Myopia
Conditions
Brief summary
The aim of this non-dispensing fitting study is to evaluate the subjective comfort, lens handling, lens fitting characteristics and visual acuity of different hydrogel lens designs versus silicone hydrogel lenses
Detailed description
This is a 60-subject, double masked, randomized, contra lateral, non-dispensing fitting trial comparing different lens materials (hydrogel vs silicone hydrogel). It is anticipated that this study will involve 2 visits, for each lens pair, as follows: Visits: V1 (lens dispensing), V2 (1 hour post lens settling). Each subject will be randomized to wear the test and control lenses in a series of three short fitting comparisons.
Interventions
DEVICEocufilcon D
Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contra lateral eye.
DEVICEomafilcon A
Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye.
DEVICEmethafilcon A
Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye.
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Is between 18 and 40 years of age (inclusive) * Has had a self-reported visual exam in the last two years * Is an adapted soft CL (Contact Lens) wearer * Has a CL spherical prescription between - 1.00 and - 10.00 (inclusive) * Has a spectacle cylinder up to 0.75D (Diopter) in each eye. * Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye. * Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses. * Has clear corneas and no active ocular disease * Has read, understood and signed the information consent letter * Patient contact lens refraction should fit within the available parameters of the study lenses * Is willing to comply with the wear schedule * Is willing to comply with the visit schedule
Exclusion criteria
* Has never worn contact lenses before. * Currently wears rigid gas permeable contact lenses. * Has a history of not achieving comfortable CL wear (5 days per week; \> 8 hours/day) * Has a CL prescription outside the range of - 1.00 to -10.00D * Has a spectacle cylinder ≥1.00D of cylinder in either eye. * Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye. * Presence of clinically significant (grade 2-4) anterior segment abnormalities. * Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear. * Slit lamp findings that would contraindicate contact lens wear such as: * Pathological dry eye or associated findings * Pterygium, pinguecula, or corneal scars within the visual axis * Neovascularization \> 0.75 mm in from of the limbus * Giant papillary conjunctivitis (GCP) worse than grade 1 * Anterior uveitis or iritis (past or present) * Seborrheic eczema, Seborrheic conjunctivitis * History of corneal ulcers or fungal infections * Poor personal hygiene * Has a known history of corneal hypoesthesia (reduced corneal sensitivity) * Has aphakia, keratoconus or a highly irregular cornea. * Has Presbyopia or has dependence on spectacles for near work over the contact lenses. * Has undergone corneal refractive surgery. * Is participating in any other type of eye related clinical or research study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant's Subjective Rating for Lens Handling - Enfilcon A / Ocufilcon D | 1 hour post settling | Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2 (1 hour). Rated by questionnaires (0=Very difficult 0-100, 100= very easy). |
| Participant's Subjective Rating for Lens Handling - Enfilcon A / Omafilcon A | 1 hour post settling | Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1 (1 hour). Rated by questionnaires (0= Very difficult 0-100, 100= very easy). |
| Participant's Subjective Rating for Lens Handling - Enfilcon A / Methafilcon A | 1 hour post settling | Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3. Rated by questionnaires (0-100 0=Very difficult, 100= very easy). |
| Participants Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D | Baseline | Surveyed after insertion of each lens Pair #2 (at insertion). Rated by Questionnaire (0-100,0=Can't be worn and causes pain, 100=can't feel). |
| Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A | Baseline | Surveyed after insertion of each lens at baseline visit for Pair #1. Rated by questionnaires (0-100, 0-Can't be worn and causes pain,100= can't feel). |
| Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A | Baseline | Surveyed after insertion Pair #3 (baseline). Rated by questionnaires (0-100, 0-Can't be worn, 100= can't feel). |
| Participant's Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D | 1 hour post settling | Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100 0=Can't be worn and causes pain, 100= can't feel). |
| Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | Baseline | Surveyed after insertion of each lens Pair #1 at (Baseline visit). Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A). |
| Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | Baseline | Surveyed at insertion of each lens Pair #2 by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D). |
| Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | Baseline | Surveyed after insertion of each lens for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A). |
| Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | 1 hour post settling | Surveyed after 1 hour post settling (1 hour) of lens wear for Pair #1. Rated by subjects preference for test lens or control lens (Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A). |
| Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | 1 hour post settling | Surveyed after 1 hour post settling for Pair #2. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D). |
| Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | 1 hour post settling | Surveyed after 1 hour post settling for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A). |
| Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Omafilcon A | 1 hour post settling | Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement) |
| Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Ocufilcon D | 1 hour post settling | Assessed after 1 hour post settling for Pair #2. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement) |
| Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Methafilcon A | 1 hour post settling | Assessed after 1 hour post settling for Pair #3. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement) |
| Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Omafilcon A | 1 hour post settling | Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp. (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support). |
| Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Ocufilcon D | 1 hour post settling | Assessed after 1 hour post settling for Pair #2, (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support). |
| Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Methafilcon A | 1 hour post settling | Assessed after 1 hour post settling for Pair #3. (Scale 0%-100%, 0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support) |
| Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A | 1 hour post settling | Assessed after 1 hour post settling of lens wear for Pair #1. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable). |
| Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D | 1 hour post settling | Assessed after 1 hour post settling for Pair #2. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable) |
| Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A | 1 hour post settling | Assessed after 1 hour post settling for Pair #3, (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable) |
| Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A | Baseline | Surveyed after insertion of each lens for Pair #1 at baseline visit. Rated by questionnaires (0-100, 0=no sensation of stinging/burning, 100= extreme stinging). |
| Participant Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D | Baseline | Surveyed after insertion of each lens Pair #2 at baseline. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging) |
| Participant Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A | Baseline | Surveyed after insertion of each lens for Pair #3. Rated by questionnaires (0-100,0=no sensation of stinging/burning, 100=extreme stinging). |
| Participants Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A | 1 hour post settling | Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging). |
| Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D | 1 hour post settling | Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100,0= no sensation of stinging/burning, 100= extreme stinging). |
| Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A | 1 hour post settling | Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0= no sensation of stinging/burning,100= extreme stinging). |
| Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Omafilcon A | 1 hour post settling | Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs Pair #1. LogMAR Visual Acuity (VA) to nearest letter) |
| Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Ocufilcon D | 1 hour post settling | Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #2. LogMAR Visual Acuity (VA) to nearest letter) |
| Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Methafilcon A | 1 hour post settling | Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #3. LogMAR Visual Acuity (VA) to nearest letter) |
Countries
Spain
Participant flow
Pre-assignment details
There were 60 subjects enrolled and fitted with the study lenses. All sixty subjects completed the trial (i.e. no discontinuations).
Participants by arm
| Arm | Count |
|---|---|
| Enfilcon A / Omafilcon A/Ocufilcon D/Methafilcon A Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.
Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contralateral eye. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye. | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Enfilcon A / Omafilcon A/Ocufilcon D/Methafilcon A |
|---|---|
| Age, Continuous | 25.78 years STANDARD_DEVIATION 5.34 |
| Sex: Female, Male Female | 34 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 60 | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 0 / 60 | 0 / 60 | 0 / 60 |
Outcome results
Primary
Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Methafilcon A
Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #3. LogMAR Visual Acuity (VA) to nearest letter)
Time frame: 1 hour post settling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Methafilcon A | -0.041 LogMAR | Standard Deviation 0.049 |
| Omafilcon A | Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Methafilcon A | -0.043 LogMAR | Standard Deviation 0.05 |
Primary
Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Ocufilcon D
Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs- Pair #2. LogMAR Visual Acuity (VA) to nearest letter)
Time frame: 1 hour post settling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Ocufilcon D | -0.041 LogMAR | Standard Deviation 0.049 |
| Omafilcon A | Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Ocufilcon D | -0.040 LogMAR | Standard Deviation 0.049 |
Primary
Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Omafilcon A
Visual acuity assessed after insertion of each study lens, prior to dispensing contralateral pairs Pair #1. LogMAR Visual Acuity (VA) to nearest letter)
Time frame: 1 hour post settling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Omafilcon A | -0.041 LogMAR | Standard Deviation 0.049 |
| Omafilcon A | Eye Care Practitioner's Objective Assessment of Binocular High Contrast Distance Visual Acuity - Enfilcon A / Omafilcon A | -0.035 LogMAR | Standard Deviation 0.055 |
Primary
Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A
Assessed after 1 hour post settling for Pair #3, (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)
Time frame: 1 hour post settling
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enfilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A | Optimum | 100 percentage of eyes |
| Enfilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A | Decentration acceptable | 0 percentage of eyes |
| Enfilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A | Decentration unacceptable | 0 percentage of eyes |
| Omafilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A | Optimum | 100 percentage of eyes |
| Omafilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A | Decentration acceptable | 0 percentage of eyes |
| Omafilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Methafilcon A | Decentration unacceptable | 0 percentage of eyes |
Primary
Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D
Assessed after 1 hour post settling for Pair #2. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable)
Time frame: 1 hour post settling
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enfilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D | Optimum | 100 percentage of eyes |
| Enfilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D | Decentration Acceptable | 0 percentage of eyes |
| Enfilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D | Decentration Unacceptable | 0 percentage of eyes |
| Omafilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D | Optimum | 100 percentage of eyes |
| Omafilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D | Decentration Acceptable | 0 percentage of eyes |
| Omafilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Ocufilcon D | Decentration Unacceptable | 0 percentage of eyes |
Primary
Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A
Assessed after 1 hour post settling of lens wear for Pair #1. (4 possible ratings: optimum, Decentration acceptable, Decentration unacceptable).
Time frame: 1 hour post settling
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enfilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A | Optimum | 100 percentage of eyes |
| Enfilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A | Decentration acceptable | 0 percentage of eyes |
| Enfilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A | Decentration unacceptable | 0 percentage of eyes |
| Omafilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A | Optimum | 100 percentage of eyes |
| Omafilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A | Decentration acceptable | 0 percentage of eyes |
| Omafilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Centration - Enfilcon A / Omafilcon A | Decentration unacceptable | 0 percentage of eyes |
Primary
Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Methafilcon A
Assessed after 1 hour post settling for Pair #3. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)
Time frame: 1 hour post settling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Methafilcon A | 2.0 units on a scale | Standard Deviation 0 |
| Omafilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Methafilcon A | 2.0 units on a scale | Standard Deviation 0 |
Primary
Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Ocufilcon D
Assessed after 1 hour post settling for Pair #2. (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)
Time frame: 1 hour post settling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Ocufilcon D | 2.0 units on a scale | Standard Deviation 0 |
| Omafilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Ocufilcon D | 2.0 units on a scale | Standard Deviation 0 |
Primary
Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Omafilcon A
Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp (0-4, 0=Insufficient, unacceptable movement, 1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement)
Time frame: 1 hour post settling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Omafilcon A | 2.0 units on a scale | Standard Deviation 0 |
| Omafilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Post-blink Movement, and Primary Gaze Lag - Enfilcon A / Omafilcon A | 2.0 units on a scale | Standard Deviation 0 |
Primary
Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Methafilcon A
Assessed after 1 hour post settling for Pair #3. (Scale 0%-100%, 0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support)
Time frame: 1 hour post settling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Methafilcon A | 50 units on a scale | Standard Deviation 0.91 |
| Omafilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Methafilcon A | 50 units on a scale | Standard Deviation 0.65 |
Primary
Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Ocufilcon D
Assessed after 1 hour post settling for Pair #2, (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support).
Time frame: 1 hour post settling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Ocufilcon D | 50 units on a scale | Standard Deviation 0.65 |
| Omafilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Ocufilcon D | 50 units on a scale | Standard Deviation 0.65 |
Primary
Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Omafilcon A
Assessed after 1 hour post settling of lens wear for Pair #1. Slit lamp. (0%-100%, continuous scale where 100%=no movement, 50%=optimum, 0%=Falls from cornea without lid support).
Time frame: 1 hour post settling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Omafilcon A | 50 units on a scale | Standard Deviation 1.8 |
| Omafilcon A | Eye Care Practitioner's Objective Assessment of Lens Fit, Tightness Push-up Test - Enfilcon A / Omafilcon A | 50 units on a scale | Standard Deviation 1.8 |
Primary
Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A
Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0=Can't be worn and causes pain 100= can't feel).
Time frame: 1 hours post settling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A | 96 units on a scale | Standard Deviation 6.7 |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A | 78 units on a scale | Standard Deviation 17.7 |
Primary
Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A
Surveyed after insertion Pair #3 (baseline). Rated by questionnaires (0-100, 0-Can't be worn, 100= can't feel).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A | 94 units on a scale | Standard Deviation 9.3 |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort - Enfilcon A / Methafilcon A | 76 units on a scale | Standard Deviation 18.7 |
Primary
Participant's Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D
Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100 0=Can't be worn and causes pain, 100= can't feel).
Time frame: 1 hour post settling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Participant's Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D | 96 units on a scale | Standard Deviation 6.1 |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D | 83 units on a scale | Standard Deviation 18.6 |
Primary
Participants Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D
Surveyed after insertion of each lens Pair #2 (at insertion). Rated by Questionnaire (0-100,0=Can't be worn and causes pain, 100=can't feel).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Participants Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D | 94 units on a scale | Standard Deviation 9.3 |
| Omafilcon A | Participants Subjective Rating for Lens Comfort - Enfilcon A / Ocufilcon D | 82 units on a scale | Standard Deviation 18.6 |
Primary
Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A
Surveyed after insertion of each lens at baseline visit for Pair #1. Rated by questionnaires (0-100, 0-Can't be worn and causes pain,100= can't feel).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A | 94 units on a scale | Standard Deviation 8.5 |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A | 73 units on a scale | Standard Deviation 17 |
Primary
Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A
Surveyed after 1 hour post settling for Pair #1. Rated by questionnaires (0-100, 0= Can't be worn and causes pain, 100= can't feel).
Time frame: 1 hour post settling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A | 98 units on a scale | Standard Deviation 4.2 |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort - Enfilcon A / Omafilcon A | 76 units on a scale | Standard Deviation 16.4 |
Primary
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A
Surveyed after 1 hour post settling for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).
Time frame: 1 hour post settling
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enfilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | Slight Enfilcon A | 22 percentage of subjects |
| Enfilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | Slight Methafilcon A | 0 percentage of subjects |
| Enfilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | No Preference | 18 percentage of subjects |
| Enfilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | Strong Methafilcon A | 0 percentage of subjects |
| Enfilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | Strong Enfilcon A | 53 percentage of subjects |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | Strong Methafilcon A | 0 percentage of subjects |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | Strong Enfilcon A | 0 percentage of subjects |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | Slight Enfilcon A | 0 percentage of subjects |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | No Preference | 0 percentage of subjects |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | Slight Methafilcon A | 7 percentage of subjects |
Primary
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A
Surveyed after insertion of each lens for Pair #3. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Methafilcon A, Strong Methafilcon A).
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enfilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | Slight Enfilcon A | 18.3 percentage of eyes |
| Enfilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | Slight Methafilcon A | 0.0 percentage of eyes |
| Enfilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | No Preference | 18.3 percentage of eyes |
| Enfilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | Strong Methfilcon A | 0.0 percentage of eyes |
| Enfilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | Strong Enfilcon A | 55.0 percentage of eyes |
| Omafilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | Strong Methfilcon A | 3.3 percentage of eyes |
| Omafilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | Strong Enfilcon A | 0.0 percentage of eyes |
| Omafilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | Slight Enfilcon A | 0.0 percentage of eyes |
| Omafilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | No Preference | 0.0 percentage of eyes |
| Omafilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Methafilcon A | Slight Methafilcon A | 5.0 percentage of eyes |
Primary
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D
Surveyed after 1 hour post settling for Pair #2. Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).
Time frame: 1 hour post settling
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enfilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | Slight Enfilcon A | 18 percentage of subjects |
| Enfilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | Slight Ocufilcon D | 0 percentage of subjects |
| Enfilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | No Preference | 35 percentage of subjects |
| Enfilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | Strong Ocufilcon D | 0 percentage of subjects |
| Enfilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | Strong Enfilcon A | 42 percentage of subjects |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | Strong Ocufilcon D | 0 percentage of subjects |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | Strong Enfilcon A | 0 percentage of subjects |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | Slight Enfilcon A | 0 percentage of subjects |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | No Preference | 0 percentage of subjects |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | Slight Ocufilcon D | 5 percentage of subjects |
Primary
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D
Surveyed at insertion of each lens Pair #2 by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Ocufilcon D, Strong Ocufilcon D).
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enfilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | Slight Enfilcon A | 22 percentage of subjects |
| Enfilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | Slight Ocufilcon D | 0 percentage of subjects |
| Enfilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | No Preference | 35 percentage of subjects |
| Enfilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | Strong Ocufilcon D | 0 percentage of subjects |
| Enfilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | Strong Enfilcon A | 38 percentage of subjects |
| Omafilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | Strong Ocufilcon D | 0 percentage of subjects |
| Omafilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | Strong Enfilcon A | 0 percentage of subjects |
| Omafilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | Slight Enfilcon A | 0 percentage of subjects |
| Omafilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | No Preference | 0 percentage of subjects |
| Omafilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Ocufilcon D | Slight Ocufilcon D | 5 percentage of subjects |
Primary
Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A
Surveyed after 1 hour post settling (1 hour) of lens wear for Pair #1. Rated by subjects preference for test lens or control lens (Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).
Time frame: 1 hour post settling
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enfilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | Slight Enfilcon A | 20 percentage of subjects |
| Enfilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | Slight Omafilcon A | 0 percentage of subjects |
| Enfilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | No preference | 13 percentage of subjects |
| Enfilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | Strong Omafilcon A | 0 percentage of subjects |
| Enfilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | Strong Enfilcon A | 67 percentage of subjects |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | Strong Omafilcon A | 0 percentage of subjects |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | Strong Enfilcon A | 0 percentage of subjects |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | Slight Enfilcon A | 0 percentage of subjects |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | No preference | 0 percentage of subjects |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | Slight Omafilcon A | 0 percentage of subjects |
Primary
Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A
Surveyed after insertion of each lens Pair #1 at (Baseline visit). Rated by questionnaire (4 possible ratings: Strong Enfilcon A, Slight Enfilcon A, No preference, Slight Omafilcon A, Strong Omafilcon A).
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Enfilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | No Preference | 10.0 percentage of subjects |
| Enfilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | Slight Omafilcon A | 0.0 percentage of subjects |
| Enfilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | Strong Omafilcon A | 0.0 percentage of subjects |
| Enfilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | Strong Enfilcon A | 66.7 percentage of subjects |
| Enfilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | Slight Enfilcon A | 16.7 percentage of subjects |
| Omafilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | Slight Enfilcon A | 0.0 percentage of subjects |
| Omafilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | Strong Enfilcon A | 0.0 percentage of subjects |
| Omafilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | Slight Omafilcon A | 6.7 percentage of subjects |
| Omafilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | No Preference | 0.0 percentage of subjects |
| Omafilcon A | Participants Subjective Rating for Lens Comfort Preference - Enfilcon A / Omafilcon A | Strong Omafilcon A | 0.0 percentage of subjects |
Primary
Participant's Subjective Rating for Lens Handling - Enfilcon A / Methafilcon A
Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3. Rated by questionnaires (0-100 0=Very difficult, 100= very easy).
Time frame: 1 hour post settling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Participant's Subjective Rating for Lens Handling - Enfilcon A / Methafilcon A | 97 units on a scale | Standard Deviation 6.5 |
| Omafilcon A | Participant's Subjective Rating for Lens Handling - Enfilcon A / Methafilcon A | 86 units on a scale | Standard Deviation 17.7 |
Primary
Participant's Subjective Rating for Lens Handling - Enfilcon A / Ocufilcon D
Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2 (1 hour). Rated by questionnaires (0=Very difficult 0-100, 100= very easy).
Time frame: 1 hour post settling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Participant's Subjective Rating for Lens Handling - Enfilcon A / Ocufilcon D | 96 units on a scale | Standard Deviation 8.9 |
| Omafilcon A | Participant's Subjective Rating for Lens Handling - Enfilcon A / Ocufilcon D | 90 units on a scale | Standard Deviation 13.7 |
Primary
Participant's Subjective Rating for Lens Handling - Enfilcon A / Omafilcon A
Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1 (1 hour). Rated by questionnaires (0= Very difficult 0-100, 100= very easy).
Time frame: 1 hour post settling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Participant's Subjective Rating for Lens Handling - Enfilcon A / Omafilcon A | 97 units on a scale | Standard Deviation 8.2 |
| Omafilcon A | Participant's Subjective Rating for Lens Handling - Enfilcon A / Omafilcon A | 84 units on a scale | Standard Deviation 20.2 |
Primary
Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A
Surveyed after 1 hour post settling for Pair #3. Rated by questionnaires (0-100,0= no sensation of stinging/burning,100= extreme stinging).
Time frame: 1 hour post settling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A | 1.2 units on a scale | Standard Deviation 3.2 |
| Omafilcon A | Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A | 13 units on a scale | Standard Deviation 18.7 |
Primary
Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D
Surveyed after 1 hour post settling for Pair #2. Rated by questionnaires (0-100,0= no sensation of stinging/burning, 100= extreme stinging).
Time frame: 1 hour post settling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D | 1.4 units on a scale | Standard Deviation 3.5 |
| Omafilcon A | Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D | 8.8 units on a scale | Standard Deviation 13.9 |
Primary
Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A
Surveyed after insertion of each lens for Pair #1 at baseline visit. Rated by questionnaires (0-100, 0=no sensation of stinging/burning, 100= extreme stinging).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A | 2.6 units on a scale | Standard Deviation 6 |
| Omafilcon A | Participant's Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A | 18 units on a scale | Standard Deviation 22.6 |
Primary
Participants Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A
Surveyed after 1 hour of lens wear for each lens at lens removal Pair #1. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging).
Time frame: 1 hour post settling
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Participants Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A | 0.6 units on a scale | Standard Deviation 2.3 |
| Omafilcon A | Participants Subjective Rating for Stinging/Burning - Enfilcon A / Omafilcon A | 8.8 units on a scale | Standard Deviation 13.4 |
Primary
Participant Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A
Surveyed after insertion of each lens for Pair #3. Rated by questionnaires (0-100,0=no sensation of stinging/burning, 100=extreme stinging).
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Participant Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A | 2.0 units on a scale | Standard Deviation 4 |
| Omafilcon A | Participant Subjective Rating for Stinging/Burning - Enfilcon A / Methafilcon A | 15 units on a scale | Standard Deviation 19.8 |
Primary
Participant Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D
Surveyed after insertion of each lens Pair #2 at baseline. Rated by questionnaires (0-100,0=no sensation of stinging/burning 100=extreme stinging)
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Enfilcon A | Participant Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D | 3.3 units on a scale | Standard Deviation 9.5 |
| Omafilcon A | Participant Subjective Rating for Stinging/Burning - Enfilcon A / Ocufilcon D | 11 units on a scale | Standard Deviation 20.3 |