Ametropia
Conditions
Brief summary
Dispensing Study for the Phenacite Project. The investigational test lens was not the final optical design and the study was not used for design validation.
Detailed description
Evaluate the objective and patient-reported visual acceptability of the Phenacite contact lens.
Interventions
DEVICEPhenacite
Subjects will be randomized to wear the Phenacite contact lenses binocularly.
DEVICEcomfilcon A
Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
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
* 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 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
* 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 Visual Acuity * Is participating in any other type of eye related clinical or research study * Has participated in study CV-14-32.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Ratings of Lens Comfort | Baseline (after 15 minutes of lens dispense) | Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt) |
| Over Refraction for Optimized Distance Acuity | 2 weeks | Over Refraction for optimized distance acuity measured using logMAR |
| Binocular Distance Visual Acuity - High Illumination High Contrast | Baseline (after 5 minutes of lens dispense) | Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR |
| Binocular Distance Visual Acuity - Low Illumination High Contrast | Baseline (after 5 minutes of lens dispense) | Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR |
| Binocular Near Visual Acuity - High Illumination High Contrast | Baseline (after 5 minutes of lens dispense) | Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR |
| Binocular Near Visual Acuity - Low Illumination High Contrast | Baseline (after 5 minutes of lens dispense) | Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subjective Ratings for Vision Quality - Computer Vision | Baseline (after 15 minutes of lens dispense) | Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time |
| Subjective Ratings for Vision Quality - Overall Vision | Baseline (after 15 minutes of lens dispense) | Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time |
| Lens Fit - Post Blink Movement | Baseline (after 15 minutes of lens dispense) | Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps) |
| Conjunctival Staining | 2 weeks | Conjunctival staining was assessed on a scale of 0-4, 0.50 steps (0-None, 1 - Minimal diffuse punctuate, 2- Coalescent Punctuate, 3- confluent, 4- Deep confluent |
| Corneal Staining Extent | 2 weeks | Corneal staining extent was assessed 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 |
| Push - Up Test for Lens Tightness | Baseline (after 15 minutes of lens dispense) | Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement |
| Lens Mobility Rating | Baseline (after 15 minutes of lens dispense) | Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (\>1mm) on versions in all directions in 0.25 steps |
| Overall Lens Fit Acceptance | Baseline (after 15 minutes of lens dispense) | Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps |
| Subjective Ratings for Vision Quality - Distance Vision | Baseline (after 15 minutes of lens dispense) | Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time |
| Subjective Ratings for Vision Quality - Near Vision | Baseline (after 15 minutes of lens dispense) | Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Subjects will be randomized to wear the Phenacite and comfilcon A contact lenses binocularly for two weeks.
Phenacite: contact lenses (Not the final Design - Further clinical studies were conducted to validate the new design)
comfilcon A: contact lenses | 24 |
| Total | 24 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Second Intervention | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Overall Study | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 24 Participants | — |
| Age, Continuous | 27 years STANDARD_DEVIATION 5 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 24 participants | — |
| Sex: Female, Male Female | 22 Participants | — |
| Sex: Female, Male Male | 2 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 |
Outcome results
Primary
Binocular Distance Visual Acuity - High Illumination High Contrast
Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
Time frame: Baseline (after 5 minutes of lens dispense)
Population: One subject was excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite | Binocular Distance Visual Acuity - High Illumination High Contrast | -0.18 logMAR | Standard Deviation 0.06 |
| Comfilcon A | Binocular Distance Visual Acuity - High Illumination High Contrast | -0.21 logMAR | Standard Deviation 0.06 |
Primary
Binocular Distance Visual Acuity - High Illumination High Contrast
Binocular Distance Visual Acuity - High Illumination High Contrast was measured using logMAR
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite | Binocular Distance Visual Acuity - High Illumination High Contrast | -0.19 logMAR | Standard Deviation 0.07 |
| Comfilcon A | Binocular Distance Visual Acuity - High Illumination High Contrast | -0.20 logMAR | Standard Deviation 0.05 |
Primary
Binocular Distance Visual Acuity - Low Illumination High Contrast
Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite | Binocular Distance Visual Acuity - Low Illumination High Contrast | 0.00 logMAR | Standard Deviation 0.09 |
| Comfilcon A | Binocular Distance Visual Acuity - Low Illumination High Contrast | 0.00 logMAR | Standard Deviation 0.06 |
Primary
Binocular Distance Visual Acuity - Low Illumination High Contrast
Binocular Distance Visual Acuity - Low Illumination High Contrast was measured using logMAR
Time frame: Baseline (after 5 minutes of lens dispense)
Population: One subject was excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite | Binocular Distance Visual Acuity - Low Illumination High Contrast | 0.03 logMAR | Standard Deviation 0.08 |
| Comfilcon A | Binocular Distance Visual Acuity - Low Illumination High Contrast | 0.00 logMAR | Standard Deviation 0.07 |
Primary
Binocular Near Visual Acuity - High Illumination High Contrast
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite | Binocular Near Visual Acuity - High Illumination High Contrast | -0.20 logMAR | Standard Deviation 0.06 |
| Comfilcon A | Binocular Near Visual Acuity - High Illumination High Contrast | -0.18 logMAR | Standard Deviation 0.06 |
Primary
Binocular Near Visual Acuity - High Illumination High Contrast
Binocular Near Visual Acuity - High Illumination High Contrast was measured using logMAR
Time frame: Baseline (after 5 minutes of lens dispense)
Population: One subject was excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite | Binocular Near Visual Acuity - High Illumination High Contrast | -0.16 logMAR | Standard Deviation 0.06 |
| Comfilcon A | Binocular Near Visual Acuity - High Illumination High Contrast | -0.19 logMAR | Standard Deviation 0.06 |
Primary
Binocular Near Visual Acuity - Low Illumination High Contrast
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite | Binocular Near Visual Acuity - Low Illumination High Contrast | -0.02 logMAR | Standard Deviation 0.09 |
| Comfilcon A | Binocular Near Visual Acuity - Low Illumination High Contrast | -0.03 logMAR | Standard Deviation 0.08 |
Primary
Binocular Near Visual Acuity - Low Illumination High Contrast
Binocular Near Visual Acuity - Low Illumination High Contrast was measured using logMAR
Time frame: Baseline (after 5 minutes of lens dispense)
Population: One subject was excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite | Binocular Near Visual Acuity - Low Illumination High Contrast | 0.01 logMAR | Standard Deviation 0.07 |
| Comfilcon A | Binocular Near Visual Acuity - Low Illumination High Contrast | -0.01 logMAR | Standard Deviation 0.1 |
Primary
Over Refraction for Optimized Distance Acuity
Over Refraction for optimized distance acuity measured using logMAR
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite | Over Refraction for Optimized Distance Acuity | OD (oculus dexter - right eye) | -0.10 logMAR | Standard Deviation 0.09 |
| Phenacite | Over Refraction for Optimized Distance Acuity | OS (Oculus sinister - left eye) | -0.02 logMAR | Standard Deviation 0.07 |
| Comfilcon A | Over Refraction for Optimized Distance Acuity | OD (oculus dexter - right eye) | 0.00 logMAR | Standard Deviation 0 |
| Comfilcon A | Over Refraction for Optimized Distance Acuity | OS (Oculus sinister - left eye) | 0.00 logMAR | Standard Deviation 0 |
Primary
Subjective Ratings of Lens Comfort
Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
Time frame: Baseline (after 15 minutes of lens dispense)
Population: One subject was excluded from the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite | Subjective Ratings of Lens Comfort | 86.50 units on a scale | Standard Deviation 14.99 |
| Comfilcon A | Subjective Ratings of Lens Comfort | 90.13 units on a scale | Standard Deviation 8.6 |
Primary
Subjective Ratings of Lens Comfort
Subjective ratings of lens comfort. Comfort Scale (0,100; 0=extremely uncomfortable/cannot tolerate; 100 = extremely comfortable/cannot be felt)
Time frame: 2 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite | Subjective Ratings of Lens Comfort | 66.46 units on a scale | Standard Deviation 25.22 |
| Comfilcon A | Subjective Ratings of Lens Comfort | 71.71 units on a scale | Standard Deviation 24.62 |
Secondary
Conjunctival Staining
Conjunctival staining was assessed on a scale of 0-4, 0.50 steps (0-None, 1 - Minimal diffuse punctuate, 2- Coalescent Punctuate, 3- confluent, 4- Deep confluent
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite | Conjunctival Staining | Nasal | 0.48 units on a scale | Standard Deviation 0.46 |
| Phenacite | Conjunctival Staining | Inferior | 0.02 units on a scale | Standard Deviation 0.1 |
| Phenacite | Conjunctival Staining | Temporal | 0.11 units on a scale | Standard Deviation 0.36 |
| Phenacite | Conjunctival Staining | Superior | 0.00 units on a scale | Standard Deviation 0 |
| Comfilcon A | Conjunctival Staining | Superior | 0.05 units on a scale | Standard Deviation 0.26 |
| Comfilcon A | Conjunctival Staining | Temporal | 0.18 units on a scale | Standard Deviation 0.43 |
| Comfilcon A | Conjunctival Staining | Inferior | 0.10 units on a scale | Standard Deviation 0.27 |
| Comfilcon A | Conjunctival Staining | Nasal | 0.38 units on a scale | Standard Deviation 0.57 |
Secondary
Corneal Staining Extent
Corneal staining extent was assessed 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: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite | Corneal Staining Extent | Central | 0.02 units on a scale | Standard Deviation 0.14 |
| Phenacite | Corneal Staining Extent | Temporal | 0.00 units on a scale | Standard Deviation 0 |
| Phenacite | Corneal Staining Extent | Nasal | 0.00 units on a scale | Standard Deviation 0 |
| Phenacite | Corneal Staining Extent | Superior | 0.00 units on a scale | Standard Deviation 0 |
| Phenacite | Corneal Staining Extent | Inferior | 0.21 units on a scale | Standard Deviation 0.5 |
| Comfilcon A | Corneal Staining Extent | Superior | 0.04 units on a scale | Standard Deviation 0.2 |
| Comfilcon A | Corneal Staining Extent | Inferior | 0.42 units on a scale | Standard Deviation 0.58 |
| Comfilcon A | Corneal Staining Extent | Central | 0.00 units on a scale | Standard Deviation 0 |
| Comfilcon A | Corneal Staining Extent | Nasal | 0.00 units on a scale | Standard Deviation 0 |
| Comfilcon A | Corneal Staining Extent | Temporal | 0.00 units on a scale | Standard Deviation 0 |
Secondary
Lens Fit - Post Blink Movement
Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Time frame: Baseline (after 15 minutes of lens dispense)
Population: One Subject was excluded from the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite | Lens Fit - Post Blink Movement | OD (oculus dexter - right eye) | 0.23 mm | Standard Deviation 0.07 |
| Phenacite | Lens Fit - Post Blink Movement | OS(oculus sinister - left eye) | 0.23 mm | Standard Deviation 0.07 |
| Comfilcon A | Lens Fit - Post Blink Movement | OS(oculus sinister - left eye) | 0.22 mm | Standard Deviation 0.07 |
| Comfilcon A | Lens Fit - Post Blink Movement | OD (oculus dexter - right eye) | 0.20 mm | Standard Deviation 0.06 |
Secondary
Lens Fit - Post Blink Movement
Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite | Lens Fit - Post Blink Movement | OD (oculus dexter - right eye) | 0.24 mm | Standard Deviation 0.09 |
| Phenacite | Lens Fit - Post Blink Movement | OS (oculus sinister - left eye) | 0.25 mm | Standard Deviation 0.08 |
| Comfilcon A | Lens Fit - Post Blink Movement | OD (oculus dexter - right eye) | 0.23 mm | Standard Deviation 0.08 |
| Comfilcon A | Lens Fit - Post Blink Movement | OS (oculus sinister - left eye) | 0.24 mm | Standard Deviation 0.07 |
Secondary
Lens Mobility Rating
Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (\>1mm) on versions in all directions in 0.25 steps
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite | Lens Mobility Rating | OD (oculus dexter - right eye) | 2.91 units on a scale | Standard Deviation 0.35 |
| Phenacite | Lens Mobility Rating | OS (oculus sinister - left eye) | 3.00 units on a scale | Standard Deviation 0.33 |
| Comfilcon A | Lens Mobility Rating | OD (oculus dexter - right eye) | 3.08 units on a scale | Standard Deviation 0.31 |
| Comfilcon A | Lens Mobility Rating | OS (oculus sinister - left eye) | 3.10 units on a scale | Standard Deviation 0.28 |
Secondary
Lens Mobility Rating
Investigator assessment using 5 Categories in 0.50 steps: 0=Immobile - no lag in any versions, 1=Restricted - no lag in some directions but slight lag (0-0.25mm) in others, 2=Secure - slight lag (0.25-0.5mm in each version), 3=Unrestricted - freely lags in a controlled manner on all versions, but not excessive (0.5-1.0mm), 4=Very mobile - excessive lag (\>1mm) on versions in all directions in 0.25 steps
Time frame: Baseline (after 15 minutes of lens dispense)
Population: One Subject was excluded from the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite | Lens Mobility Rating | OD (oculus dexter - Right Eye) | 3.07 units on a scale | Standard Deviation 0.34 |
| Phenacite | Lens Mobility Rating | OS (Oculus Sinister - Left eye) | 3.09 units on a scale | Standard Deviation 0.32 |
| Comfilcon A | Lens Mobility Rating | OD (oculus dexter - Right Eye) | 2.99 units on a scale | Standard Deviation 0.36 |
| Comfilcon A | Lens Mobility Rating | OS (Oculus Sinister - Left eye) | 3.01 units on a scale | Standard Deviation 0.35 |
Secondary
Overall Lens Fit Acceptance
Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
Time frame: Baseline (after 15 minutes of lens dispense)
Population: One Subject was excluded from the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite | Overall Lens Fit Acceptance | OD (oculus dexter - right eye) | 3.35 units on a scale | Standard Deviation 0.25 |
| Phenacite | Overall Lens Fit Acceptance | OS ( oculus sinister - Left Eye) | 3.37 units on a scale | Standard Deviation 0.24 |
| Comfilcon A | Overall Lens Fit Acceptance | OD (oculus dexter - right eye) | 3.30 units on a scale | Standard Deviation 0.32 |
| Comfilcon A | Overall Lens Fit Acceptance | OS ( oculus sinister - Left Eye) | 3.30 units on a scale | Standard Deviation 0.28 |
Secondary
Overall Lens Fit Acceptance
Investigator assessment using 5 Categories in 0.25 steps: 0=Can't be worn, 1=Poor - should not be dispensed although no immediate danger, 2=Fair, 3=Good, 4=Optimum in 0.25 steps
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite | Overall Lens Fit Acceptance | OS (oculus sinister - left eye) | 3.32 units on a scale | Standard Deviation 0.32 |
| Phenacite | Overall Lens Fit Acceptance | OD (oculus dexter- right eye) | 3.25 units on a scale | Standard Deviation 0.35 |
| Comfilcon A | Overall Lens Fit Acceptance | OD (oculus dexter- right eye) | 3.34 units on a scale | Standard Deviation 0.34 |
| Comfilcon A | Overall Lens Fit Acceptance | OS (oculus sinister - left eye) | 3.36 units on a scale | Standard Deviation 0.36 |
Secondary
Push - Up Test for Lens Tightness
Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
Time frame: 2 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite | Push - Up Test for Lens Tightness | OD (oculus dexter - right eye) | 52.83 mm | Standard Deviation 7.64 |
| Phenacite | Push - Up Test for Lens Tightness | OS (Oculus Sinister - Left Eye) | 51.30 mm | Standard Deviation 5.94 |
| Comfilcon A | Push - Up Test for Lens Tightness | OD (oculus dexter - right eye) | 49.35 mm | Standard Deviation 4.5 |
| Comfilcon A | Push - Up Test for Lens Tightness | OS (Oculus Sinister - Left Eye) | 48.70 mm | Standard Deviation 4.23 |
Secondary
Push - Up Test for Lens Tightness
Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement
Time frame: Baseline (after 15 minutes of lens dispense)
Population: One Subject was excluded from the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Phenacite | Push - Up Test for Lens Tightness | OD (oculus Dexter - Right eye) | 50.43 mm | Standard Deviation 5.09 |
| Phenacite | Push - Up Test for Lens Tightness | OS (Oculus Sinister - Left eye) | 49.78 mm | Standard Deviation 4.77 |
| Comfilcon A | Push - Up Test for Lens Tightness | OD (oculus Dexter - Right eye) | 51.52 mm | Standard Deviation 5.4 |
| Comfilcon A | Push - Up Test for Lens Tightness | OS (Oculus Sinister - Left eye) | 50.65 mm | Standard Deviation 4.73 |
Secondary
Subjective Ratings for Vision Quality - Computer Vision
Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite | Subjective Ratings for Vision Quality - Computer Vision | 85.04 units on a scale | Standard Deviation 21.27 |
| Comfilcon A | Subjective Ratings for Vision Quality - Computer Vision | 89.08 units on a scale | Standard Deviation 15.06 |
Secondary
Subjective Ratings for Vision Quality - Computer Vision
Patient subjective scoring using 0-100 continuous scale for Computer Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
Time frame: Baseline (after 15 minutes of lens dispense)
Population: One Subject was excluded from the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite | Subjective Ratings for Vision Quality - Computer Vision | 92.79 units on a scale | Standard Deviation 10.75 |
| Comfilcon A | Subjective Ratings for Vision Quality - Computer Vision | 93.17 units on a scale | Standard Deviation 8.91 |
Secondary
Subjective Ratings for Vision Quality - Distance Vision
Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite | Subjective Ratings for Vision Quality - Distance Vision | 85.33 units on a scale | Standard Deviation 20.5 |
| Comfilcon A | Subjective Ratings for Vision Quality - Distance Vision | 88.88 units on a scale | Standard Deviation 15.34 |
Secondary
Subjective Ratings for Vision Quality - Distance Vision
Patient subjective scoring using 0-100 continuous scale for Distance Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
Time frame: Baseline (after 15 minutes of lens dispense)
Population: One Subject was excluded from the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite | Subjective Ratings for Vision Quality - Distance Vision | 86.58 units on a scale | Standard Deviation 17.13 |
| Comfilcon A | Subjective Ratings for Vision Quality - Distance Vision | 91.3 units on a scale | Standard Deviation 10.64 |
Secondary
Subjective Ratings for Vision Quality - Near Vision
Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
Time frame: Baseline (after 15 minutes of lens dispense)
Population: One Subject was excluded from the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite | Subjective Ratings for Vision Quality - Near Vision | 92.00 units on a scale | Standard Deviation 11.16 |
| Comfilcon A | Subjective Ratings for Vision Quality - Near Vision | 92.63 units on a scale | Standard Deviation 7.7 |
Secondary
Subjective Ratings for Vision Quality - Near Vision
Patient subjective scoring using 0-100 continuous scale for Near Quality of Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite | Subjective Ratings for Vision Quality - Near Vision | 84.83 units on a scale | Standard Deviation 23.88 |
| Comfilcon A | Subjective Ratings for Vision Quality - Near Vision | 85.88 units on a scale | Standard Deviation 21.67 |
Secondary
Subjective Ratings for Vision Quality - Overall Vision
Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
Time frame: Baseline (after 15 minutes of lens dispense)
Population: One Subject was excluded from the analysis
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite | Subjective Ratings for Vision Quality - Overall Vision | 91.00 units on a scale | Standard Deviation 10.64 |
| Comfilcon A | Subjective Ratings for Vision Quality - Overall Vision | 92.67 units on a scale | Standard Deviation 7.41 |
Secondary
Subjective Ratings for Vision Quality - Overall Vision
Patient subjective scoring using 0-100 continuous scale for Overall Vision: 0=extremely poor vision all of the time. Cannot function; 20= Frequently annoying vision problems; 40=Occasionally annoying vision problems; 60=occasionally noticeable but not annoying vision problems; 80=rarely noticeable vision problems; 100=excellent vision all of the time
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Phenacite | Subjective Ratings for Vision Quality - Overall Vision | 85.96 units on a scale | Standard Deviation 17.66 |
| Comfilcon A | Subjective Ratings for Vision Quality - Overall Vision | 88.63 units on a scale | Standard Deviation 14.36 |