Astigmatism
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEenfilcon A
Silicone hydrogel toric lenses.
Sponsors
CooperVision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
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 toric contact lens wearer * Has a contact lens spherical prescription between +6.00 to - 8.00 (inclusive) * Have no less than 0.75D of astigmatism and no more than 1.75 D in both eyes. * 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 (at least 5 days per week, \> 8 hours/day assuming there are no contraindications for doing so). * Is willing to comply with the visit schedule
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: * 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 Vision Stability at Insertion | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Night Vision Quality | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Lens Initial Comfort | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Lens Comfort Prior to Removal | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Overall Lens Comfort | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Dryness During the Day | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Dryness Prior to Removal | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Overall Dryness | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Lens Handling - Insertion | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Overall Lens Fit Stability | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Overall Vision Satisfaction | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Vision Quality at Insertion | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Vision Quality During the Day | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Vision Quality End of the Day | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Vision Stability During the Day | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Vision Stability at End of Day | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Lens Pair Preference | 1 week | 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. |
| Participant's Subjective Rating for Overall Satisfaction - Dryness | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Overall Satisfaction - Handling | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Overall Satisfaction - Vision | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Overall Satisfaction - Lens Fit | Baseline and 1 week | 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) |
| Participant's Subjective Rating for Overall Satisfaction - Overall | Baseline and 1 week | 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) |
| Clinician's Objective Assessment Monocular High Contrast Distance Visual | Baseline and 1 week | 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. |
| Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity | Baseline and 1 week | 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 |
| Clinician's Assessment Overall Lens Stability-Right Eye | Baseline and 1 week | 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) |
| Clinician's Assessment Overall Lens Stability-Left Eye | Baseline and 1 week | 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) |
| Clinician's Assessment Overall Fit Acceptance- Right Eye | Baseline and 1 week | 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) |
| Clinician's Assessment Overall Fit Acceptance- Left Eye | Baseline and 1 week | 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) |
| Clinician's Assessment Lens Centration-Right Eye | Baseline and 1 week | 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)) |
| Clinician's Assessment Lens Centration- Left Eye | Baseline and 1 week | 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) |
| Clinician's Assessment Corneal Coverage-Right Eye | Baseline and 1 week | 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) |
| Clinicians Assessment Corneal Coverage-Left Eye | Baseline and 1 week | 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) |
| Clinician's Assessment Post-Blink Movement- Right Eye | Baseline and 1 week | 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 |
| Clinician's Assessment Post-Blink Movement-Left Eye | Baseline and 1 week | 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 |
| Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye | Baseline and 1 week | 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. |
| Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye | Baseline and 1 week | 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. |
| Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye | Baseline and 1 week | 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. |
| Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye | Baseline and 1 week | 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. |
| Participant's Subjective Rating for Overall Satisfaction - Comfort | Baseline and 1 week | 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) |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 60 |
| Total | 60 |
Baseline characteristics
| Characteristic | Overall Study Group |
|---|---|
| Age, Continuous | 26 years STANDARD_DEVIATION 5.5 |
| Sex: Female, Male Female | 33 Participants |
| Sex: Female, Male Male | 27 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 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
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)
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Clinicians Assessment Corneal Coverage-Left Eye | Full corneal coverage | 100 percentage of eyes |
| Omafilcon A | Clinicians Assessment Corneal Coverage-Left Eye | Incomplete corneal coverage | 0 percentage of eyes |
| Ocufilcon D | Clinicians Assessment Corneal Coverage-Left Eye | Full corneal coverage | 100 percentage of eyes |
| Ocufilcon D | Clinicians Assessment Corneal Coverage-Left Eye | Incomplete corneal coverage | 0 percentage of eyes |
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)
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Clinician's Assessment Corneal Coverage-Right Eye | Full corneal coverage | 100 percentage of eyes |
| Omafilcon A | Clinician's Assessment Corneal Coverage-Right Eye | Incomplete corneal coverage | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Corneal Coverage-Right Eye | Full corneal coverage | 100 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Corneal Coverage-Right Eye | Incomplete corneal coverage | 0 percentage of eyes |
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)
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Clinician's Assessment Lens Centration- Left Eye | Centered | 100 percentage of eyes |
| Omafilcon A | Clinician's Assessment Lens Centration- Left Eye | Slightly decentered | 0 percentage of eyes |
| Omafilcon A | Clinician's Assessment Lens Centration- Left Eye | Substantially decentered | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Lens Centration- Left Eye | Centered | 100 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Lens Centration- Left Eye | Slightly decentered | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Lens Centration- Left Eye | Substantially decentered | 0 percentage of eyes |
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))
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Clinician's Assessment Lens Centration-Right Eye | Centered | 100 percentage of eyes |
| Omafilcon A | Clinician's Assessment Lens Centration-Right Eye | Slightly decentered | 0 percentage of eyes |
| Omafilcon A | Clinician's Assessment Lens Centration-Right Eye | Substantially decentered | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Lens Centration-Right Eye | Centered | 100 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Lens Centration-Right Eye | Slightly decentered | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Lens Centration-Right Eye | Substantially decentered | 0 percentage of eyes |
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.
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye | Temporal | 12 percentage of eyes |
| Omafilcon A | Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye | 0 rotation | 73 percentage of eyes |
| Omafilcon A | Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye | Nasal | 15 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye | Temporal | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye | 0 rotation | 100 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Lens Orientation in Primary Position of Gaze-Left Eye | Nasal | 0 percentage of eyes |
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.
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye | Temporal | 12 percentage of eyes |
| Omafilcon A | Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye | 0 rotation | 18 percentage of eyes |
| Omafilcon A | Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye | Nasal | 70 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye | Temporal | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye | 0 rotation | 100 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Lens Orientation in Primary Position of Gaze- Right Eye | Nasal | 0 percentage of eyes |
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)
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Clinician's Assessment Overall Fit Acceptance- Left Eye | Poor | 0 percentage of eyes |
| Omafilcon A | Clinician's Assessment Overall Fit Acceptance- Left Eye | Good | 48 percentage of eyes |
| Omafilcon A | Clinician's Assessment Overall Fit Acceptance- Left Eye | Moderate | 0 percentage of eyes |
| Omafilcon A | Clinician's Assessment Overall Fit Acceptance- Left Eye | Excellent | 52 percentage of eyes |
| Omafilcon A | Clinician's Assessment Overall Fit Acceptance- Left Eye | Very Poor | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Fit Acceptance- Left Eye | Excellent | 97 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Fit Acceptance- Left Eye | Very Poor | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Fit Acceptance- Left Eye | Poor | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Fit Acceptance- Left Eye | Moderate | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Fit Acceptance- Left Eye | Good | 3 percentage of eyes |
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)
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Clinician's Assessment Overall Fit Acceptance- Right Eye | Poor | 0 percentage of eyes |
| Omafilcon A | Clinician's Assessment Overall Fit Acceptance- Right Eye | Good | 48 percentage of eyes |
| Omafilcon A | Clinician's Assessment Overall Fit Acceptance- Right Eye | Moderate | 0 percentage of eyes |
| Omafilcon A | Clinician's Assessment Overall Fit Acceptance- Right Eye | Excellent | 52 percentage of eyes |
| Omafilcon A | Clinician's Assessment Overall Fit Acceptance- Right Eye | Very Poor | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Fit Acceptance- Right Eye | Excellent | 97 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Fit Acceptance- Right Eye | Very Poor | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Fit Acceptance- Right Eye | Poor | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Fit Acceptance- Right Eye | Moderate | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Fit Acceptance- Right Eye | Good | 3 percentage of eyes |
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)
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Clinician's Assessment Overall Lens Stability-Left Eye | Poor | 0 percentage of eyes |
| Omafilcon A | Clinician's Assessment Overall Lens Stability-Left Eye | Good | 55 percentage of eyes |
| Omafilcon A | Clinician's Assessment Overall Lens Stability-Left Eye | Moderate | 0 percentage of eyes |
| Omafilcon A | Clinician's Assessment Overall Lens Stability-Left Eye | Excellent | 45 percentage of eyes |
| Omafilcon A | Clinician's Assessment Overall Lens Stability-Left Eye | Very Poor | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Lens Stability-Left Eye | Excellent | 95 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Lens Stability-Left Eye | Very Poor | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Lens Stability-Left Eye | Poor | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Lens Stability-Left Eye | Moderate | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Lens Stability-Left Eye | Good | 5 percentage of eyes |
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)
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Clinician's Assessment Overall Lens Stability-Right Eye | Poor | 0 percentage of eyes |
| Omafilcon A | Clinician's Assessment Overall Lens Stability-Right Eye | Good | 62 percentage of eyes |
| Omafilcon A | Clinician's Assessment Overall Lens Stability-Right Eye | Moderate | 0 percentage of eyes |
| Omafilcon A | Clinician's Assessment Overall Lens Stability-Right Eye | Excellent | 38 percentage of eyes |
| Omafilcon A | Clinician's Assessment Overall Lens Stability-Right Eye | Very Poor | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Lens Stability-Right Eye | Excellent | 92 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Lens Stability-Right Eye | Very Poor | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Lens Stability-Right Eye | Poor | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Lens Stability-Right Eye | Moderate | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Overall Lens Stability-Right Eye | Good | 8 percentage of eyes |
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
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Clinician's Assessment Post-Blink Movement-Left Eye | Minimal, but acceptable movement | 0 percentage of eyes |
| Omafilcon A | Clinician's Assessment Post-Blink Movement-Left Eye | Moderate, but acceptable movement | 0 percentage of eyes |
| Omafilcon A | Clinician's Assessment Post-Blink Movement-Left Eye | Optimal movement | 100 percentage of eyes |
| Omafilcon A | Clinician's Assessment Post-Blink Movement-Left Eye | Excessive,unacceptable movement | 0 percentage of eyes |
| Omafilcon A | Clinician's Assessment Post-Blink Movement-Left Eye | Insufficient/Unacceptable movement | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Post-Blink Movement-Left Eye | Excessive,unacceptable movement | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Post-Blink Movement-Left Eye | Insufficient/Unacceptable movement | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Post-Blink Movement-Left Eye | Minimal, but acceptable movement | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Post-Blink Movement-Left Eye | Optimal movement | 100 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Post-Blink Movement-Left Eye | Moderate, but acceptable movement | 0 percentage of eyes |
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
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Clinician's Assessment Post-Blink Movement- Right Eye | Minimal, but acceptable movement | 0 percentage of eyes |
| Omafilcon A | Clinician's Assessment Post-Blink Movement- Right Eye | Moderate, but acceptable movement | 0 percentage of eyes |
| Omafilcon A | Clinician's Assessment Post-Blink Movement- Right Eye | Optimal movement, | 100 percentage of eyes |
| Omafilcon A | Clinician's Assessment Post-Blink Movement- Right Eye | Excessive, inacceptable movement | 0 percentage of eyes |
| Omafilcon A | Clinician's Assessment Post-Blink Movement- Right Eye | Insufficient/Unacceptable movement | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Post-Blink Movement- Right Eye | Excessive, inacceptable movement | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Post-Blink Movement- Right Eye | Insufficient/Unacceptable movement | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Post-Blink Movement- Right Eye | Minimal, but acceptable movement | 0 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Post-Blink Movement- Right Eye | Optimal movement, | 100 percentage of eyes |
| Ocufilcon D | Clinician's Assessment Post-Blink Movement- Right Eye | Moderate, but acceptable movement | 0 percentage of eyes |
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.
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omafilcon A | Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye | 0 degrees | Standard Deviation 0 |
| Ocufilcon D | Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Left Eye | 0 degrees | Standard Deviation 0 |
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.
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omafilcon A | Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye | 0 degrees | Standard Deviation 0 |
| Ocufilcon D | Clinician's Assessment Rotational Recovery in Degrees After 60 Seconds-Right Eye | 0 degrees | Standard Deviation 0 |
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
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Omafilcon A | Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity | -0.037 LogMAR | Standard Deviation 0.0049 |
| Ocufilcon D | Clinician's Objective Assessment Binocular High Contrast Distance Visual Acuity | -0.037 LogMAR | Standard Deviation 0.0049 |
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.
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Clinician's Objective Assessment Monocular High Contrast Distance Visual | VA Oculus Dexter (OD) | -0.037 LogMAR | Standard Deviation 0.049 |
| Omafilcon A | Clinician's Objective Assessment Monocular High Contrast Distance Visual | VA Oculus Sinister (OS) | -0.037 LogMAR | Standard Deviation 0.049 |
| Ocufilcon D | Clinician's Objective Assessment Monocular High Contrast Distance Visual | VA Oculus Dexter (OD) | -0.037 LogMAR | Standard Deviation 0.049 |
| Ocufilcon D | Clinician's Objective Assessment Monocular High Contrast Distance Visual | VA Oculus Sinister (OS) | -0.037 LogMAR | Standard Deviation 0.049 |
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)
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Dryness During the Day | Habitual lens-Baseline | 7.7 units on a scale | Standard Deviation 1.5 |
| Omafilcon A | Participant's Subjective Rating for Dryness During the Day | Study lens-1 week | 8.6 units on a scale | Standard Deviation 1.5 |
| Ocufilcon D | Participant's Subjective Rating for Dryness During the Day | Habitual lens-Baseline | 8.0 units on a scale | Standard Deviation 0.9 |
| Ocufilcon D | Participant's Subjective Rating for Dryness During the Day | Study lens-1 week | 8.1 units on a scale | Standard Deviation 1.6 |
| Methafilcon B | Participant's Subjective Rating for Dryness During the Day | Habitual lens-Baseline | 7.4 units on a scale | Standard Deviation 1.7 |
| Methafilcon B | Participant's Subjective Rating for Dryness During the Day | Study lens-1 week | 8.2 units on a scale | Standard Deviation 1.6 |
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)
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Dryness Prior to Removal | Habitual lens-Baseline | 7.4 units on a scale | Standard Deviation 1.4 |
| Omafilcon A | Participant's Subjective Rating for Dryness Prior to Removal | Study lens-1 week | 7.7 units on a scale | Standard Deviation 1.7 |
| Ocufilcon D | Participant's Subjective Rating for Dryness Prior to Removal | Habitual lens-Baseline | 7.0 units on a scale | Standard Deviation 1.3 |
| Ocufilcon D | Participant's Subjective Rating for Dryness Prior to Removal | Study lens-1 week | 7.5 units on a scale | Standard Deviation 1.9 |
| Methafilcon B | Participant's Subjective Rating for Dryness Prior to Removal | Habitual lens-Baseline | 6.3 units on a scale | Standard Deviation 2.2 |
| Methafilcon B | Participant's Subjective Rating for Dryness Prior to Removal | Study lens-1 week | 7.5 units on a scale | Standard Deviation 2.1 |
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)
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Lens Comfort Prior to Removal | Habitual lens -Baseline | 7.4 units on a scale | Standard Deviation 1.2 |
| Omafilcon A | Participant's Subjective Rating for Lens Comfort Prior to Removal | Study Lens -1 week | 8.2 units on a scale | Standard Deviation 1.4 |
| Ocufilcon D | Participant's Subjective Rating for Lens Comfort Prior to Removal | Habitual lens -Baseline | 7.4 units on a scale | Standard Deviation 1.7 |
| Ocufilcon D | Participant's Subjective Rating for Lens Comfort Prior to Removal | Study Lens -1 week | 8.0 units on a scale | Standard Deviation 1.4 |
| Methafilcon B | Participant's Subjective Rating for Lens Comfort Prior to Removal | Habitual lens -Baseline | 6.7 units on a scale | Standard Deviation 2 |
| Methafilcon B | Participant's Subjective Rating for Lens Comfort Prior to Removal | Study Lens -1 week | 7.3 units on a scale | Standard Deviation 2.3 |
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)
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Lens Handling - Insertion | Habitual lens-Baseline | 8.4 units on a scale | Standard Deviation 1.2 |
| Omafilcon A | Participant's Subjective Rating for Lens Handling - Insertion | Study lens-1 week | 9.3 units on a scale | Standard Deviation 0.7 |
| Ocufilcon D | Participant's Subjective Rating for Lens Handling - Insertion | Habitual lens-Baseline | 8.8 units on a scale | Standard Deviation 1.4 |
| Ocufilcon D | Participant's Subjective Rating for Lens Handling - Insertion | Study lens-1 week | 8.8 units on a scale | Standard Deviation 1 |
| Methafilcon B | Participant's Subjective Rating for Lens Handling - Insertion | Habitual lens-Baseline | 9.1 units on a scale | Standard Deviation 0.8 |
| Methafilcon B | Participant's Subjective Rating for Lens Handling - Insertion | Study lens-1 week | 9.5 units on a scale | Standard Deviation 0.9 |
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)
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Lens Initial Comfort | Habitual lens-Baseline | 6.9 units on a scale | Standard Deviation 1.4 |
| Omafilcon A | Participant's Subjective Rating for Lens Initial Comfort | Study lens-1 Week | 8.9 units on a scale | Standard Deviation 1.3 |
| Ocufilcon D | Participant's Subjective Rating for Lens Initial Comfort | Habitual lens-Baseline | 7.4 units on a scale | Standard Deviation 1.3 |
| Ocufilcon D | Participant's Subjective Rating for Lens Initial Comfort | Study lens-1 Week | 7.8 units on a scale | Standard Deviation 1.8 |
| Methafilcon B | Participant's Subjective Rating for Lens Initial Comfort | Habitual lens-Baseline | 8.0 units on a scale | Standard Deviation 1.1 |
| Methafilcon B | Participant's Subjective Rating for Lens Initial Comfort | Study lens-1 Week | 8.1 units on a scale | Standard Deviation 1.7 |
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.
Time frame: 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Lens Pair Preference | Handling | 17 Percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Lens Pair Preference | Comfort | 13 Percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Lens Pair Preference | Vision | 13 Percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Lens Pair Preference | Overall | 10 Percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Lens Pair Preference | Lens Fit | 10 Percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Lens Pair Preference | Dryness | 25 Percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Lens Pair Preference | Lens Fit | 90 Percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Lens Pair Preference | Overall | 90 Percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Lens Pair Preference | Comfort | 87 Percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Lens Pair Preference | Handling | 83 Percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Lens Pair Preference | Vision | 85 Percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Lens Pair Preference | Dryness | 75 Percentage of eyes |
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)
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Night Vision Quality | Habitual lens-Baseline | 77.3 units on a scale | Standard Deviation 7.2 |
| Omafilcon A | Participant's Subjective Rating for Night Vision Quality | Study lens-1 week | 83.5 units on a scale | Standard Deviation 8.6 |
| Ocufilcon D | Participant's Subjective Rating for Night Vision Quality | Habitual lens-Baseline | 83.3 units on a scale | Standard Deviation 10.5 |
| Ocufilcon D | Participant's Subjective Rating for Night Vision Quality | Study lens-1 week | 84.5 units on a scale | Standard Deviation 7.8 |
| Methafilcon B | Participant's Subjective Rating for Night Vision Quality | Habitual lens-Baseline | 81.8 units on a scale | Standard Deviation 10 |
| Methafilcon B | Participant's Subjective Rating for Night Vision Quality | Study lens-1 week | 87.3 units on a scale | Standard Deviation 8.7 |
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)
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Overall Dryness | Habitual lens-Baseline | 7.8 units on a scale | Standard Deviation 1.3 |
| Omafilcon A | Participant's Subjective Rating for Overall Dryness | Study lens-1 week | 8.8 units on a scale | Standard Deviation 1.2 |
| Ocufilcon D | Participant's Subjective Rating for Overall Dryness | Habitual lens-Baseline | 7.6 units on a scale | Standard Deviation 1 |
| Ocufilcon D | Participant's Subjective Rating for Overall Dryness | Study lens-1 week | 8.3 units on a scale | Standard Deviation 1.4 |
| Methafilcon B | Participant's Subjective Rating for Overall Dryness | Habitual lens-Baseline | 7.2 units on a scale | Standard Deviation 1.9 |
| Methafilcon B | Participant's Subjective Rating for Overall Dryness | Study lens-1 week | 8.2 units on a scale | Standard Deviation 1.7 |
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)
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Overall Lens Comfort | Habitual lens- Baseline | 8.2 units on a scale | Standard Deviation 1.1 |
| Omafilcon A | Participant's Subjective Rating for Overall Lens Comfort | Study lens-1 week | 8.8 units on a scale | Standard Deviation 1.1 |
| Ocufilcon D | Participant's Subjective Rating for Overall Lens Comfort | Habitual lens- Baseline | 8.4 units on a scale | Standard Deviation 1 |
| Ocufilcon D | Participant's Subjective Rating for Overall Lens Comfort | Study lens-1 week | 8.4 units on a scale | Standard Deviation 1.2 |
| Methafilcon B | Participant's Subjective Rating for Overall Lens Comfort | Habitual lens- Baseline | 8.2 units on a scale | Standard Deviation 1.2 |
| Methafilcon B | Participant's Subjective Rating for Overall Lens Comfort | Study lens-1 week | 8.4 units on a scale | Standard Deviation 1.4 |
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)
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Overall Lens Fit Stability | Habitual lens-Baseline | 8.1 units on a scale | Standard Deviation 1.3 |
| Omafilcon A | Participant's Subjective Rating for Overall Lens Fit Stability | Study Lens- 1 week | 8.1 units on a scale | Standard Deviation 1.8 |
| Ocufilcon D | Participant's Subjective Rating for Overall Lens Fit Stability | Habitual lens-Baseline | 7.8 units on a scale | Standard Deviation 1.5 |
| Ocufilcon D | Participant's Subjective Rating for Overall Lens Fit Stability | Study Lens- 1 week | 8.0 units on a scale | Standard Deviation 1.5 |
| Methafilcon B | Participant's Subjective Rating for Overall Lens Fit Stability | Habitual lens-Baseline | 7.9 units on a scale | Standard Deviation 1.7 |
| Methafilcon B | Participant's Subjective Rating for Overall Lens Fit Stability | Study Lens- 1 week | 9.0 units on a scale | Standard Deviation 0.8 |
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)
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Comfort | Completely satisfied | 30 percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Comfort | somewhat satisfied | 58 percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Comfort | somewhat dissatisfied | 12 percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Comfort | completely dissatisfied | 0 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Comfort | completely dissatisfied | 0 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Comfort | Completely satisfied | 55 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Comfort | somewhat dissatisfied | 5 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Comfort | somewhat satisfied | 40 percentage of eyes |
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)
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Dryness | completely satisfied | 27 percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Dryness | somewhat satisfied | 55 percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Dryness | somewhat dissatisfied | 18 percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Dryness | completely dissatisfied | 0 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Dryness | completely dissatisfied | 5 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Dryness | completely satisfied | 40 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Dryness | somewhat dissatisfied | 13 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Dryness | somewhat satisfied | 42 percentage of eyes |
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)
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Handling | completely satisfied | 73 percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Handling | somewhat satisfied | 23 percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Handling | somewhat dissatisfied | 3 percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Handling | completely dissatisfied | 0 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Handling | completely dissatisfied | 0 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Handling | completely satisfied | 87 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Handling | somewhat dissatisfied | 2 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Handling | somewhat satisfied | 12 percentage of eyes |
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)
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Lens Fit | completely satisfied | 40 percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Lens Fit | somewhat satisfied | 42 percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Lens Fit | somewhat dissatisfied | 18 percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Lens Fit | completely dissatisfied | 0 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Lens Fit | completely dissatisfied | 0 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Lens Fit | completely satisfied | 65 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Lens Fit | somewhat dissatisfied | 12 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Lens Fit | somewhat satisfied | 23 percentage of eyes |
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)
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Overall | completely satisfied | 30 percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Overall | somewhat dissatisfied | 3 percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Overall | somewhat satisfied | 67 percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Overall | completely dissatisfied | 0 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Overall | somewhat satisfied | 42 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Overall | completely satisfied | 58 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Overall | completely dissatisfied | 0 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Overall | somewhat dissatisfied | 0 percentage of eyes |
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)
Time frame: Baseline and 1 week
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Vision | completely satisfied | 48 percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Vision | somewhat satisfied | 43 percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Vision | somewhat dissatisfied | 8 percentage of eyes |
| Omafilcon A | Participant's Subjective Rating for Overall Satisfaction - Vision | completely dissatisfied | 0 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Vision | completely dissatisfied | 0 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Vision | completely satisfied | 62 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Vision | somewhat dissatisfied | 0 percentage of eyes |
| Ocufilcon D | Participant's Subjective Rating for Overall Satisfaction - Vision | somewhat satisfied | 37 percentage of eyes |
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)
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Overall Vision Satisfaction | Habitual lens- Baseline | 8.3 units on a scale | Standard Deviation 1.1 |
| Omafilcon A | Participant's Subjective Rating for Overall Vision Satisfaction | Study lens-1 week | 8.6 units on a scale | Standard Deviation 1.1 |
| Ocufilcon D | Participant's Subjective Rating for Overall Vision Satisfaction | Habitual lens- Baseline | 8.1 units on a scale | Standard Deviation 1.6 |
| Ocufilcon D | Participant's Subjective Rating for Overall Vision Satisfaction | Study lens-1 week | 8.7 units on a scale | Standard Deviation 1 |
| Methafilcon B | Participant's Subjective Rating for Overall Vision Satisfaction | Habitual lens- Baseline | 8.6 units on a scale | Standard Deviation 1.4 |
| Methafilcon B | Participant's Subjective Rating for Overall Vision Satisfaction | Study lens-1 week | 9.3 units on a scale | Standard Deviation 0.7 |
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)
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Vision Quality at Insertion | Habitual lens-Baseline | 77 units on a scale | Standard Deviation 10.3 |
| Omafilcon A | Participant's Subjective Rating for Vision Quality at Insertion | Study lens-1 week | 87.5 units on a scale | Standard Deviation 12.1 |
| Ocufilcon D | Participant's Subjective Rating for Vision Quality at Insertion | Habitual lens-Baseline | 75.5 units on a scale | Standard Deviation 11.9 |
| Ocufilcon D | Participant's Subjective Rating for Vision Quality at Insertion | Study lens-1 week | 82.5 units on a scale | Standard Deviation 12.5 |
| Methafilcon B | Participant's Subjective Rating for Vision Quality at Insertion | Habitual lens-Baseline | 79.5 units on a scale | Standard Deviation 10 |
| Methafilcon B | Participant's Subjective Rating for Vision Quality at Insertion | Study lens-1 week | 86.5 units on a scale | Standard Deviation 9.3 |
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)
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Vision Quality During the Day | Habitual lens-Baseline | 83 units on a scale | Standard Deviation 11.3 |
| Omafilcon A | Participant's Subjective Rating for Vision Quality During the Day | Study lens-1 week | 87.5 units on a scale | Standard Deviation 11.2 |
| Ocufilcon D | Participant's Subjective Rating for Vision Quality During the Day | Habitual lens-Baseline | 86 units on a scale | Standard Deviation 11 |
| Ocufilcon D | Participant's Subjective Rating for Vision Quality During the Day | Study lens-1 week | 85 units on a scale | Standard Deviation 8.9 |
| Methafilcon B | Participant's Subjective Rating for Vision Quality During the Day | Habitual lens-Baseline | 84.5 units on a scale | Standard Deviation 11.9 |
| Methafilcon B | Participant's Subjective Rating for Vision Quality During the Day | Study lens-1 week | 91.5 units on a scale | Standard Deviation 7.5 |
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)
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Vision Quality End of the Day | Habitual lens-Baseline | 79 units on a scale | Standard Deviation 10.2 |
| Omafilcon A | Participant's Subjective Rating for Vision Quality End of the Day | Study lens-1 week | 79.8 units on a scale | Standard Deviation 17.2 |
| Ocufilcon D | Participant's Subjective Rating for Vision Quality End of the Day | Habitual lens-Baseline | 82.5 units on a scale | Standard Deviation 14.1 |
| Ocufilcon D | Participant's Subjective Rating for Vision Quality End of the Day | Study lens-1 week | 80.5 units on a scale | Standard Deviation 13.9 |
| Methafilcon B | Participant's Subjective Rating for Vision Quality End of the Day | Habitual lens-Baseline | 76 units on a scale | Standard Deviation 14.1 |
| Methafilcon B | Participant's Subjective Rating for Vision Quality End of the Day | Study lens-1 week | 87.5 units on a scale | Standard Deviation 9.7 |
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)
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Vision Stability at End of Day | Habitual lens-Baseline | 81 units on a scale | Standard Deviation 9.1 |
| Omafilcon A | Participant's Subjective Rating for Vision Stability at End of Day | Study lens-1 week | 77.5 units on a scale | Standard Deviation 16.8 |
| Ocufilcon D | Participant's Subjective Rating for Vision Stability at End of Day | Habitual lens-Baseline | 79.5 units on a scale | Standard Deviation 13.9 |
| Ocufilcon D | Participant's Subjective Rating for Vision Stability at End of Day | Study lens-1 week | 82 units on a scale | Standard Deviation 13.2 |
| Methafilcon B | Participant's Subjective Rating for Vision Stability at End of Day | Habitual lens-Baseline | 75.5 units on a scale | Standard Deviation 16.4 |
| Methafilcon B | Participant's Subjective Rating for Vision Stability at End of Day | Study lens-1 week | 88.5 units on a scale | Standard Deviation 7.5 |
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)
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Vision Stability at Insertion | Habitual lenses-Baseline | 74 units on a scale | Standard Deviation 10.5 |
| Omafilcon A | Participant's Subjective Rating for Vision Stability at Insertion | Study lens-1 week | 86.5 units on a scale | Standard Deviation 11.4 |
| Ocufilcon D | Participant's Subjective Rating for Vision Stability at Insertion | Habitual lenses-Baseline | 70 units on a scale | Standard Deviation 12.6 |
| Ocufilcon D | Participant's Subjective Rating for Vision Stability at Insertion | Study lens-1 week | 81 units on a scale | Standard Deviation 14.1 |
| Methafilcon B | Participant's Subjective Rating for Vision Stability at Insertion | Habitual lenses-Baseline | 71.5 units on a scale | Standard Deviation 15.3 |
| Methafilcon B | Participant's Subjective Rating for Vision Stability at Insertion | Study lens-1 week | 85.5 units on a scale | Standard Deviation 10.5 |
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)
Time frame: Baseline and 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Omafilcon A | Participant's Subjective Rating for Vision Stability During the Day | Habitual lens-Baseline | 83 units on a scale | Standard Deviation 8.6 |
| Omafilcon A | Participant's Subjective Rating for Vision Stability During the Day | Study lens-1 week | 82.5 units on a scale | Standard Deviation 11.6 |
| Ocufilcon D | Participant's Subjective Rating for Vision Stability During the Day | Habitual lens-Baseline | 81.5 units on a scale | Standard Deviation 10.9 |
| Ocufilcon D | Participant's Subjective Rating for Vision Stability During the Day | Study lens-1 week | 82.5 units on a scale | Standard Deviation 12.1 |
| Methafilcon B | Participant's Subjective Rating for Vision Stability During the Day | Habitual lens-Baseline | 77.5 units on a scale | Standard Deviation 16.2 |
| Methafilcon B | Participant's Subjective Rating for Vision Stability During the Day | Study lens-1 week | 90 units on a scale | Standard Deviation 7.9 |