Myopia
Conditions
Brief summary
Evaluation of two contact lenses
Detailed description
One week dispensing, investigator-masked, randomized, contralateral study comparing the test lens against the control lens. Each subject will be randomized to wear the test lens in one eye and the control lens in the other eye simultaneously.
Interventions
DEVICEEtafilcon A
DEVICEStenfilcon A
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
17 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is at least 17 years of age and has full legal capacity to volunteer; * Has read and signed an information consent letter; * Is willing and able to follow instructions and maintain the appointment schedule; * Is correctable to a visual acuity of 20/30 or better (in each eye) with their habitual correction and the assigned study lenses; * Has astigmatism less than or equal to -1.00D; * Is an adapted soft contact lens wearer; * Demonstrates an acceptable fit with the study lenses; * Has no active anterior segment disease or known ocular disease.
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, neovascularization, corneal scars or corneal opacities; * Is aphakic; * Has undergone corneal refractive surgery; * Is participating in any other type of clinical or research study; * Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant's Subjective Rating of Overall Preference (Questionnaire) | 12-hours, 1-week | Participants rated their overall lens preference by questionnaire. (annotated scale, 0-100, scale normalized to 0=no preference, +50=strongly prefers test lens, -50=strongly prefers control lens). Change over time measured at 12-hours, 1-week |
| Participant's Subjective Rating of Comfort (Questionnaire) | Insertion, After Lens settling, 12-hours, 1-week | Participants rated their comfort of lenses by subjective questionnaire (un-annotated scale, 0-100, 0=Poor comfort/intolerable, 100=Excellent comfort/cannot be felt) Change over time measured at insertion, After settling, 12-hours, 1-week |
| Participant's Subjective Rating of Dryness (Questionnaire) | 12-hours, 1-week | Participants rated dryness of the lenses by subjective questionnaire (annotated scale, 0-100, 0=cannot be worn / extremely dry, 100=no dryness experienced at any time) Change over time measured at 12-hours, 1-week |
| Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire) | Dispense | Participants rated their lens handling experience for lens insertion by questionnaire (un-annotated scale, 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye) Measured at Dispensing |
| Participant's Subjective Rating of Lens Handling for Removal (Questionnaire) | 12-hours, 1-week | Participants rated their lens handling experience for the lens removal by questionnaire (un-annotated scale, 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye) Change over time measured at 12-hours, 1-week |
| Participant's Subjective Rating of Visual Quality (Questionnaire) | 12-hours, 1-week | Participants rated visual quality of the lenses by questionnaire (annotated scale, 0-100, 0=extremely poor vision all of the time. Cannot function, 100=excellent vision all of the time) Change over time measured at 12-hours, 1-week |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy) | Insertion, 12 hours, 1 week | Investigators assigned a lens surface wettability grade by biomicroscopy assessment (grading scale, 0 to 4, 0=excellent, 4=severely reduced). Change over time measured after lens settling (insertion), after 12-hours wear on the dispense day (12-hours), after a minimum on one hour of lens wear at 1 week (1-week). |
| Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy) | Insertion, 12 hours, 1 week | Investigators assigned an overall fit acceptance grade by biomicroscopy assessment (grading scale, 0-4, 0=very poor, 4=very good). Change over time measured at insertion, 12-hours, 1-week |
| Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen) | Insertion | Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at normal lighting conditions (high illumination). (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week. |
| Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen) | Insertion, 12-hours, 1-week | Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at low lighting conditions (low illumination). (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week. |
| Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | Baseline, 12-hours, 1-week | Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with corneal staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week |
| Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | Baseline, 12-hours, 1-week | Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with conjuncitval staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week |
Countries
Canada
Participant flow
Pre-assignment details
Two participants were determined to be ineligible at the screening visit due to their level of astigmatism
Participants by arm
| Arm | Count |
|---|---|
| All Participants Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously
Etafilcon A
Stenfilcon A | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants |
| Age, Continuous | 26.9 years STANDARD_DEVIATION 9.5 |
| Region of Enrollment Canada | 44 participants |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 |
Outcome results
Primary
Participant's Subjective Rating of Comfort (Questionnaire)
Participants rated their comfort of lenses by subjective questionnaire (un-annotated scale, 0-100, 0=Poor comfort/intolerable, 100=Excellent comfort/cannot be felt) Change over time measured at insertion, After settling, 12-hours, 1-week
Time frame: Insertion, After Lens settling, 12-hours, 1-week
Population: One participant temporarily discontinued from study after 12-hour visit. (n=43 at 1-week visit)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Participant's Subjective Rating of Comfort (Questionnaire) | Insertion | 92 units on a scale | Standard Deviation 11 |
| Etafilcon A | Participant's Subjective Rating of Comfort (Questionnaire) | After settling | 96 units on a scale | Standard Deviation 7 |
| Etafilcon A | Participant's Subjective Rating of Comfort (Questionnaire) | 12-hours | 91 units on a scale | Standard Deviation 12 |
| Etafilcon A | Participant's Subjective Rating of Comfort (Questionnaire) | 1-week | 90 units on a scale | Standard Deviation 10 |
| Stenfilcon A | Participant's Subjective Rating of Comfort (Questionnaire) | 1-week | 90 units on a scale | Standard Deviation 10 |
| Stenfilcon A | Participant's Subjective Rating of Comfort (Questionnaire) | Insertion | 91 units on a scale | Standard Deviation 11 |
| Stenfilcon A | Participant's Subjective Rating of Comfort (Questionnaire) | 12-hours | 88 units on a scale | Standard Deviation 13 |
| Stenfilcon A | Participant's Subjective Rating of Comfort (Questionnaire) | After settling | 93 units on a scale | Standard Deviation 10 |
Primary
Participant's Subjective Rating of Dryness (Questionnaire)
Participants rated dryness of the lenses by subjective questionnaire (annotated scale, 0-100, 0=cannot be worn / extremely dry, 100=no dryness experienced at any time) Change over time measured at 12-hours, 1-week
Time frame: 12-hours, 1-week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Participant's Subjective Rating of Dryness (Questionnaire) | 12-hours | 86 units on a scale | Standard Deviation 17 |
| Etafilcon A | Participant's Subjective Rating of Dryness (Questionnaire) | 1-week | 83 units on a scale | Standard Deviation 20 |
| Stenfilcon A | Participant's Subjective Rating of Dryness (Questionnaire) | 12-hours | 83 units on a scale | Standard Deviation 21 |
| Stenfilcon A | Participant's Subjective Rating of Dryness (Questionnaire) | 1-week | 82 units on a scale | Standard Deviation 21 |
Primary
Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire)
Participants rated their lens handling experience for lens insertion by questionnaire (un-annotated scale, 0-100, 0=could not place lens on eye, 100=always easy to place lens on eye) Measured at Dispensing
Time frame: Dispense
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Etafilcon A | Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire) | 80 score on a scale | Standard Deviation 19 |
| Stenfilcon A | Participant's Subjective Rating of Lens Handling for Insertion (Questionnaire) | 86 score on a scale | Standard Deviation 14 |
Primary
Participant's Subjective Rating of Lens Handling for Removal (Questionnaire)
Participants rated their lens handling experience for the lens removal by questionnaire (un-annotated scale, 0-100, 0=could not remove lens from eye, 100=always easy to remove lens from eye) Change over time measured at 12-hours, 1-week
Time frame: 12-hours, 1-week
Population: One participant temporarily discontinued from study after 12-hour visit. (n=43 at 1-week visit)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Participant's Subjective Rating of Lens Handling for Removal (Questionnaire) | 12-hours | 97 units on a scale | Standard Deviation 7 |
| Etafilcon A | Participant's Subjective Rating of Lens Handling for Removal (Questionnaire) | 1-week | 94 units on a scale | Standard Deviation 12 |
| Stenfilcon A | Participant's Subjective Rating of Lens Handling for Removal (Questionnaire) | 12-hours | 92 units on a scale | Standard Deviation 15 |
| Stenfilcon A | Participant's Subjective Rating of Lens Handling for Removal (Questionnaire) | 1-week | 94 units on a scale | Standard Deviation 9 |
Primary
Participant's Subjective Rating of Overall Preference (Questionnaire)
Participants rated their overall lens preference by questionnaire. (annotated scale, 0-100, scale normalized to 0=no preference, +50=strongly prefers test lens, -50=strongly prefers control lens). Change over time measured at 12-hours, 1-week
Time frame: 12-hours, 1-week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Participant's Subjective Rating of Overall Preference (Questionnaire) | 12-hours | -8 score on a scale | Standard Deviation 24 |
| Etafilcon A | Participant's Subjective Rating of Overall Preference (Questionnaire) | 1-week | 5 score on a scale | Standard Deviation 16 |
Primary
Participant's Subjective Rating of Visual Quality (Questionnaire)
Participants rated visual quality of the lenses by questionnaire (annotated scale, 0-100, 0=extremely poor vision all of the time. Cannot function, 100=excellent vision all of the time) Change over time measured at 12-hours, 1-week
Time frame: 12-hours, 1-week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Participant's Subjective Rating of Visual Quality (Questionnaire) | 12-hours | 92 units on a scale | Standard Deviation 13 |
| Etafilcon A | Participant's Subjective Rating of Visual Quality (Questionnaire) | 1-week | 89 units on a scale | Standard Deviation 12 |
| Stenfilcon A | Participant's Subjective Rating of Visual Quality (Questionnaire) | 12-hours | 89 units on a scale | Standard Deviation 15 |
| Stenfilcon A | Participant's Subjective Rating of Visual Quality (Questionnaire) | 1-week | 89 units on a scale | Standard Deviation 14 |
Secondary
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy)
Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with conjuncitval staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week
Time frame: Baseline, 12-hours, 1-week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | baseline Temporal | 0.15 units on a scale | Standard Deviation 0.25 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | 12-hours Superior | 0.17 units on a scale | Standard Deviation 0.24 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | baseline Inferior | 0.09 units on a scale | Standard Deviation 0.29 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | 12-hours Inferior | 0.63 units on a scale | Standard Deviation 0.74 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | baseline Nasal | 0.23 units on a scale | Standard Deviation 0.035 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | 1-week Nasal | 0.83 units on a scale | Standard Deviation 0.62 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | 12-hours Nasal | 0.86 units on a scale | Standard Deviation 0.73 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | 1-week Temporal | 0.34 units on a scale | Standard Deviation 0.41 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | baseline Superior | 0.06 units on a scale | Standard Deviation 0.19 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | 1-week Superior | 0.17 units on a scale | Standard Deviation 0.3 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | 12-hours Temporal | 0.55 units on a scale | Standard Deviation 0.55 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | 1-week Inferior | 0.65 units on a scale | Standard Deviation 0.85 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | 12-hours Temporal | 0.93 units on a scale | Standard Deviation 0.59 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | baseline Nasal | 0.21 units on a scale | Standard Deviation 0.38 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | baseline Temporal | 0.11 units on a scale | Standard Deviation 0.21 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | baseline Superior | 0.06 units on a scale | Standard Deviation 0.19 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | baseline Inferior | 0.08 units on a scale | Standard Deviation 0.26 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | 12-hours Nasal | 0.72 units on a scale | Standard Deviation 0.57 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | 1-week Inferior | 0.50 units on a scale | Standard Deviation 0.66 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | 12-hours Superior | 0.59 units on a scale | Standard Deviation 0.73 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | 12-hours Inferior | 0.76 units on a scale | Standard Deviation 0.68 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | 1-week Nasal | 0.52 units on a scale | Standard Deviation 0.56 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | 1-week Temporal | 0.55 units on a scale | Standard Deviation 0.57 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Conjunctiva (Biomicroscopy) | 1-week Superior | 0.33 units on a scale | Standard Deviation 0.44 |
Secondary
Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy)
Investigators assigned an anterior ocular physiological response grade by biomicroscopy assessment with corneal staining (grading scale, 0-4, 0=none, 4=severe) Change over time measured at baseline (screening and dispensing visit), 12-hours, 1-week
Time frame: Baseline, 12-hours, 1-week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | baseline Inferior | 0.70 units on a scale | Standard Deviation 0.97 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 12-hours Superior | 0.23 units on a scale | Standard Deviation 0.45 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | baseline Nasal | 0.47 units on a scale | Standard Deviation 0.67 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 12-hours Inferior | 0.68 units on a scale | Standard Deviation 0.89 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 12-hours Central | 0.08 units on a scale | Standard Deviation 0.26 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 1-week Central | 0.10 units on a scale | Standard Deviation 0.35 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | baseline Superior | 0.30 units on a scale | Standard Deviation 0.6 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 1-week Nasal | 0.23 units on a scale | Standard Deviation 0.51 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 12-hours Nasal | 0.09 units on a scale | Standard Deviation 0.31 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 1-week Temporal | 0.22 units on a scale | Standard Deviation 0.51 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | baseline Temporal | 0.23 units on a scale | Standard Deviation 0.61 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 1-week Superior | 0.17 units on a scale | Standard Deviation 0.44 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 12-hours Temporal | 0.24 units on a scale | Standard Deviation 0.61 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 1-week Inferior | 0.69 units on a scale | Standard Deviation 0.74 |
| Etafilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | baseline Central | 0.08 units on a scale | Standard Deviation 0.28 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 1-week Inferior | 0.51 units on a scale | Standard Deviation 0.82 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | baseline Central | 0.23 units on a scale | Standard Deviation 0.48 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | baseline Nasal | 0.56 units on a scale | Standard Deviation 0.74 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | baseline Temporal | 0.14 units on a scale | Standard Deviation 0.38 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | baseline Superior | 0.25 units on a scale | Standard Deviation 0.51 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | baseline Inferior | 0.55 units on a scale | Standard Deviation 0.7 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 12-hours Central | 0.16 units on a scale | Standard Deviation 0.44 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 12-hours Nasal | 0.32 units on a scale | Standard Deviation 0.66 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 12-hours Temporal | 0.16 units on a scale | Standard Deviation 0.4 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 12-hours Superior | 0.32 units on a scale | Standard Deviation 0.51 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 12-hours Inferior | 0.74 units on a scale | Standard Deviation 0.87 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 1-week Central | 0.12 units on a scale | Standard Deviation 0.39 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 1-week Nasal | 0.24 units on a scale | Standard Deviation 0.48 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 1-week Temporal | 0.16 units on a scale | Standard Deviation 0.41 |
| Stenfilcon A | Investigator's Objective Assessment of Anterior Ocular Physiological Response, Cornea (Biomicroscopy) | 1-week Superior | 0.23 units on a scale | Standard Deviation 0.54 |
Secondary
Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy)
Investigators assigned a lens surface wettability grade by biomicroscopy assessment (grading scale, 0 to 4, 0=excellent, 4=severely reduced). Change over time measured after lens settling (insertion), after 12-hours wear on the dispense day (12-hours), after a minimum on one hour of lens wear at 1 week (1-week).
Time frame: Insertion, 12 hours, 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy) | Insertion | 0.69 units on a scale | Standard Deviation 0.82 |
| Etafilcon A | Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy) | 12-hours | 1.51 units on a scale | Standard Deviation 1.26 |
| Etafilcon A | Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy) | 1-week | 1.06 units on a scale | Standard Deviation 1 |
| Stenfilcon A | Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy) | Insertion | 0.78 units on a scale | Standard Deviation 0.89 |
| Stenfilcon A | Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy) | 12-hours | 1.47 units on a scale | Standard Deviation 1.16 |
| Stenfilcon A | Investigator's Objective Assessment of Lens Surface Wettability (Biomicroscopy) | 1-week | 1.15 units on a scale | Standard Deviation 0.98 |
Secondary
Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy)
Investigators assigned an overall fit acceptance grade by biomicroscopy assessment (grading scale, 0-4, 0=very poor, 4=very good). Change over time measured at insertion, 12-hours, 1-week
Time frame: Insertion, 12 hours, 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy) | Insertion | 3.37 units on a scale | Standard Deviation 0.47 |
| Etafilcon A | Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy) | 12-hours | 3.26 units on a scale | Standard Deviation 0.47 |
| Etafilcon A | Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy) | 1-week | 3.36 units on a scale | Standard Deviation 0.4 |
| Stenfilcon A | Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy) | Insertion | 3.44 units on a scale | Standard Deviation 0.42 |
| Stenfilcon A | Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy) | 12-hours | 3.40 units on a scale | Standard Deviation 0.37 |
| Stenfilcon A | Investigator's Objective Assessment of Overall Fit Acceptance (Biomicroscopy) | 1-week | 3.48 units on a scale | Standard Deviation 0.31 |
Secondary
Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen)
Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at normal lighting conditions (high illumination). (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week.
Time frame: Insertion
| Arm | Measure | Group | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen) | Insertion | -0.09 logMAR | Standard Deviation 0.09 |
| Etafilcon A | Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen) | 12-hours | -0.09 logMAR | Standard Deviation 0.07 |
| Etafilcon A | Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen) | 1-week | -0.09 logMAR | Standard Deviation 0.06 |
| Stenfilcon A | Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen) | Insertion | -0.08 logMAR | Standard Deviation 0.08 |
| Stenfilcon A | Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen) | 12-hours | -0.08 logMAR | Standard Deviation 0.07 |
| Stenfilcon A | Investigator's Objective Assessment of Visual Acuity, High Contrast at High Illumination (Snellen) | 1-week | -0.08 logMAR | Standard Deviation 0.07 |
Secondary
Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen)
Investigators tested participants using snellen charts distant to the participant in each eye (monocular) at low lighting conditions (low illumination). (logMAR, 0.00 = 20/20 Snellen acuity, positive values = poorer visual acuity, negative values = better visual acuity). Change over time measured at insertion, 12-hours, 1-week.
Time frame: Insertion, 12-hours, 1-week
| Arm | Measure | Group | Value (LOG_MEAN) | Dispersion |
|---|---|---|---|---|
| Etafilcon A | Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen) | Insertion | -0.07 logMAR | Standard Deviation 0.08 |
| Etafilcon A | Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen) | 12-hours | -0.07 logMAR | Standard Deviation 0.07 |
| Etafilcon A | Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen) | 1-week | -0.08 logMAR | Standard Deviation 0.07 |
| Stenfilcon A | Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen) | Insertion | -0.06 logMAR | Standard Deviation 0.07 |
| Stenfilcon A | Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen) | 12-hours | -0.07 logMAR | Standard Deviation 0.07 |
| Stenfilcon A | Investigator's Objective Assessment of Visual Acuity, High Contrast at Low Illumination (Snellen) | 1-week | -0.07 logMAR | Standard Deviation 0.07 |