Myopia
Conditions
Brief summary
The purpose of this study is to investigate the overall clinical performance of the test daily disposable stenfilcon A lens with solution additive (test) compared to the stenfilcon A lens (control).
Detailed description
This will be, prospective, multicenter, double-masked, randomized, bilateral, 1 month cross-over, dispensing study comparing the test lens against the stenfilcon A control lens with a study duration of approximately two months. Each subject will be randomized to wear either the test or control as a matched pair first and subjects will be randomized based on the order in which the subject is enrolled and qualified into the study.
Interventions
DEVICEstenfilcon A lens with solution additive (test)
silicone hydrogel lens
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* A person is eligible for inclusion in the study if he/she: * Has had a self-reported oculo-visual examination in the last two years. * Is at least 18 years of age and has full legal capacity to volunteer. * Has read and understood the information consent letter. * Is willing and able to follow instructions and maintain the appointment schedule. * Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected. * Must achieve 20/30 or better (in each eye) with study lenses * Requires spectacle lens powers between -0.75 and -6.50 diopters sphere (0.25D steps). * Has no more than 0.75 diopters of refractive astigmatism. * Currently wears soft contact lenses. * Have clear corneas and no active ocular disease. * Has not worn lenses for at least 12 hours before the examination
Exclusion criteria
* A person will be excluded from the study if he/she: * Has never worn contact lenses before. * Has any systemic disease affecting ocular health. * Is using any systemic or topical medications that will affect ocular health. * Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. * Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. * Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * Is aphakic. * Has undergone corneal refractive surgery. * Is pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit). * Have taken part in any other contact lens or care solution clinical trial or research, within one week prior to starting this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Limbal Hyperemia | 1 Week | Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection) |
| Visual Acuity On High Illumination High Contrast | Baseline | Visual acuity is assessed on high illumination high contrast logMAR charts for test and control lenses. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart. |
| Visual Acuity On Low Illumination High Contrast | Baseline | Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart. |
| Overall Corneal Staining | One Week | Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe. |
| Conjunctival Staining | 1 Week | Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent |
| Bulbar Hyperemia | 1 Week | Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection) |
| Palpebral Hyperemia | 1 Week | Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection) |
| Subjective Ratings on Comfort | Baseline | Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable |
| Vision Satisfaction | Baseline | Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lens Fit Acceptance | Baseline | Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum. |
| Handling Satisfaction | 1 week | Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree |
| Lens Surface - Deposits | Baseline | Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface. |
| Subjective Ratings on Dryness | Baseline | Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry |
| Lens Surface - Wettability | Baseline | Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Total Participants | 72 |
| Total | 72 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First Intervention | Adverse Event | 1 | 0 |
| Second Intervention | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 72 Participants | — |
| Age, Continuous | 28 years STANDARD_DEVIATION 7 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 72 participants | — |
| Sex: Female, Male Female | 59 Participants | — |
| Sex: Female, Male Male | 13 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 72 |
| other Total, other adverse events | 1 / 72 | 5 / 72 |
| serious Total, serious adverse events | 0 / 72 | 0 / 72 |
Outcome results
Primary
Bulbar Hyperemia
Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Time frame: 1 Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Bulbar Hyperemia | 1.32 units on a scale | Standard Deviation 0.85 |
| Stenfilcon A Lens (Control) | Bulbar Hyperemia | 1.28 units on a scale | Standard Deviation 0.78 |
Primary
Bulbar Hyperemia
Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Bulbar Hyperemia | 1.36 units on a scale | Standard Deviation 0.81 |
| Stenfilcon A Lens (Control) | Bulbar Hyperemia | 1.33 units on a scale | Standard Deviation 0.82 |
Primary
Conjunctival Staining
Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Conjunctival Staining | 0.42 units on a scale | Standard Deviation 0.37 |
| Stenfilcon A Lens (Control) | Conjunctival Staining | 0.45 units on a scale | Standard Deviation 0.43 |
Primary
Conjunctival Staining
Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent
Time frame: 1 Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Conjunctival Staining | 0.36 units on a scale | Standard Deviation 0.45 |
| Stenfilcon A Lens (Control) | Conjunctival Staining | 0.39 units on a scale | Standard Deviation 0.43 |
Primary
Limbal Hyperemia
Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Limbal Hyperemia | 0.90 units on a scale | Standard Deviation 0.66 |
| Stenfilcon A Lens (Control) | Limbal Hyperemia | 0.78 units on a scale | Standard Deviation 0.67 |
Primary
Limbal Hyperemia
Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Time frame: 1 Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Limbal Hyperemia | 0.85 units on a scale | Standard Deviation 0.64 |
| Stenfilcon A Lens (Control) | Limbal Hyperemia | 0.89 units on a scale | Standard Deviation 0.68 |
Primary
Overall Corneal Staining
Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.
Time frame: One Month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Overall Corneal Staining | Garde 1 | 33 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Overall Corneal Staining | Grade 3 | 0 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Overall Corneal Staining | Grade 2 | 13 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Overall Corneal Staining | Grade 4 | 0 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Overall Corneal Staining | Grade 0 | 54 percentage of participants |
| Stenfilcon A Lens (Control) | Overall Corneal Staining | Grade 4 | 0 percentage of participants |
| Stenfilcon A Lens (Control) | Overall Corneal Staining | Grade 0 | 58 percentage of participants |
| Stenfilcon A Lens (Control) | Overall Corneal Staining | Garde 1 | 30 percentage of participants |
| Stenfilcon A Lens (Control) | Overall Corneal Staining | Grade 2 | 11 percentage of participants |
| Stenfilcon A Lens (Control) | Overall Corneal Staining | Grade 3 | 1 percentage of participants |
Primary
Overall Corneal Staining
Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.
Time frame: One Week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Overall Corneal Staining | Grade 2 | 14 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Overall Corneal Staining | Grade 0 | 55 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Overall Corneal Staining | Grade 3 | 0 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Overall Corneal Staining | Grade 4 | 0 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Overall Corneal Staining | Garde 1 | 31 percentage of participants |
| Stenfilcon A Lens (Control) | Overall Corneal Staining | Grade 4 | 0 percentage of participants |
| Stenfilcon A Lens (Control) | Overall Corneal Staining | Garde 1 | 27 percentage of participants |
| Stenfilcon A Lens (Control) | Overall Corneal Staining | Grade 2 | 14 percentage of participants |
| Stenfilcon A Lens (Control) | Overall Corneal Staining | Grade 3 | 2 percentage of participants |
| Stenfilcon A Lens (Control) | Overall Corneal Staining | Grade 0 | 57 percentage of participants |
Primary
Palpebral Hyperemia
Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Time frame: 1 Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Palpebral Hyperemia | 0.89 units on a scale | Standard Deviation 0.65 |
| Stenfilcon A Lens (Control) | Palpebral Hyperemia | 0.88 units on a scale | Standard Deviation 0.63 |
Primary
Palpebral Hyperemia
Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Palpebral Hyperemia | 1.02 units on a scale | Standard Deviation 0.63 |
| Stenfilcon A Lens (Control) | Palpebral Hyperemia | 0.93 units on a scale | Standard Deviation 0.55 |
Primary
Subjective Ratings on Comfort
Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Subjective Ratings on Comfort | 9.7 units on a scale | Standard Deviation 0.6 |
| Stenfilcon A Lens (Control) | Subjective Ratings on Comfort | 9.6 units on a scale | Standard Deviation 0.7 |
Primary
Subjective Ratings on Comfort
Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Subjective Ratings on Comfort | 8.9 units on a scale | Standard Deviation 1.7 |
| Stenfilcon A Lens (Control) | Subjective Ratings on Comfort | 8.6 units on a scale | Standard Deviation 1.9 |
Primary
Subjective Ratings on Comfort
Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable
Time frame: 1 Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Subjective Ratings on Comfort | 9.1 units on a scale | Standard Deviation 1.5 |
| Stenfilcon A Lens (Control) | Subjective Ratings on Comfort | 9.0 units on a scale | Standard Deviation 1.5 |
Primary
Vision Satisfaction
Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Vision Satisfaction | Disagree | 0 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Vision Satisfaction | Agree | 39 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Vision Satisfaction | Neutral | 6 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Vision Satisfaction | Strongly agree | 55 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Vision Satisfaction | Strongly disagree | 0 percentage of participants |
| Stenfilcon A Lens (Control) | Vision Satisfaction | Strongly agree | 60 percentage of participants |
| Stenfilcon A Lens (Control) | Vision Satisfaction | Strongly disagree | 0 percentage of participants |
| Stenfilcon A Lens (Control) | Vision Satisfaction | Disagree | 0 percentage of participants |
| Stenfilcon A Lens (Control) | Vision Satisfaction | Neutral | 1 percentage of participants |
| Stenfilcon A Lens (Control) | Vision Satisfaction | Agree | 39 percentage of participants |
Primary
Vision Satisfaction
Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Time frame: 1 Month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Vision Satisfaction | Disagree | 1 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Vision Satisfaction | Agree | 34 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Vision Satisfaction | Neutral | 4 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Vision Satisfaction | Strongly agree | 58 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Vision Satisfaction | Strongly disagree | 3 percentage of participants |
| Stenfilcon A Lens (Control) | Vision Satisfaction | Strongly agree | 61 percentage of participants |
| Stenfilcon A Lens (Control) | Vision Satisfaction | Strongly disagree | 1 percentage of participants |
| Stenfilcon A Lens (Control) | Vision Satisfaction | Disagree | 3 percentage of participants |
| Stenfilcon A Lens (Control) | Vision Satisfaction | Neutral | 9 percentage of participants |
| Stenfilcon A Lens (Control) | Vision Satisfaction | Agree | 26 percentage of participants |
Primary
Vision Satisfaction
Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Vision Satisfaction | Neutral | 3 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Vision Satisfaction | Strongly agree | 65 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Vision Satisfaction | Agree | 29 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Vision Satisfaction | Strongly disagree | 0 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Vision Satisfaction | Disagree | 3 percentage of participants |
| Stenfilcon A Lens (Control) | Vision Satisfaction | Strongly disagree | 1 percentage of participants |
| Stenfilcon A Lens (Control) | Vision Satisfaction | Disagree | 1 percentage of participants |
| Stenfilcon A Lens (Control) | Vision Satisfaction | Neutral | 4 percentage of participants |
| Stenfilcon A Lens (Control) | Vision Satisfaction | Agree | 26 percentage of participants |
| Stenfilcon A Lens (Control) | Vision Satisfaction | Strongly agree | 68 percentage of participants |
Primary
Visual Acuity On High Illumination High Contrast
Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Visual Acuity On High Illumination High Contrast | -0.21 LogMAR | Standard Deviation 0.07 |
| Stenfilcon A Lens (Control) | Visual Acuity On High Illumination High Contrast | -0.20 LogMAR | Standard Deviation 0.05 |
Primary
Visual Acuity On High Illumination High Contrast
Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Time frame: 1 Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Visual Acuity On High Illumination High Contrast | -0.21 LogMAR | Standard Deviation 0.06 |
| Stenfilcon A Lens (Control) | Visual Acuity On High Illumination High Contrast | -0.20 LogMAR | Standard Deviation 0.06 |
Primary
Visual Acuity On High Illumination High Contrast
Visual acuity is assessed on high illumination high contrast logMAR charts for test and control lenses. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Visual Acuity On High Illumination High Contrast | -0.20 LogMAR | Standard Deviation 0.06 |
| Stenfilcon A Lens (Control) | Visual Acuity On High Illumination High Contrast | -0.21 LogMAR | Standard Deviation 0.06 |
Primary
Visual Acuity On Low Illumination High Contrast
Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Visual Acuity On Low Illumination High Contrast | -0.09 LogMAR | Standard Deviation 0.1 |
| Stenfilcon A Lens (Control) | Visual Acuity On Low Illumination High Contrast | -0.09 LogMAR | Standard Deviation 0.09 |
Primary
Visual Acuity On Low Illumination High Contrast
Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Time frame: 1 Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Visual Acuity On Low Illumination High Contrast | -0.09 LogMAR | Standard Deviation 0.1 |
| Stenfilcon A Lens (Control) | Visual Acuity On Low Illumination High Contrast | -0.09 LogMAR | Standard Deviation 0.09 |
Primary
Visual Acuity On Low Illumination High Contrast
Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Visual Acuity On Low Illumination High Contrast | -0.08 LogMAR | Standard Deviation 0.09 |
| Stenfilcon A Lens (Control) | Visual Acuity On Low Illumination High Contrast | -0.09 LogMAR | Standard Deviation 0.09 |
Secondary
Handling Satisfaction
Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Handling Satisfaction | Disagree | 0 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Handling Satisfaction | Agree | 25 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Handling Satisfaction | Neutral | 3 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Handling Satisfaction | Strongly Agree | 72 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Handling Satisfaction | Strongly disagree | 0 percentage of participants |
| Stenfilcon A Lens (Control) | Handling Satisfaction | Strongly Agree | 75 percentage of participants |
| Stenfilcon A Lens (Control) | Handling Satisfaction | Strongly disagree | 0 percentage of participants |
| Stenfilcon A Lens (Control) | Handling Satisfaction | Disagree | 1 percentage of participants |
| Stenfilcon A Lens (Control) | Handling Satisfaction | Neutral | 1 percentage of participants |
| Stenfilcon A Lens (Control) | Handling Satisfaction | Agree | 23 percentage of participants |
Secondary
Handling Satisfaction
Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree
Time frame: 1 Month
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Handling Satisfaction | Disagree | 0 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Handling Satisfaction | Agree | 30 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Handling Satisfaction | Neutral | 1 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Handling Satisfaction | Strongly Agree | 69 percentage of participants |
| Stenfilcon A Lens With Solution Additive (Test) | Handling Satisfaction | Strongly disagree | 0 percentage of participants |
| Stenfilcon A Lens (Control) | Handling Satisfaction | Strongly Agree | 72 percentage of participants |
| Stenfilcon A Lens (Control) | Handling Satisfaction | Strongly disagree | 1 percentage of participants |
| Stenfilcon A Lens (Control) | Handling Satisfaction | Disagree | 4 percentage of participants |
| Stenfilcon A Lens (Control) | Handling Satisfaction | Neutral | 0 percentage of participants |
| Stenfilcon A Lens (Control) | Handling Satisfaction | Agree | 23 percentage of participants |
Secondary
Lens Fit Acceptance
Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Lens Fit Acceptance | 3.4 units on a scale | Standard Deviation 0.3 |
| Stenfilcon A Lens (Control) | Lens Fit Acceptance | 3.3 units on a scale | Standard Deviation 0.3 |
Secondary
Lens Fit Acceptance
Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Lens Fit Acceptance | 3.3 units on a scale | Standard Deviation 0.3 |
| Stenfilcon A Lens (Control) | Lens Fit Acceptance | 3.2 units on a scale | Standard Deviation 0.5 |
Secondary
Lens Fit Acceptance
Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Lens Fit Acceptance | 3.3 units on a scale | Standard Deviation 0.3 |
| Stenfilcon A Lens (Control) | Lens Fit Acceptance | 3.3 units on a scale | Standard Deviation 0.3 |
Secondary
Lens Surface - Deposits
Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Lens Surface - Deposits | 0.03 units on a scale | Standard Deviation 0.15 |
| Stenfilcon A Lens (Control) | Lens Surface - Deposits | 0.02 units on a scale | Standard Deviation 0.15 |
Secondary
Lens Surface - Deposits
Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Lens Surface - Deposits | 0.06 units on a scale | Standard Deviation 0.27 |
| Stenfilcon A Lens (Control) | Lens Surface - Deposits | 0.02 units on a scale | Standard Deviation 0.15 |
Secondary
Lens Surface - Deposits
Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Lens Surface - Deposits | 0.04 units on a scale | Standard Deviation 0.2 |
| Stenfilcon A Lens (Control) | Lens Surface - Deposits | 0.04 units on a scale | Standard Deviation 0.19 |
Secondary
Lens Surface - Wettability
Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
Time frame: 1 Week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Lens Surface - Wettability | 3.47 units on a scale | Standard Deviation 0.46 |
| Stenfilcon A Lens (Control) | Lens Surface - Wettability | 3.33 units on a scale | Standard Deviation 0.48 |
Secondary
Lens Surface - Wettability
Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Lens Surface - Wettability | 3.52 units on a scale | Standard Deviation 0.36 |
| Stenfilcon A Lens (Control) | Lens Surface - Wettability | 3.52 units on a scale | Standard Deviation 0.35 |
Secondary
Lens Surface - Wettability
Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Lens Surface - Wettability | 3.37 units on a scale | Standard Deviation 0.43 |
| Stenfilcon A Lens (Control) | Lens Surface - Wettability | 3.38 units on a scale | Standard Deviation 0.44 |
Secondary
Subjective Ratings on Dryness
Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Subjective Ratings on Dryness | 9.6 units on a scale | Standard Deviation 1.3 |
| Stenfilcon A Lens (Control) | Subjective Ratings on Dryness | 9.5 units on a scale | Standard Deviation 0.9 |
Secondary
Subjective Ratings on Dryness
Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Subjective Ratings on Dryness | 8.8 units on a scale | Standard Deviation 1.8 |
| Stenfilcon A Lens (Control) | Subjective Ratings on Dryness | 8.8 units on a scale | Standard Deviation 1.6 |
Secondary
Subjective Ratings on Dryness
Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry
Time frame: 1 Month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stenfilcon A Lens With Solution Additive (Test) | Subjective Ratings on Dryness | 8.3 units on a scale | Standard Deviation 2.1 |
| Stenfilcon A Lens (Control) | Subjective Ratings on Dryness | 8.1 units on a scale | Standard Deviation 2.3 |