Myopia
Conditions
Brief summary
This study investigated the performance criteria over one week of daily wear to determine if the comfilcon A asphere lens (test) performed equivalently to the comfilcon A sphere (control) in terms of measurement and subjective ratings of visual performance.
Detailed description
This study was a prospective, single site, daily wear, double masked, randomized bilateral cross over dispensing study of binocular wear of comfilcon A asphere lens (test) and comfilcon A sphere lens (control) over 1 week of daily wear.
Interventions
DEVICEPhenacite
contact lens
DEVICEcomfilcon A
contact lens
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
A person is eligible for inclusion in the study if he/she: * Oculo-visual examination in the last two years * Between 18 and 35 years of age and has full legal capacity to volunteer * Has read and understood the informed consent letter * Is willing and able to follow instructions and maintain the appointment schedule * Is correctable to a visual acuity of 20/25 or better (in each eye) with their habitual correction or 20/20 best corrected * Currently wears, or has previously successfully worn, soft contact lenses between -1.00D (Diopoter) and -4.00D * Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder \<-0.75 * Has not worn lenses for at least 12 hours before the initial visit * Has a subjective response at baseline, which indicates suitability for this study * Currently spends a minimum of 4 hours a day; 5 days a week on digital devices and can replicate this time during the study period * Is willing and able to wear the study contact lenses a minimum of 10 hours per day; 5 days a week
Exclusion criteria
A person will be excluded from the study if he/she: * Has never worn contact lenses before * Any systemic disease affecting ocular health * Is using any systemic or topical medications that will affect ocular health * Has known sensitivity to the diagnostic pharmaceuticals or study products used in this study. * Has any ocular pathology or anomaly that would affect the wearing of the lenses * Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye * Is aphakic * Has anisometropia of \>1.00 * Has undergone corneal refractive surgery * Has strabismus * Has any ocular amblyopia \>= 1line of HC (High Contrast) Visual Acuity * Is participating in any other type of eye related clinical or research study * Has previously participated in study of the Phenacite lenses
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance Visual Acuity (VA) - High Illumination | Baseline (after 10 minutes of lens dispense) | Distance visual acuity High Illumination was assessed using logMAR |
| Near Visual Acuity (VA) - High Illumination | Baseline (after 10 minutes of lens dispense) | Near Visual Acuity (VA) - High Illumination assessed using logMAR |
| Distance Visual Acuity (VA) - Low Illumination | Baseline (after 10 minutes of lens dispense) | Distance Visual Acuity (VA) - Low Illumination assessed using logMAR |
| Near Visual Acuity (VA) - Low Illumination | Baseline (after 10 minutes of lens dispense) | Near Visual Acuity (VA) - Low illumination assessed using logMAR |
| Quality of Distance Vision | Baseline (after 10 minutes of lens dispense) | Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) |
| Quality of Near Vision | Baseline (After 10 minutes of lens dispense) | Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time |
| Quality of Vision With Digital Device Use | Baseline (After 10 minutes of lens dispense) | Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) |
| Quality of Intermediate Vision | Baseline (After 10 minutes of lens dispense) | Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) |
| Overall Vision Quality | Baseline (After 10 minutes of lens dispense) | Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Ratings of Change in Severity of Tiredness | 1 week | Subjective rating of change in eye fatigue severity of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG) |
| Subjective Ratings of Change in Bothersome Rating for Tiredness | 1 week | Subjective rating of change in eye fatigue bothersome rating for tiredness assessed using Eye fatigue Experience Questionnaire (EFEG) |
| Subjective Ratings of Change in Frequency of Dryness | 1 week | Subjective rating of change in eye fatigue frequency of dryness assessed using Eye fatigue Experience Questionnaire (EFEG) |
| Subjective Ratings of Change in Severity of Dryness | 1 week | Subjective rating of change in eye fatigue severity of dryness assessed using Eye fatigue Experience Questionnaire (EFEG) |
| Subjective Ratings of Change in Bothersome Rating of Dryness | 1 week | Subjective rating of change in eye fatigue bothersome rating for dryness assessed using Eye fatigue Experience Questionnaire (EFEG) |
| Biomicroscopy Findings - Bulbar Hyperemia | 1 week | Bulbar hyperemia assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps) |
| Subjective Questionnaire Response - Eye Feel Good | 1 week | Subjective questionnaire response for These lenses make my eyes feel good - Agree, Disagree |
| Subjective Questionnaire Response - Eye Feel Relaxed | 1 week | Subjective questionnaire response for These lenses make my eyes feel relaxed - Agree, Disagree |
| Subjective Questionnaire Response - Vision | 1 week | Subjective questionnaire response for These lenses help my vision - Agree, Disagree |
| Subjective Questionnaire Response - Eye Tired | 1 week | Subjective questionnaire response for These lenses make my eyes feel less tired - Agree, Disagree |
| Subjective Questionnaire Response - Eye Strain | 1 week | Subjective questionnaire response for My eyes don't feel strained while wearing these lenses - Agree, Disagree |
| Biomicroscopy Findings- Limbal Hyperemia | 1 week | Investigator assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps) |
| Biomicroscopy Findings - Corneal Staining Extent | 1 week | Investigator Assessment on Biomicroscopy Findings - Corneal Staining Extent on a scale of 0-4 : 0=No staining, 1=1-15% of area, 2=16-30% of area, 3=31-45% of area, 4= \>45% of area |
| Ghosting - Distance Vision | 1 week | Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable |
| Ghosting - Near Vision | 1 week | Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable |
| Overall Comfort | Baseline (After 10 minutes of lens dispense) | Patient subjective scoring using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever. |
| Overall Dryness | Baseline (after 10 minutes of lens dispense) | Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time. |
| Lens Preference - Overall Vision Preference | 1 week | Subjective rating of lens preference for overall vision preference (Phenacite, comfilcon A, No preference) |
| Subjective Ratings of Change in Frequency of Tiredness | 1 week | Subjective rating of change in eye fatigue frequency of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG) |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Subjects were randomized to wear phenacite study lens and comfilcon A control lens for one week. | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 44 Participants | — |
| Age, Continuous | 23.1 years STANDARD_DEVIATION 3.5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Canada | 16 participants | — |
| Region of Enrollment United States | 28 participants | — |
| Sex: Female, Male Female | 34 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 44 | 0 / 44 |
| other Total, other adverse events | 0 / 44 | 0 / 44 |
| serious Total, serious adverse events | 0 / 44 | 0 / 44 |
Outcome results
Primary
Distance Visual Acuity (VA) - High Illumination
Distance visual acuity High Illumination was assessed using logMAR
Time frame: 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite Test Lens | Distance Visual Acuity (VA) - High Illumination | Monocular | -0.10 logMAR | Standard Deviation 0.08 |
| Phenacite Test Lens | Distance Visual Acuity (VA) - High Illumination | Binocular | -0.15 logMAR | Standard Deviation 0.07 |
| Comfilcon A Control Lens | Distance Visual Acuity (VA) - High Illumination | Monocular | -0.11 logMAR | Standard Deviation 0.08 |
| Comfilcon A Control Lens | Distance Visual Acuity (VA) - High Illumination | Binocular | -0.16 logMAR | Standard Deviation 0.06 |
Primary
Distance Visual Acuity (VA) - High Illumination
Distance visual acuity High Illumination was assessed using logMAR
Time frame: Baseline (after 10 minutes of lens dispense)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite Test Lens | Distance Visual Acuity (VA) - High Illumination | Monocular | -0.10 logMAR | Standard Deviation 0.07 |
| Phenacite Test Lens | Distance Visual Acuity (VA) - High Illumination | Binocular | -0.15 logMAR | Standard Deviation 0.06 |
| Comfilcon A Control Lens | Distance Visual Acuity (VA) - High Illumination | Monocular | -0.11 logMAR | Standard Deviation 0.08 |
| Comfilcon A Control Lens | Distance Visual Acuity (VA) - High Illumination | Binocular | -0.17 logMAR | Standard Deviation 0.07 |
Primary
Distance Visual Acuity (VA) - Low Illumination
Distance Visual Acuity (VA) - Low Illumination assessed using logMAR
Time frame: 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite Test Lens | Distance Visual Acuity (VA) - Low Illumination | Monocular | 0.06 logMAR | Standard Deviation 0.08 |
| Phenacite Test Lens | Distance Visual Acuity (VA) - Low Illumination | Binocular | -0.01 logMAR | Standard Deviation 0.06 |
| Comfilcon A Control Lens | Distance Visual Acuity (VA) - Low Illumination | Monocular | 0.05 logMAR | Standard Deviation 0.1 |
| Comfilcon A Control Lens | Distance Visual Acuity (VA) - Low Illumination | Binocular | 0.01 logMAR | Standard Deviation 0.07 |
Primary
Distance Visual Acuity (VA) - Low Illumination
Distance Visual Acuity (VA) - Low Illumination assessed using logMAR
Time frame: Baseline (after 10 minutes of lens dispense)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite Test Lens | Distance Visual Acuity (VA) - Low Illumination | Monocular | 0.07 logMAR | Standard Deviation 0.08 |
| Phenacite Test Lens | Distance Visual Acuity (VA) - Low Illumination | Binocular | 0.02 logMAR | Standard Deviation 0.06 |
| Comfilcon A Control Lens | Distance Visual Acuity (VA) - Low Illumination | Monocular | 0.05 logMAR | Standard Deviation 0.08 |
| Comfilcon A Control Lens | Distance Visual Acuity (VA) - Low Illumination | Binocular | 0.00 logMAR | Standard Deviation 0.06 |
Primary
Near Visual Acuity (VA) - High Illumination
Near Visual Acuity (VA) - High Illumination assessed using logMAR
Time frame: Baseline (after 10 minutes of lens dispense)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite Test Lens | Near Visual Acuity (VA) - High Illumination | Monocular | -0.07 logMAR | Standard Deviation 0.09 |
| Phenacite Test Lens | Near Visual Acuity (VA) - High Illumination | Binocular | -0.13 logMAR | Standard Deviation 0.09 |
| Comfilcon A Control Lens | Near Visual Acuity (VA) - High Illumination | Monocular | -0.08 logMAR | Standard Deviation 0.08 |
| Comfilcon A Control Lens | Near Visual Acuity (VA) - High Illumination | Binocular | -0.14 logMAR | Standard Deviation 0.08 |
Primary
Near Visual Acuity (VA) - High Illumination
Near Visual Acuity (VA) - High Illumination assessed using logMAR
Time frame: 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite Test Lens | Near Visual Acuity (VA) - High Illumination | Monocular | -0.06 logMAR | Standard Deviation 0.1 |
| Phenacite Test Lens | Near Visual Acuity (VA) - High Illumination | Binocular | -0.11 logMAR | Standard Deviation 0.09 |
| Comfilcon A Control Lens | Near Visual Acuity (VA) - High Illumination | Monocular | -0.07 logMAR | Standard Deviation 0.09 |
| Comfilcon A Control Lens | Near Visual Acuity (VA) - High Illumination | Binocular | -0.13 logMAR | Standard Deviation 0.1 |
Primary
Near Visual Acuity (VA) - Low Illumination
Near Visual Acuity (VA) - Low illumination assessed using logMAR
Time frame: 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite Test Lens | Near Visual Acuity (VA) - Low Illumination | Monocular | 0.16 logMAR | Standard Deviation 0.17 |
| Phenacite Test Lens | Near Visual Acuity (VA) - Low Illumination | Binocular | 0.09 logMAR | Standard Deviation 0.16 |
| Comfilcon A Control Lens | Near Visual Acuity (VA) - Low Illumination | Monocular | 0.18 logMAR | Standard Deviation 0.17 |
| Comfilcon A Control Lens | Near Visual Acuity (VA) - Low Illumination | Binocular | 0.11 logMAR | Standard Deviation 0.17 |
Primary
Near Visual Acuity (VA) - Low Illumination
Near Visual Acuity (VA) - Low illumination assessed using logMAR
Time frame: Baseline (after 10 minutes of lens dispense)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite Test Lens | Near Visual Acuity (VA) - Low Illumination | Monocular | 0.15 logMAR | Standard Deviation 0.16 |
| Phenacite Test Lens | Near Visual Acuity (VA) - Low Illumination | Binocular | 0.10 logMAR | Standard Deviation 0.16 |
| Comfilcon A Control Lens | Near Visual Acuity (VA) - Low Illumination | Monocular | 0.14 logMAR | Standard Deviation 0.15 |
| Comfilcon A Control Lens | Near Visual Acuity (VA) - Low Illumination | Binocular | 0.08 logMAR | Standard Deviation 0.15 |
Primary
Overall Vision Quality
Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite Test Lens | Overall Vision Quality | 88 units on a scale | Standard Deviation 15 |
| Comfilcon A Control Lens | Overall Vision Quality | 89 units on a scale | Standard Deviation 12 |
Primary
Overall Vision Quality
Subjective scoring of overall vision quality assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time frame: Baseline (After 10 minutes of lens dispense)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite Test Lens | Overall Vision Quality | 95 units on a scale | Standard Deviation 6 |
| Comfilcon A Control Lens | Overall Vision Quality | 89 units on a scale | Standard Deviation 13 |
Primary
Quality of Distance Vision
Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time frame: Baseline (after 10 minutes of lens dispense)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite Test Lens | Quality of Distance Vision | 91 units on a scale | Standard Deviation 9 |
| Comfilcon A Control Lens | Quality of Distance Vision | 88 units on a scale | Standard Deviation 15 |
Primary
Quality of Distance Vision
Subjective scoring of Quality of Distance Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite Test Lens | Quality of Distance Vision | 87 units on a scale | Standard Deviation 16 |
| Comfilcon A Control Lens | Quality of Distance Vision | 90 units on a scale | Standard Deviation 12 |
Primary
Quality of Intermediate Vision
Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time frame: Baseline (After 10 minutes of lens dispense)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite Test Lens | Quality of Intermediate Vision | 97 units on a scale | Standard Deviation 6 |
| Comfilcon A Control Lens | Quality of Intermediate Vision | 93 units on a scale | Standard Deviation 9 |
Primary
Quality of Intermediate Vision
Subjective scoring of Quality of Intermediate Vision assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite Test Lens | Quality of Intermediate Vision | 92 units on a scale | Standard Deviation 11 |
| Comfilcon A Control Lens | Quality of Intermediate Vision | 92 units on a scale | Standard Deviation 10 |
Primary
Quality of Near Vision
Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite Test Lens | Quality of Near Vision | 90 units on a scale | Standard Deviation 12 |
| Comfilcon A Control Lens | Quality of Near Vision | 90 units on a scale | Standard Deviation 12 |
Primary
Quality of Near Vision
Patient subjective scoring for quality of near vision using 0-100 continuous scale: 0=extremely poor vision all of the time. 100=excellent vision all of the time
Time frame: Baseline (After 10 minutes of lens dispense)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite Test Lens | Quality of Near Vision | 94 units on a scale | Standard Deviation 8 |
| Comfilcon A Control Lens | Quality of Near Vision | 91 units on a scale | Standard Deviation 11 |
Primary
Quality of Vision With Digital Device Use
Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time frame: Baseline (After 10 minutes of lens dispense)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite Test Lens | Quality of Vision With Digital Device Use | 96 units on a scale | Standard Deviation 8 |
| Comfilcon A Control Lens | Quality of Vision With Digital Device Use | 94 units on a scale | Standard Deviation 7 |
Primary
Quality of Vision With Digital Device Use
Subjective scoring of Quality of Vision with digital device use assessed using 0-100 continuous scale: (0=extremely poor vision all of the time. 100=excellent vision all of the time)
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite Test Lens | Quality of Vision With Digital Device Use | 91 units on a scale | Standard Deviation 13 |
| Comfilcon A Control Lens | Quality of Vision With Digital Device Use | 90 units on a scale | Standard Deviation 12 |
Secondary
Biomicroscopy Findings - Bulbar Hyperemia
Bulbar hyperemia assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite Test Lens | Biomicroscopy Findings - Bulbar Hyperemia | 1.24 units on a scale | Standard Deviation 0.67 |
| Comfilcon A Control Lens | Biomicroscopy Findings - Bulbar Hyperemia | 1.37 units on a scale | Standard Deviation 0.82 |
Secondary
Biomicroscopy Findings - Corneal Staining Extent
Investigator Assessment on Biomicroscopy Findings - Corneal Staining Extent on a scale of 0-4 : 0=No staining, 1=1-15% of area, 2=16-30% of area, 3=31-45% of area, 4= \>45% of area
Time frame: 1 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite Test Lens | Biomicroscopy Findings - Corneal Staining Extent | Nasal | 0.14 units on a scale | Standard Deviation 0.34 |
| Phenacite Test Lens | Biomicroscopy Findings - Corneal Staining Extent | Superior | 0.13 units on a scale | Standard Deviation 0.37 |
| Phenacite Test Lens | Biomicroscopy Findings - Corneal Staining Extent | Temporal | 0.07 units on a scale | Standard Deviation 0.26 |
| Phenacite Test Lens | Biomicroscopy Findings - Corneal Staining Extent | Inferior | 0.34 units on a scale | Standard Deviation 0.58 |
| Phenacite Test Lens | Biomicroscopy Findings - Corneal Staining Extent | Central | 0.05 units on a scale | Standard Deviation 0.21 |
| Comfilcon A Control Lens | Biomicroscopy Findings - Corneal Staining Extent | Inferior | 0.51 units on a scale | Standard Deviation 0.74 |
| Comfilcon A Control Lens | Biomicroscopy Findings - Corneal Staining Extent | Central | 0.10 units on a scale | Standard Deviation 0.34 |
| Comfilcon A Control Lens | Biomicroscopy Findings - Corneal Staining Extent | Nasal | 0.16 units on a scale | Standard Deviation 0.39 |
| Comfilcon A Control Lens | Biomicroscopy Findings - Corneal Staining Extent | Temporal | 0.03 units on a scale | Standard Deviation 0.2 |
| Comfilcon A Control Lens | Biomicroscopy Findings - Corneal Staining Extent | Superior | 0.19 units on a scale | Standard Deviation 0.4 |
Secondary
Biomicroscopy Findings- Limbal Hyperemia
Investigator assessment using 5 categories: (0=None, 1= Slight injection to conjunctival vessels, 2= Mild injection, 3= Moderate injection, 4= Severe injection) in (0.25 steps)
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite Test Lens | Biomicroscopy Findings- Limbal Hyperemia | 0.98 units on a scale | Standard Deviation 0.69 |
| Comfilcon A Control Lens | Biomicroscopy Findings- Limbal Hyperemia | 1.21 units on a scale | Standard Deviation 0.89 |
Secondary
Ghosting - Distance Vision
Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite Test Lens | Ghosting - Distance Vision | 93 units on a scale | Standard Deviation 12 |
| Comfilcon A Control Lens | Ghosting - Distance Vision | 93 units on a scale | Standard Deviation 12 |
Secondary
Ghosting - Near Vision
Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite Test Lens | Ghosting - Near Vision | 93 units on a scale | Standard Deviation 10 |
| Comfilcon A Control Lens | Ghosting - Near Vision | 93 units on a scale | Standard Deviation 10 |
Secondary
Lens Preference - Overall Vision Preference
Subjective rating of lens preference for overall vision preference (Phenacite, comfilcon A, No preference)
Time frame: 1 week
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Phenacite Test Lens | Lens Preference - Overall Vision Preference | Phenacite | 14 Participants |
| Phenacite Test Lens | Lens Preference - Overall Vision Preference | comfilcon A | 25 Participants |
| Phenacite Test Lens | Lens Preference - Overall Vision Preference | No Preference | 5 Participants |
Secondary
Overall Comfort
Patient subjective scoring using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.
Time frame: Baseline (After 10 minutes of lens dispense)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite Test Lens | Overall Comfort | 91 units on a scale | Standard Deviation 8 |
| Comfilcon A Control Lens | Overall Comfort | 89 units on a scale | Standard Deviation 12 |
Secondary
Overall Comfort
Patient subjective scoring for overall comfort using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite Test Lens | Overall Comfort | 78 units on a scale | Standard Deviation 23 |
| Comfilcon A Control Lens | Overall Comfort | 79 units on a scale | Standard Deviation 19 |
Secondary
Overall Dryness
Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.
Time frame: Baseline (after 10 minutes of lens dispense)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite Test Lens | Overall Dryness | 92 units on a scale | Standard Deviation 12 |
| Comfilcon A Control Lens | Overall Dryness | 92 units on a scale | Standard Deviation 12 |
Secondary
Overall Dryness
Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite Test Lens | Overall Dryness | 76 units on a scale | Standard Deviation 23 |
| Comfilcon A Control Lens | Overall Dryness | 77 units on a scale | Standard Deviation 21 |
Secondary
Subjective Questionnaire Response - Eye Feel Good
Subjective questionnaire response for These lenses make my eyes feel good - Agree, Disagree
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phenacite Test Lens | Subjective Questionnaire Response - Eye Feel Good | Agree | 86 percentage of participants |
| Phenacite Test Lens | Subjective Questionnaire Response - Eye Feel Good | Disagree | 14 percentage of participants |
| Comfilcon A Control Lens | Subjective Questionnaire Response - Eye Feel Good | Disagree | 29 percentage of participants |
| Comfilcon A Control Lens | Subjective Questionnaire Response - Eye Feel Good | Agree | 71 percentage of participants |
Secondary
Subjective Questionnaire Response - Eye Feel Relaxed
Subjective questionnaire response for These lenses make my eyes feel relaxed - Agree, Disagree
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phenacite Test Lens | Subjective Questionnaire Response - Eye Feel Relaxed | Agree | 79 percentage of participants |
| Phenacite Test Lens | Subjective Questionnaire Response - Eye Feel Relaxed | Disagree | 21 percentage of participants |
| Comfilcon A Control Lens | Subjective Questionnaire Response - Eye Feel Relaxed | Agree | 79 percentage of participants |
| Comfilcon A Control Lens | Subjective Questionnaire Response - Eye Feel Relaxed | Disagree | 21 percentage of participants |
Secondary
Subjective Questionnaire Response - Eye Strain
Subjective questionnaire response for My eyes don't feel strained while wearing these lenses - Agree, Disagree
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phenacite Test Lens | Subjective Questionnaire Response - Eye Strain | Agree | 75 percentage of participants |
| Phenacite Test Lens | Subjective Questionnaire Response - Eye Strain | Disagree | 25 percentage of participants |
| Comfilcon A Control Lens | Subjective Questionnaire Response - Eye Strain | Agree | 75 percentage of participants |
| Comfilcon A Control Lens | Subjective Questionnaire Response - Eye Strain | Disagree | 25 percentage of participants |
Secondary
Subjective Questionnaire Response - Eye Tired
Subjective questionnaire response for These lenses make my eyes feel less tired - Agree, Disagree
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phenacite Test Lens | Subjective Questionnaire Response - Eye Tired | Agree | 82 percentage of participants |
| Phenacite Test Lens | Subjective Questionnaire Response - Eye Tired | Disagree | 18 percentage of participants |
| Comfilcon A Control Lens | Subjective Questionnaire Response - Eye Tired | Agree | 75 percentage of participants |
| Comfilcon A Control Lens | Subjective Questionnaire Response - Eye Tired | Disagree | 25 percentage of participants |
Secondary
Subjective Questionnaire Response - Vision
Subjective questionnaire response for These lenses help my vision - Agree, Disagree
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phenacite Test Lens | Subjective Questionnaire Response - Vision | Agree | 96 percentage of participants |
| Phenacite Test Lens | Subjective Questionnaire Response - Vision | Disagree | 4 percentage of participants |
| Comfilcon A Control Lens | Subjective Questionnaire Response - Vision | Agree | 96 percentage of participants |
| Comfilcon A Control Lens | Subjective Questionnaire Response - Vision | Disagree | 4 percentage of participants |
Secondary
Subjective Ratings of Change in Bothersome Rating for Tiredness
Subjective rating of change in eye fatigue bothersome rating for tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phenacite Test Lens | Subjective Ratings of Change in Bothersome Rating for Tiredness | Much Better | 20 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Bothersome Rating for Tiredness | Worse | 0 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Bothersome Rating for Tiredness | No Difference | 35 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Bothersome Rating for Tiredness | Much Worse | 0 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Bothersome Rating for Tiredness | Better | 45 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Bothersome Rating for Tiredness | Much Worse | 0 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Bothersome Rating for Tiredness | Better | 45 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Bothersome Rating for Tiredness | Much Better | 10 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Bothersome Rating for Tiredness | No Difference | 40 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Bothersome Rating for Tiredness | Worse | 5 percentage of participants |
Secondary
Subjective Ratings of Change in Bothersome Rating of Dryness
Subjective rating of change in eye fatigue bothersome rating for dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phenacite Test Lens | Subjective Ratings of Change in Bothersome Rating of Dryness | Better | 40 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Bothersome Rating of Dryness | Worse | 15 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Bothersome Rating of Dryness | No Difference | 25 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Bothersome Rating of Dryness | Much Worse | 5 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Bothersome Rating of Dryness | Much Better | 15 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Bothersome Rating of Dryness | Much Worse | 5 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Bothersome Rating of Dryness | Much Better | 10 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Bothersome Rating of Dryness | Better | 40 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Bothersome Rating of Dryness | No Difference | 25 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Bothersome Rating of Dryness | Worse | 20 percentage of participants |
Secondary
Subjective Ratings of Change in Frequency of Dryness
Subjective rating of change in eye fatigue frequency of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phenacite Test Lens | Subjective Ratings of Change in Frequency of Dryness | No Difference | 25 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Frequency of Dryness | Worse | 15 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Frequency of Dryness | Much Better | 15 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Frequency of Dryness | Much Worse | 10 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Frequency of Dryness | Better | 35 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Frequency of Dryness | Much Worse | 5 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Frequency of Dryness | Better | 15 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Frequency of Dryness | No Difference | 35 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Frequency of Dryness | Worse | 25 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Frequency of Dryness | Much Better | 20 percentage of participants |
Secondary
Subjective Ratings of Change in Frequency of Tiredness
Subjective rating of change in eye fatigue frequency of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phenacite Test Lens | Subjective Ratings of Change in Frequency of Tiredness | Better | 50 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Frequency of Tiredness | Worse | 0 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Frequency of Tiredness | No Difference | 36 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Frequency of Tiredness | Much Worse | 4 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Frequency of Tiredness | Much Better | 11 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Frequency of Tiredness | Much Worse | 0 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Frequency of Tiredness | Much Better | 18 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Frequency of Tiredness | Better | 39 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Frequency of Tiredness | No Difference | 39 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Frequency of Tiredness | Worse | 4 percentage of participants |
Secondary
Subjective Ratings of Change in Severity of Dryness
Subjective rating of change in eye fatigue severity of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phenacite Test Lens | Subjective Ratings of Change in Severity of Dryness | Better | 41 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Severity of Dryness | Worse | 9 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Severity of Dryness | No Difference | 32 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Severity of Dryness | Much Worse | 9 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Severity of Dryness | Much Better | 9 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Severity of Dryness | Much Worse | 5 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Severity of Dryness | Much Better | 5 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Severity of Dryness | Better | 41 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Severity of Dryness | No Difference | 27 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Severity of Dryness | Worse | 23 percentage of participants |
Secondary
Subjective Ratings of Change in Severity of Tiredness
Subjective rating of change in eye fatigue severity of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phenacite Test Lens | Subjective Ratings of Change in Severity of Tiredness | Better | 48 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Severity of Tiredness | Worse | 4 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Severity of Tiredness | No Difference | 26 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Severity of Tiredness | Much Worse | 4 percentage of participants |
| Phenacite Test Lens | Subjective Ratings of Change in Severity of Tiredness | Much Better | 17 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Severity of Tiredness | Much Worse | 0 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Severity of Tiredness | Much Better | 17 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Severity of Tiredness | Better | 39 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Severity of Tiredness | No Difference | 35 percentage of participants |
| Comfilcon A Control Lens | Subjective Ratings of Change in Severity of Tiredness | Worse | 9 percentage of participants |