Grade | Extremely inadequate | 0 percentage of lenses |
| Nelfilcon A | Post-Blink Movement Grade | Extremely Excessive | 0 percentage of lenses |
| Nelfilcon A | Post-Blink Movement Grade | Extremely inadequate | 0 percentage of lenses |
| Nelfilcon A | Post-Blink Movement Grade | Slightly inadequate | 19 percentage of lenses |
| Nelfilcon A | Post-Blink Movement Grade | Optimum | 57 percentage of lenses |
| Nelfilcon A | Post-Blink Movement Grade | Slightly Excessive | 24 percentage of lenses |
Secondary
Post-Blink Movement Grade
Post-blink movement graded by -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 (NUMBER) |
|---|---|---|---|
| Somofilcon A | Post-Blink Movement Grade | Slightly inadequate | 21 percentage of lenses |
| Somofilcon A | Post-Blink Movement Grade | Slightly Excessive | 12 percentage of lenses |
| Somofilcon A | Post-Blink Movement Grade | Optimum | 67 percentage of lenses |
| Somofilcon A | Post-Blink Movement Grade | Extremely Excessive | 0 percentage of lenses |
| Somofilcon A | Post-Blink Movement Grade | Extremely inadequate | 0 percentage of lenses |
| Nelfilcon A | Post-Blink Movement Grade | Extremely Excessive | 1 percentage of lenses |
| Nelfilcon A | Post-Blink Movement Grade | Extremely inadequate | 0 percentage of lenses |
| Nelfilcon A | Post-Blink Movement Grade | Slightly inadequate | 26 percentage of lenses |
| Nelfilcon A | Post-Blink Movement Grade | Optimum | 46 percentage of lenses |
| Nelfilcon A | Post-Blink Movement Grade | Slightly Excessive | 26 percentage of lenses |
Secondary
Vertical Centration Grade - Lens Fit
Vertical centration graded by -2 to 2 (-2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior).
Time frame: One week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Somofilcon A | Vertical Centration Grade - Lens Fit | Slightly inferior | 23 percentage of lenses |
| Somofilcon A | Vertical Centration Grade - Lens Fit | Slightly superior | 33 percentage of lenses |
| Somofilcon A | Vertical Centration Grade - Lens Fit | Optimum | 44 percentage of lenses |
| Somofilcon A | Vertical Centration Grade - Lens Fit | Extremely superior | 0 percentage of lenses |
| Somofilcon A | Vertical Centration Grade - Lens Fit | Extremely inferior | 0 percentage of lenses |
| Nelfilcon A | Vertical Centration Grade - Lens Fit | Extremely superior | 0 percentage of lenses |
| Nelfilcon A | Vertical Centration Grade - Lens Fit | Extremely inferior | 0 percentage of lenses |
| Nelfilcon A | Vertical Centration Grade - Lens Fit | Slightly inferior | 50 percentage of lenses |
| Nelfilcon A | Vertical Centration Grade - Lens Fit | Optimum | 44 percentage of lenses |
| Nelfilcon A | Vertical Centration Grade - Lens Fit | Slightly superior | 6 percentage of lenses |
Secondary
Vertical Centration Grade - Lens Fit
Vertical centration graded by -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 (NUMBER) |
|---|---|---|---|
| Somofilcon A | Vertical Centration Grade - Lens Fit | Slightly inferior | 17 percentage of lenses |
| Somofilcon A | Vertical Centration Grade - Lens Fit | Slightly superior | 32 percentage of lenses |
| Somofilcon A | Vertical Centration Grade - Lens Fit | Optimum | 49 percentage of lenses |
| Somofilcon A | Vertical Centration Grade - Lens Fit | Extremely superior | 0 percentage of lenses |
| Somofilcon A | Vertical Centration Grade - Lens Fit | Extremely inferior | 1 percentage of lenses |
| Nelfilcon A | Vertical Centration Grade - Lens Fit | Extremely superior | 0 percentage of lenses |
| Nelfilcon A | Vertical Centration Grade - Lens Fit | Extremely inferior | 0 percentage of lenses |
| Nelfilcon A | Vertical Centration Grade - Lens Fit | Slightly inferior | 43 percentage of lenses |
| Nelfilcon A | Vertical Centration Grade - Lens Fit | Optimum | 49 percentage of lenses |
| Nelfilcon A | Vertical Centration Grade - Lens Fit | Slightly superior | 9 percentage of lenses |