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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| enfilcon A / omafilcon A | Experimental | 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. |
|
| enfilcon A / ocufilcon D | Active Comparator | 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. |
|
| enfilcon A / methafilcon A | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ocufilcon D | Device | Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contra lateral eye. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 1 hour post settling |
| 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). | 1 hour post settling |
| 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). | 1 hour post settling |
| 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). | Baseline |
| 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). | Baseline |
| 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). | Baseline |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Montés-Mico, OD MPhil PhD | Optics Department, University of Valencia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Optometry Research Group (GIO) Optics Department, University of Valencia | Valencia | 46100 | Spain |
There were 60 subjects enrolled and fitted with the study lenses. All sixty subjects completed the trial (i.e. no discontinuations).
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| ID | Title | Description |
|---|---|---|
| FG000 | Overall Participants Flow | 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. omafilcon A/ocufilcon D/methafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A)/(ocufilcon D)/(methafilcon A)in the contra lateral eye. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | units on a scale | 1 hour post settling |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Enfilcon A / Omafilcon 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. omafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Robert Montés-Mico O.D., MPhil, PhD | Optics Department, University of Valencia 46100 Valencia, Spain | 34-9635-44764 | robert.montes@uv.es |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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|
| omafilcon A | Device | Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye. |
|
|
| methafilcon A | Device | Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye. |
|
|
| 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). | 1 hour post settling |
| 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). | 1 hour post settling |
| 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). | 1 hours post settling |
| 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). | Baseline |
| 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). | Baseline |
| 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). | Baseline |
| 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). | 1 hour post settling |
| 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). | 1 hour post settling |
| 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). | 1 hour post settling |
| 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) | 1 hour post settling |
| 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) | 1 hour post settling |
| 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) | 1 hour post settling |
| 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). | 1 hour post settling |
| 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). | 1 hour post settling |
| 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) | 1 hour post settling |
| 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). | 1 hour post settling |
| 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) | 1 hour post settling |
| 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) | 1 hour post settling |
| 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). | Baseline |
| 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) | Baseline |
| 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). | Baseline |
| 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). | 1 hour post settling |
| 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). | 1 hour post settling |
| 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). | 1 hour post settling |
| 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) | 1 hour post settling |
| 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) | 1 hour post settling |
| 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) | 1 hour post settling |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | 1 hour post settling |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | 1 hour post settling |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
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| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| 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). | Posted | Mean | Standard Deviation | units on a scale | 1 hour post settling |
|
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| 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). | Posted | Mean | Standard Deviation | units on a scale | 1 hour post settling |
|
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| 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). | Posted | Mean | Standard Deviation | units on a scale | 1 hours post settling |
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| 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). | Posted | Number | percentage of subjects | Baseline |
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| 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). | Posted | Number | percentage of subjects | Baseline |
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| 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). | Posted | Number | percentage of eyes | Baseline |
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| 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). | Posted | Number | percentage of subjects | 1 hour post settling |
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| 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). | Posted | Number | percentage of subjects | 1 hour post settling |
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| 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). | Posted | Number | percentage of subjects | 1 hour post settling |
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| 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) | Posted | Mean | Standard Deviation | units on a scale | 1 hour post settling |
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| 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) | Posted | Mean | Standard Deviation | units on a scale | 1 hour post settling |
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| 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) | Posted | Mean | Standard Deviation | units on a scale | 1 hour post settling |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | 1 hour post settling |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | 1 hour post settling |
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| 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) | Posted | Mean | Standard Deviation | units on a scale | 1 hour post settling |
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| 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). | Posted | Number | percentage of eyes | 1 hour post settling | Eyes | Eyes |
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| 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) | Posted | Number | percentage of eyes | 1 hour post settling | Eyes | Eyes |
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| 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) | Posted | Number | percentage of eyes | 1 hour post settling | Eyes | Eyes |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| 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) | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | Baseline |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | 1 hour post settling |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | 1 hour post settling |
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| 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). | Posted | Mean | Standard Deviation | units on a scale | 1 hour post settling |
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| 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) | Posted | Mean | Standard Deviation | LogMAR | 1 hour post settling |
|
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| 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) | Posted | Mean | Standard Deviation | LogMAR | 1 hour post settling |
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| 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) | Posted | Mean | Standard Deviation | LogMAR | 1 hour post settling |
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|
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Enfilcon A / Ocufilcon D | 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. ocufilcon D: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contra lateral eye. | 0 | 60 | 0 | 60 |
| EG002 | Enfilcon A / 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. methafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye. | 0 | 60 | 0 | 60 |
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The investigators will not be permitted to publish or present at scientific meetings results obtained from the clinical study without prior written consent from the sponsor.
| No Preference |
|
| Slight Omafilcon A |
|
| Strong Omafilcon A |
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| No Preference |
|
| Slight Ocufilcon D |
|
| Strong Ocufilcon D |
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| No Preference |
|
| Slight Methafilcon A |
|
| Strong Methfilcon A |
|
| No preference |
|
| Slight Omafilcon A |
|
| Strong Omafilcon A |
|
| No Preference |
|
| Slight Ocufilcon D |
|
| Strong Ocufilcon D |
|
| No Preference |
|
| Slight Methafilcon A |
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| Strong Methafilcon A |
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| Decentration unacceptable |
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| Decentration Unacceptable |
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| Decentration unacceptable |
|