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One Week Assessment of The Phenacite Lens

One Week Assessment of The Phenacite Lens

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02553395
Enrollment
30
Registered
2015-09-17
Start date
2015-09-30
Completion date
2015-10-31
Last updated
2020-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Brief summary

This study will investigate performance criteria over one week of daily wear to determine if the Study Test contact lens performs equivalently to the comfilcon A contact lenses in terms of subjective ratings and of visual performance. The study test lens was not the final optical design and the study results were not used for the design validation.

Detailed description

This will be double-masked, randomized, bilateral crossover study comparing the Study Test lens against the comfilcon A control lens, each worn over one week of daily wear. The study test lens was not the final optical design and the study results were not used for the design validation.

Interventions

DEVICEPhenacite (Test) contact lens

Sponsors

CooperVision, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
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 (Diopter) and -4.50D * Spherical Contact Lens Rx between -1.00 and -4.00 and spectacle cylinder \<-0.75 * 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. * Has any systemic disease affecting ocular health. * Is using any systemic or topical medications that will affect ocular health. * Has any ocular pathology or severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses. * Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye. * Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars. * Is aphakic. * Has undergone corneal refractive surgery. * Is participating in any other type of eye related clinical or research study.

Design outcomes

Primary

MeasureTime frameDescription
Binocular Distance Visual Acuity (VA) - High Illumination High ContrastBaseline - After 5 minutes of lens settlingBinocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)
Binocular Distance Visual Acuity (VA) -High Illumination High Contrast1 weekBinocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)
Binocular Near Visual Acuity (VA) - High Illumination High ContrastBaseline - after 5 minutes of lens dispenseBinocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)
Binocular Distance Visual Acuity (VA) - Low Illumination High ContrastBaseline (After 5 minutes of lens settling)Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Binocular Near Visual Acuity (VA) - Low Illumination High ContrastBaseline (after 5 minutes of lens settling)Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)
Subjective Ratings for Distance Quality of Vision1 weekPatient subjective scoring using anchors on the scale to provide a score between 0-100 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 Intermediate Quality of Vision1 weekPatient subjective scoring using anchors on the scale to provide a score between 0-100 for Intermediate 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 Near Quality of Vision1 weekPatient subjective scoring using anchors on the scale to provide a score between 0-100 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)

Secondary

MeasureTime frameDescription
Post Blink Movement -Baseline (After 5 minutes of lens dispense)Post blink movement was assessed by the investigator by the amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Subjective Overall Lens Preference1 weekPatient subjective overall preference: Phenacite test lens, comfilcon A or No Preference
Post Blink Movement1 weekInvestigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)
Push - Up Test for Lens TightnessBaseline (After 5 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 RatingBaseline (after 5 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 AcceptanceBaseline (After 5 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 Lens Preference - Distance Vision1 weekPatient subjective preference: Phenacite lens, comfilcon A or No Preference
Subjective Lens Preference -Overall Vision Preference1 weekPatient subjective preference: Phenacite test lens, comfilcon A or No Preference
Subjective Lens Preference - Comfort1 weekPatient subjective preference: Phenacite test lens, comfilcon A or No Preference

Countries

United States

Participant flow

Participants by arm

ArmCount
Overall Study
Subjects were randomized to wear test lens for one week and then cross-over to control lens for one week.
30
Total30

Baseline characteristics

CharacteristicOverall Study
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
30 Participants
Age, Continuous25 years
STANDARD_DEVIATION 3
Race and Ethnicity Not Collected— Participants
Region of Enrollment
United States
30 participants
Sex: Female, Male
Female
24 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 300 / 30
other
Total, other adverse events
0 / 300 / 30
serious
Total, serious adverse events
0 / 300 / 30

Outcome results

Primary

Binocular Distance Visual Acuity (VA) - High Illumination High Contrast

Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)

Time frame: Baseline - After 5 minutes of lens settling

ArmMeasureValue (MEAN)Dispersion
Phenacite Contact LensBinocular Distance Visual Acuity (VA) - High Illumination High Contrast-0.22 logMARStandard Deviation 0.05
Comfilcon A Contact LensBinocular Distance Visual Acuity (VA) - High Illumination High Contrast-0.24 logMARStandard Deviation 0.05
Primary

Binocular Distance Visual Acuity (VA) -High Illumination High Contrast

Binocular Distance visual acuity High Illumination High Contrast was assessed using logMAR (0.02 logMAR= 1 letter)

Time frame: 1 week

ArmMeasureValue (MEAN)Dispersion
Phenacite Contact LensBinocular Distance Visual Acuity (VA) -High Illumination High Contrast-0.20 logMARStandard Deviation 0.05
Comfilcon A Contact LensBinocular Distance Visual Acuity (VA) -High Illumination High Contrast-0.22 logMARStandard Deviation 0.06
Primary

Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast

Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)

Time frame: 1 week

ArmMeasureValue (MEAN)Dispersion
Phenacite Contact LensBinocular Distance Visual Acuity (VA) - Low Illumination High Contrast0.00 LogMARStandard Deviation 0.08
Comfilcon A Contact LensBinocular Distance Visual Acuity (VA) - Low Illumination High Contrast-0.04 LogMARStandard Deviation 0.06
Primary

Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast

Binocular Distance Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)

Time frame: Baseline (After 5 minutes of lens settling)

ArmMeasureValue (MEAN)Dispersion
Phenacite Contact LensBinocular Distance Visual Acuity (VA) - Low Illumination High Contrast-0.02 LogMARStandard Deviation 0.05
Comfilcon A Contact LensBinocular Distance Visual Acuity (VA) - Low Illumination High Contrast-0.04 LogMARStandard Deviation 0.07
Primary

Binocular Near Visual Acuity (VA) - High Illumination High Contrast

Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)

Time frame: Baseline - after 5 minutes of lens dispense

ArmMeasureValue (MEAN)Dispersion
Phenacite Contact LensBinocular Near Visual Acuity (VA) - High Illumination High Contrast-0.18 logMARStandard Deviation 0.06
Comfilcon A Contact LensBinocular Near Visual Acuity (VA) - High Illumination High Contrast-0.19 logMARStandard Deviation 0.07
Primary

Binocular Near Visual Acuity (VA) - High Illumination High Contrast

Binocular Near Visual Acuity High Illumination High Contrast was assessed on logMAR VA (0.02 logMAR= 1 letter)

Time frame: 1-week

ArmMeasureValue (MEAN)Dispersion
Phenacite Contact LensBinocular Near Visual Acuity (VA) - High Illumination High Contrast-0.19 logMARStandard Deviation 0.06
Comfilcon A Contact LensBinocular Near Visual Acuity (VA) - High Illumination High Contrast-0.19 logMARStandard Deviation 0.06
Primary

Binocular Near Visual Acuity (VA) - Low Illumination High Contrast

Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)

Time frame: 1week

ArmMeasureValue (MEAN)Dispersion
Phenacite Contact LensBinocular Near Visual Acuity (VA) - Low Illumination High Contrast-0.01 LogMARStandard Deviation 0.08
Comfilcon A Contact LensBinocular Near Visual Acuity (VA) - Low Illumination High Contrast-0.00 LogMARStandard Deviation 0.06
Primary

Binocular Near Visual Acuity (VA) - Low Illumination High Contrast

Binocular Near Visual Acuity (VA) - Low Illumination High Contrast was assessed using logMAR VA (0.02 logMAR= 1 letter)

Time frame: Baseline (after 5 minutes of lens settling)

ArmMeasureValue (MEAN)Dispersion
Phenacite Contact LensBinocular Near Visual Acuity (VA) - Low Illumination High Contrast-0.00 LogMARStandard Deviation 0.07
Comfilcon A Contact LensBinocular Near Visual Acuity (VA) - Low Illumination High Contrast0.00 LogMARStandard Deviation 0.07
Primary

Subjective Ratings for Distance Quality of Vision

Patient subjective scoring using anchors on the scale to provide a score between 0-100 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: 1 week

ArmMeasureGroupValue (MEAN)Dispersion
Phenacite Contact LensSubjective Ratings for Distance Quality of Visioncomfilcon A control lens91 score on a scaleStandard Deviation 9
Phenacite Contact LensSubjective Ratings for Distance Quality of VisionPhenacite Test Contact Lens85 score on a scaleStandard Deviation 15
Primary

Subjective Ratings for Intermediate Quality of Vision

Patient subjective scoring using anchors on the scale to provide a score between 0-100 for Intermediate 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: 1 week

ArmMeasureGroupValue (MEAN)Dispersion
Phenacite Contact LensSubjective Ratings for Intermediate Quality of VisionPhenacite Test Lens91 score on a scaleStandard Deviation 10
Phenacite Contact LensSubjective Ratings for Intermediate Quality of Visioncomfilcon A control lens95 score on a scaleStandard Deviation 7
Primary

Subjective Ratings for Near Quality of Vision

Patient subjective scoring using anchors on the scale to provide a score between 0-100 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: 1 week

ArmMeasureGroupValue (MEAN)Dispersion
Phenacite Contact LensSubjective Ratings for Near Quality of VisionPhenacite Test Lens92 score on a scaleStandard Deviation 11
Phenacite Contact LensSubjective Ratings for Near Quality of Visioncomfilcon A control lens95 score on a scaleStandard Deviation 6
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 5 minutes of lens dispense)

ArmMeasureGroupValue (MEAN)Dispersion
Phenacite Contact LensLens Mobility RatingRight eye2.97 units on a scaleStandard Deviation 0.2
Phenacite Contact LensLens Mobility RatingLeft eye2.97 units on a scaleStandard Deviation 0.22
Comfilcon A Contact LensLens Mobility RatingRight eye3.00 units on a scaleStandard Deviation 0.26
Comfilcon A Contact LensLens Mobility RatingLeft eye3.02 units on a scaleStandard Deviation 0.25
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: 1 week

ArmMeasureGroupValue (MEAN)Dispersion
Phenacite Contact LensLens Mobility RatingRight Eye2.98 units on a scaleStandard Deviation 0.25
Phenacite Contact LensLens Mobility RatingLeft eye3.02 units on a scaleStandard Deviation 0.31
Comfilcon A Contact LensLens Mobility RatingRight Eye3.04 units on a scaleStandard Deviation 0.16
Comfilcon A Contact LensLens Mobility RatingLeft eye3.04 units on a scaleStandard Deviation 0.16
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: 1 week

ArmMeasureGroupValue (MEAN)Dispersion
Phenacite Contact LensOverall Lens Fit AcceptanceRight eye3.42 units on a scaleStandard Deviation 0.28
Phenacite Contact LensOverall Lens Fit AcceptanceLeft Eye3.35 units on a scaleStandard Deviation 0.52
Comfilcon A Contact LensOverall Lens Fit AcceptanceRight eye3.48 units on a scaleStandard Deviation 0.28
Comfilcon A Contact LensOverall Lens Fit AcceptanceLeft Eye3.49 units on a scaleStandard 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: Baseline (After 5 minutes of lens dispense)

ArmMeasureGroupValue (MEAN)Dispersion
Phenacite Contact LensOverall Lens Fit AcceptanceRight Eye3.48 units on a scaleStandard Deviation 0.22
Phenacite Contact LensOverall Lens Fit AcceptanceLeft Eye3.46 units on a scaleStandard Deviation 0.22
Comfilcon A Contact LensOverall Lens Fit AcceptanceRight Eye3.42 units on a scaleStandard Deviation 0.36
Comfilcon A Contact LensOverall Lens Fit AcceptanceLeft Eye3.44 units on a scaleStandard Deviation 0.33
Secondary

Post Blink Movement

Investigator assessment of Amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)

Time frame: 1 week

ArmMeasureGroupValue (MEAN)Dispersion
Phenacite Contact LensPost Blink MovementRight eye0.24 mmStandard Deviation 0.06
Phenacite Contact LensPost Blink MovementLeft Eye0.25 mmStandard Deviation 0.08
Comfilcon A Contact LensPost Blink MovementRight eye0.24 mmStandard Deviation 0.07
Comfilcon A Contact LensPost Blink MovementLeft Eye0.25 mmStandard Deviation 0.06
Secondary

Post Blink Movement -

Post blink movement was assessed by the investigator by the amount of movement (to the nearest 0.1mm) immediately after the blink (0.1mm steps)

Time frame: Baseline (After 5 minutes of lens dispense)

ArmMeasureGroupValue (MEAN)Dispersion
Phenacite Contact LensPost Blink Movement -Right eye0.23 mmStandard Deviation 0.06
Phenacite Contact LensPost Blink Movement -Left eye0.23 mmStandard Deviation 0.06
Comfilcon A Contact LensPost Blink Movement -Right eye0.24 mmStandard Deviation 0.08
Comfilcon A Contact LensPost Blink Movement -Left eye0.25 mmStandard Deviation 0.08
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: 1 week

ArmMeasureGroupValue (MEAN)Dispersion
Phenacite Contact LensPush - Up Test for Lens TightnessLeft eye49.33 units on a scaleStandard Deviation 6.53
Phenacite Contact LensPush - Up Test for Lens TightnessRight Eye50.33 units on a scaleStandard Deviation 4.14
Comfilcon A Contact LensPush - Up Test for Lens TightnessRight Eye49.17 units on a scaleStandard Deviation 3.73
Comfilcon A Contact LensPush - Up Test for Lens TightnessLeft eye49.17 units on a scaleStandard Deviation 2.65
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 5 minutes of lens dispense)

ArmMeasureGroupValue (MEAN)Dispersion
Phenacite Contact LensPush - Up Test for Lens TightnessRight eye50.83 units on a scaleStandard Deviation 4.17
Phenacite Contact LensPush - Up Test for Lens TightnessLeft Eye50.33 units on a scaleStandard Deviation 4.14
Comfilcon A Contact LensPush - Up Test for Lens TightnessRight eye49.67 units on a scaleStandard Deviation 2.92
Comfilcon A Contact LensPush - Up Test for Lens TightnessLeft Eye49.17 units on a scaleStandard Deviation 3.49
Secondary

Subjective Lens Preference - Comfort

Patient subjective preference: Phenacite test lens, comfilcon A or No Preference

Time frame: 1 week

ArmMeasureGroupValue (NUMBER)
Phenacite Contact LensSubjective Lens Preference - ComfortPhenacite43 percentage of participants
Phenacite Contact LensSubjective Lens Preference - Comfortcomfilcon A40 percentage of participants
Phenacite Contact LensSubjective Lens Preference - ComfortNo preference17 percentage of participants
Secondary

Subjective Lens Preference - Distance Vision

Patient subjective preference: Phenacite lens, comfilcon A or No Preference

Time frame: 1 week

ArmMeasureGroupValue (NUMBER)
Phenacite Contact LensSubjective Lens Preference - Distance VisionPhenacite Lens17 percentage of participants
Phenacite Contact LensSubjective Lens Preference - Distance Visioncomfilcon A50 percentage of participants
Phenacite Contact LensSubjective Lens Preference - Distance VisionNo preference33 percentage of participants
Secondary

Subjective Lens Preference -Overall Vision Preference

Patient subjective preference: Phenacite test lens, comfilcon A or No Preference

Time frame: 1 week

ArmMeasureGroupValue (NUMBER)
Phenacite Contact LensSubjective Lens Preference -Overall Vision PreferencePhenacite27 percentage of participants
Phenacite Contact LensSubjective Lens Preference -Overall Vision Preferencecomfilcon A56 percentage of participants
Phenacite Contact LensSubjective Lens Preference -Overall Vision PreferenceNo Preference17 percentage of participants
Secondary

Subjective Overall Lens Preference

Patient subjective overall preference: Phenacite test lens, comfilcon A or No Preference

Time frame: 1 week

ArmMeasureGroupValue (NUMBER)
Phenacite Contact LensSubjective Overall Lens PreferencePhenacite33 percentage of participants
Phenacite Contact LensSubjective Overall Lens Preferencecomfilcon A57 percentage of participants
Phenacite Contact LensSubjective Overall Lens PreferenceNo preference10 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026