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Evaluate the clinical performance of existing wearers of hydrogel toric lenses when refitted with Avaira toric silicone hydrogel contact lenses over 1 week of wear.
This is a 60-subject, single masked, bilateral, parallel study design comparing the fitting characteristics of enfilcon A toric lenses against the subjects habitual hydrogel toric lenses (omafilcon A, ocufilcon D or methafilcon B wearers). Subject's habitual toric lenses will be evaluated at the first visit and then re-fitted with a pair of Avaira toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Omafilcon A/Enfilcon A | Active Comparator | Subject's habitual hydrogel toric lenses Omafilcon A will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses. |
|
| Ocufilcon D/Enfilcon A | Active Comparator | Subject's habitual hydrogel toric lenses Ocufilcon D will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses. |
|
| Methafilcon B/ Enfilcon A | Active Comparator | Subject's habitual hydrogel toric lenses Methafilcon B will be evaluated at the first visit and then re-fitted with a pair of Enfilcon A lenses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| enfilcon A | Device | Silicone hydrogel toric lenses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Participant's Subjective Rating for Lens Initial Comfort | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel) | Baseline and 1 week |
| Participant's Subjective Rating for Lens Comfort Prior to Removal | Surveyed prior to removal of each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel) | Baseline and 1 week |
| Participant's Subjective Rating for Overall Lens Comfort | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel) | Baseline and 1 week |
| Participant's Subjective Rating for Dryness During the Day | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness) | Baseline and 1 week |
| Participant's Subjective Rating for Dryness Prior to Removal | Surveyed prior to removal of each lens pair. Habitual pair at baseline . Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness) | Baseline and 1 week |
| Participant's Subjective Rating for Overall Dryness | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness) |
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Inclusion Criteria:
Exclusion Criteria:
Has a contact lens prescription outside the range of the available parameters of the study lenses.
Has a spectacle cylinder less than -0.75D or more than -1.75D of cylinder in either eye.
Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day)
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 | Optometry Research Group (GIO) 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Omafilcon A/Enfilcon A | Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A). |
| FG001 | Ocufilcon D/Enfilcon A | Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A). |
| FG002 | Methafilcon B/Enfilcon A | Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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The subject sample consisted of 60 habitual hydrogelcontact lens wearers (omafilcon A, ocufilcon D or methafilcon B), refitted with silicone hydrogel lens (enfilcon A)
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| ID | Title | Description |
|---|---|---|
| BG000 | Overall Study Group | All participants were habitual wearers of hydrogel toric lenses (omafilcon A, ocufilcon D or methafilcon B), and refitted with silicone hydrogel toric lens (enfilcon A) |
| Units | Counts |
|---|---|
| Participants |
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| 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 Initial Comfort | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
|
From Dispense up to one week for each study lenses
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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 | Omafilcon A | Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation. enfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Montés-Mico O.D., MPhil, PhD Optometry | Optometry Research Group (GIO) | 34-9635-44764 | robert.montes@uv.es |
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| ID | Term |
|---|---|
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Baseline and 1 week |
| Participant's Subjective Rating for Lens Handling - Insertion | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= very easy) | Baseline and 1 week |
| Participant's Subjective Rating for Overall Lens Fit Stability | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very unstable / excessive movement, 10= very stable / good movement) | Baseline and 1 week |
| Participant's Subjective Rating for Overall Vision Satisfaction | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=completely dissatisfied, 10= very satisfied) | Baseline and 1 week |
| Participant's Subjective Rating for Vision Quality at Insertion | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week .Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp) | Baseline and 1 week |
| Participant's Subjective Rating for Vision Quality During the Day | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp) | Baseline and 1 week |
| Participant's Subjective Rating for Vision Quality End of the Day | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week end of the day. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp) | Baseline and 1 week |
| Participant's Subjective Rating for Night Vision Quality | Surveyed for each lens pair. Habitual pair at baseline. Study pair dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp) | Baseline and 1 week |
| Participant's Subjective Rating for Vision Stability at Insertion | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing) | Baseline and 1 week |
| Participant's Subjective Rating for Vision Stability During the Day | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing) | Baseline and 1 week |
| Participant's Subjective Rating for Vision Stability at End of Day | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing) | Baseline and 1 week |
| Participant's Subjective Rating for Lens Pair Preference | Participants subjective preference in relation to comfort, dryness, handling, vision, lens fit and overall of the patient after wearing the study and their habitual lenses. | 1 week |
| Participant's Subjective Rating for Overall Satisfaction - Dryness | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied) | Baseline and 1 week |
| Participant's Subjective Rating for Overall Satisfaction - Handling | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied) | Baseline and 1 week |
| Participant's Subjective Rating for Overall Satisfaction - Vision | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied) | Baseline and 1 week |
| Participant's Subjective Rating for Overall Satisfaction - Lens Fit | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied) | Baseline and 1 week |
| Participant's Subjective Rating for Overall Satisfaction - Overall | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied) | Baseline and 1 week |
| Clinician's Objective Assessment Monocular High Contrast Distance Visual | Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value. | Baseline and 1 week |
| Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity | Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value | Baseline and 1 week |
| Clinician's Assessment Overall Lens Stability-Right Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent) | Baseline and 1 week |
| Clinician's Assessment Overall Lens Stability-Left Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent) | Baseline and 1 week |
| Clinician's Assessment Overall Fit Acceptance- Right Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent) | Baseline and 1 week |
| Clinician's Assessment Overall Fit Acceptance- Left Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent) | Baseline and 1 week |
| Clinician's Assessment Lens Centration-Right Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Lens centration recorded by degree and direction in the primary position. (0-2, 0=centered/optimal, 1=decentered slightly, 2=substantially decentered (>0.5mm)) | Baseline and 1 week |
| Clinician's Assessment Lens Centration- Left Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Lens centration recorded by degree and direction in the primary positions. (0-2, 0=centered/optimal, 1=decentered slightlty, 2=substantially decentered (>0.5mm) | Baseline and 1 week |
| Clinician's Assessment Corneal Coverage-Right Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no, incomplete corneal coverage) | Baseline and 1 week |
| Clinicians Assessment Corneal Coverage-Left Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no incomplete corneal coverage) | Baseline and 1 week |
| Clinician's Assessment Post-Blink Movement- Right Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement | Baseline and 1 week |
| Clinician's Assessment Post-Blink Movement-Left Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement | Baseline and 1 week |
| Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye | Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees. | Baseline and 1 week |
| Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye | Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees. | Baseline and 1 week |
| Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye | Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally. | Baseline and 1 week |
| Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye | Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally. | Baseline and 1 week |
| Participant's Subjective Rating for Overall Satisfaction - Comfort | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied) | Baseline and 1 week |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| OG002 | Methafilcon B | Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A). |
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| Primary | Participant's Subjective Rating for Lens Comfort Prior to Removal | Surveyed prior to removal of each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
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| Primary | Participant's Subjective Rating for Overall Lens Comfort | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= can't feel) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
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| Primary | Participant's Subjective Rating for Dryness During the Day | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
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| Primary | Participant's Subjective Rating for Dryness Prior to Removal | Surveyed prior to removal of each lens pair. Habitual pair at baseline . Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
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| Primary | Participant's Subjective Rating for Overall Dryness | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-10, 0=very dry, 10= no dryness) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
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| Primary | Participant's Subjective Rating for Lens Handling - Insertion | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=poor, 10= very easy) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
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| Primary | Participant's Subjective Rating for Overall Lens Fit Stability | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=very unstable / excessive movement, 10= very stable / good movement) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
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| Primary | Participant's Subjective Rating for Overall Vision Satisfaction | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-10, 0=completely dissatisfied, 10= very satisfied) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
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| Primary | Participant's Subjective Rating for Vision Quality at Insertion | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week .Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
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| Primary | Participant's Subjective Rating for Vision Quality During the Day | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
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| Primary | Participant's Subjective Rating for Vision Quality End of the Day | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week end of the day. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
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| Primary | Participant's Subjective Rating for Night Vision Quality | Surveyed for each lens pair. Habitual pair at baseline. Study pair dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=extremely poor vision totally blurred, 100= excellent vision totally sharp) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
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| Primary | Participant's Subjective Rating for Vision Stability at Insertion | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
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| Primary | Participant's Subjective Rating for Vision Stability During the Day | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
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| Primary | Participant's Subjective Rating for Vision Stability at End of Day | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Rated on a visual analog scale (VAS). (0-100, 0=Totally unstable Fluctuating/changing, 100= perfectly stable Not fluctuating/changing) | Posted | Mean | Standard Deviation | units on a scale | Baseline and 1 week |
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| Primary | Participant's Subjective Rating for Lens Pair Preference | Participants subjective preference in relation to comfort, dryness, handling, vision, lens fit and overall of the patient after wearing the study and their habitual lenses. | All 60 paticipants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. "Vision" category data for one participant was not collected. | Posted | Number | Percentage of eyes | 1 week | eyes | eyes |
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| Primary | Participant's Subjective Rating for Overall Satisfaction - Dryness | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied) | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Number | percentage of eyes | Baseline and 1 week | Eyes | Eyes |
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| Primary | Participant's Subjective Rating for Overall Satisfaction - Handling | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied) | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. Sum of percentage for the Study Lens Arm=101 as, Category title- " Somewhat dissatisfied- 1.7 was rounded to 2. | Posted | Number | percentage of eyes | Baseline and 1 week | Eyes | Eyes |
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| Primary | Participant's Subjective Rating for Overall Satisfaction - Vision | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week . Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied) | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Number | percentage of eyes | Baseline and 1 week | Eyes | Eyes |
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| Primary | Participant's Subjective Rating for Overall Satisfaction - Lens Fit | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied) | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Number | percentage of eyes | Baseline and 1 week | Eyes | Eyes |
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| Primary | Participant's Subjective Rating for Overall Satisfaction - Overall | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied) | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Number | percentage of eyes | Baseline and 1 week | Eyes | Eyes |
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| Primary | Clinician's Objective Assessment Monocular High Contrast Distance Visual | Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value. | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Mean | Standard Deviation | LogMAR | Baseline and 1 week |
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| Primary | Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity | Assessed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. LogMAR - Positive values denote poorer vision, negative values denote better vision than baseline 20/20 value | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Mean | Standard Deviation | LogMAR | Baseline and 1 week |
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| Primary | Clinician's Assessment Overall Lens Stability-Right Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent) | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Number | percentage of eyes | Baseline and 1 week | Eyes | Eyes |
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| Primary | Clinician's Assessment Overall Lens Stability-Left Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall performance of the lens in terms of axis stability on primary gaze, during lateral gaze, rotational recovery, and mislocation of the lens on blinking. Likert scale. (0-4, 0=very poor,1=poor, 2=moderate, 3=good, 4= excellent) | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Number | percentage of eyes | Baseline and 1 week | Eyes | Eyes |
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| Primary | Clinician's Assessment Overall Fit Acceptance- Right Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent) | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Number | percentage of eyes | Baseline and 1 week | Eyes | Eyes |
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| Primary | Clinician's Assessment Overall Fit Acceptance- Left Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Overall fit acceptance based on lens fit alone (not comfort or vision). Likert scale. (0-4, 0=Very poor 1=Poor 2=Moderate, 3=Good, 4= Excellent) | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Number | percentage of eyes | Baseline and 1 week | Eyes | Eyes |
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| Primary | Clinician's Assessment Lens Centration-Right Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Lens centration recorded by degree and direction in the primary position. (0-2, 0=centered/optimal, 1=decentered slightly, 2=substantially decentered (>0.5mm)) | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Number | percentage of eyes | Baseline and 1 week | Eyes | Eyes |
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| Primary | Clinician's Assessment Lens Centration- Left Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Lens centration recorded by degree and direction in the primary positions. (0-2, 0=centered/optimal, 1=decentered slightlty, 2=substantially decentered (>0.5mm) | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Number | percentage of eyes | Baseline and 1 week | Eyes | Eyes |
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| Primary | Clinician's Assessment Corneal Coverage-Right Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no, incomplete corneal coverage) | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Number | percentage of eyes | Baseline and 1 week | Eyes | Eyes |
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| Primary | Clinicians Assessment Corneal Coverage-Left Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed in primary gaze. (Y=yes, full corneal coverage at all times, N=no incomplete corneal coverage) | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Number | percentage of eyes | Baseline and 1 week | Eyes | Eyes |
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| Primary | Clinician's Assessment Post-Blink Movement- Right Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Number | percentage of eyes | Baseline and 1 week | Eyes | Eyes |
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| Primary | Clinician's Assessment Post-Blink Movement-Left Eye | Surveyed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week. Assessed immediately after the blink. (0-4, 0=insufficient, unacceptable movement, 1=minimal, but acceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Number | percentage of eyes | Baseline and 1 week | Eyes | Eyes |
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| Primary | Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye | Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees. | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Number | percentage of eyes | Baseline and 1 week | Eyes | Eyes |
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| Primary | Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye | Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Nasal mislocation is recorded as (+) and temporal as (-). Mislocation of the axis mark on the lens relative to the 6 o'clock position, zero rotation, measured in degrees. | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Number | percentage of eyes | Baseline and 1 week | Eyes | Eyes |
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| Primary | Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye | Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally. | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Mean | Standard Deviation | degrees | Baseline and 1 week | Eyes | Eyes |
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| Primary | Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye | Assessed for habitual pair at baseline. Dispensed pair after insertion/settling at 1 week . Slit lamp, with 10x magnification. Lens ability to return to its original position measured 60 seconds after manually rotating the lens 45 degrees temporally. | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Mean | Standard Deviation | degrees | Baseline and 1 week | Eyes | Eyes |
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| Primary | Participant's Subjective Rating for Overall Satisfaction - Comfort | Surveyed for each lens pair. Habitual pair at baseline. Dispensed pair at 1 week. Likert scale. (4 choices - completely satisfied, somewhat satisfied, somewhat dissatisfied, completely dissatisfied) | All 60 participants were analyzed for the habitual lenses. The results have been combined into a single arm "Habitual Lens" arm to create a single pair wise comparison to the, "Study Lens" arm. | Posted | Number | percentage of eyes | Baseline and 1 week | Eyes | Eyes |
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| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Ocufilcon D | Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation. enfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation. | 0 | 20 | 0 | 20 |
| EG002 | Methafilcon B | Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation. enfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation. | 0 | 20 | 0 | 20 |
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.
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| Dryness |
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| Handling |
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| Vision |
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| Lens Fit |
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| somewhat dissatisfied |
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| completely dissatisfied |
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| somewhat dissatisfied |
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| completely dissatisfied |
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| somewhat dissatisfied |
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| completely dissatisfied |
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| somewhat dissatisfied |
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| completely dissatisfied |
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| somewhat dissatisfied |
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| completely dissatisfied |
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| Moderate |
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| Good |
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| Excellent |
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| Moderate |
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| Good |
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| Excellent |
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| Moderate |
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| Good |
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| Excellent |
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| Moderate |
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| Good |
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| Excellent |
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| Substantially decentered |
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| Substantially decentered |
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| Optimal movement, |
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| Moderate, but acceptable movement |
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| Excessive, inacceptable movement |
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| Optimal movement |
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| Moderate, but acceptable movement |
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| Excessive,unacceptable movement |
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| Nasal |
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| Nasal |
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| somewhat dissatisfied |
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| completely dissatisfied |
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