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CompletedNCT02642991Updated Dec 1, 2020Results posted

Dispensing Study for a New Study Lens

An interventional study of Phenacite and comfilcon A in Myopia, sponsored by CooperVision International Limited (CVIL). Completed at 3 sites in 2 countries. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2020-12-01.

Sponsored by CooperVision International Limited (CVIL) · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Myopia

Browse trials for

03

In context

Myopia

984 studies on the registry are indexed under Myopia; 210 are open to participants now.

This study's enrollment of 44 is below the median of 80 across 783 interventional studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

CooperVision International Limited (CVIL) is the lead sponsor of 138 studies on the registry; 9 are open to participants now.

Of its 72 completed or terminated interventional studies of FDA-regulated products, 67 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts 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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    Phenacite Test lens then comfilcon A control lens

    Participants were randomized to wear Phenacite test lens for one week then cross-over to wear comfilcon A control lens for one week.

    Device: Phenacite · Device: comfilcon A

  • Active comparator
    Comfilcon A control lens then Phenacite test Lens

    Participants were randomized to wear comfilcon A control lens for one week then cross over to Phenacite test lens for one week.

    Device: Phenacite · Device: comfilcon A

Interventions

  • DevicePhenacite

    contact lens

  • Devicecomfilcon A

    contact lens

06

What researchers measure

Primary outcomes

  1. Distance Visual Acuity (VA) - High Illumination

    Distance visual acuity High Illumination was assessed using logMAR

    Time frame: Baseline (after 10 minutes of lens dispense)

  2. Distance Visual Acuity (VA) - High Illumination

    Distance visual acuity High Illumination was assessed using logMAR

    Time frame: 1 week

  3. Near Visual Acuity (VA) - High Illumination

    Near Visual Acuity (VA) - High Illumination assessed using logMAR

    Time frame: Baseline (after 10 minutes of lens dispense)

  4. Near Visual Acuity (VA) - High Illumination

    Near Visual Acuity (VA) - High Illumination assessed using logMAR

    Time frame: 1 week

  5. Distance Visual Acuity (VA) - Low Illumination

    Distance Visual Acuity (VA) - Low Illumination assessed using logMAR

    Time frame: Baseline (after 10 minutes of lens dispense)

  6. Distance Visual Acuity (VA) - Low Illumination

    Distance Visual Acuity (VA) - Low Illumination assessed using logMAR

    Time frame: 1 week

  7. Near Visual Acuity (VA) - Low Illumination

    Near Visual Acuity (VA) - Low illumination assessed using logMAR

    Time frame: Baseline (after 10 minutes of lens dispense)

  8. Near Visual Acuity (VA) - Low Illumination

    Near Visual Acuity (VA) - Low illumination assessed using logMAR

    Time frame: 1 week

  9. 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)

  10. 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

  11. 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)

  12. 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

  13. 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)

  14. 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

  15. 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)

  16. 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

  17. 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)

  18. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. Ghosting - Distance Vision

    Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable

    Time frame: 1 week

  5. Ghosting - Near Vision

    Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable

    Time frame: 1 week

  6. 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)

  7. 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

  8. 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)

  9. 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

  10. Lens Preference - Overall Vision Preference

    Subjective rating of lens preference for overall vision preference (Phenacite, comfilcon A, No preference)

    Time frame: 1 week

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. Subjective Questionnaire Response - Eye Feel Good

    Subjective questionnaire response for " These lenses make my eyes feel good" - Agree, Disagree

    Time frame: 1 week

  19. Subjective Questionnaire Response - Eye Feel Relaxed

    Subjective questionnaire response for " These lenses make my eyes feel relaxed" - Agree, Disagree

    Time frame: 1 week

  20. Subjective Questionnaire Response - Vision

    Subjective questionnaire response for " These lenses help my vision" - Agree, Disagree

    Time frame: 1 week

  21. Subjective Questionnaire Response - Eye Tired

    Subjective questionnaire response for " These lenses make my eyes feel less tired" - Agree, Disagree

    Time frame: 1 week

07

Results

Posted Dec 1, 2020

Participant flow

First Intervention
Participant flow — First Intervention
MilestonePhenacite Test Lens Then Comfilcon A Control LensComfilcon A Control Lens Then Phenacite Test Lens
Started2222
Completed2222
Not completed00
Second Intervention
Participant flow — Second Intervention
MilestonePhenacite Test Lens Then Comfilcon A Control LensComfilcon A Control Lens Then Phenacite Test Lens
Started2222
Completed2222
Not completed00

Outcome measures

PrimaryDistance Visual Acuity (VA) - High Illumination

Distance visual acuity High Illumination was assessed using logMAR

Time frame:
Baseline (after 10 minutes of lens dispense)
Reported as:
Mean · logMAR
Distance Visual Acuity (VA) - High Illumination
logMARPhenacite Test LensComfilcon A Control Lens
Monocular-0.10 ± 0.07-0.11 ± 0.08
Binocular-0.15 ± 0.06-0.17 ± 0.07
PrimaryDistance Visual Acuity (VA) - High Illumination

Distance visual acuity High Illumination was assessed using logMAR

Time frame:
1 week
Reported as:
Mean · logMAR
Distance Visual Acuity (VA) - High Illumination
logMARPhenacite Test LensComfilcon A Control Lens
Monocular-0.10 ± 0.08-0.11 ± 0.08
Binocular-0.15 ± 0.07-0.16 ± 0.06
PrimaryNear Visual Acuity (VA) - High Illumination

Near Visual Acuity (VA) - High Illumination assessed using logMAR

Time frame:
Baseline (after 10 minutes of lens dispense)
Reported as:
Mean · logMAR
Near Visual Acuity (VA) - High Illumination
logMARPhenacite Test LensComfilcon A Control Lens
Monocular-0.07 ± 0.09-0.08 ± 0.08
Binocular-0.13 ± 0.09-0.14 ± 0.08
PrimaryNear Visual Acuity (VA) - High Illumination

Near Visual Acuity (VA) - High Illumination assessed using logMAR

Time frame:
1 week
Reported as:
Mean · logMAR
Near Visual Acuity (VA) - High Illumination
logMARPhenacite Test LensComfilcon A Control Lens
Monocular-0.06 ± 0.10-0.07 ± 0.09
Binocular-0.11 ± 0.09-0.13 ± 0.10
PrimaryDistance Visual Acuity (VA) - Low Illumination

Distance Visual Acuity (VA) - Low Illumination assessed using logMAR

Time frame:
Baseline (after 10 minutes of lens dispense)
Reported as:
Mean · logMAR
Distance Visual Acuity (VA) - Low Illumination
logMARPhenacite Test LensComfilcon A Control Lens
Monocular0.07 ± 0.080.05 ± 0.08
Binocular0.02 ± 0.060.00 ± 0.06
PrimaryDistance Visual Acuity (VA) - Low Illumination

Distance Visual Acuity (VA) - Low Illumination assessed using logMAR

Time frame:
1 week
Reported as:
Mean · logMAR
Distance Visual Acuity (VA) - Low Illumination
logMARPhenacite Test LensComfilcon A Control Lens
Monocular0.06 ± 0.080.05 ± 0.10
Binocular-0.01 ± 0.060.01 ± 0.07
PrimaryNear Visual Acuity (VA) - Low Illumination

Near Visual Acuity (VA) - Low illumination assessed using logMAR

Time frame:
Baseline (after 10 minutes of lens dispense)
Reported as:
Mean · logMAR
Near Visual Acuity (VA) - Low Illumination
logMARPhenacite Test LensComfilcon A Control Lens
Monocular0.15 ± 0.160.14 ± 0.15
Binocular0.10 ± 0.160.08 ± 0.15
PrimaryNear Visual Acuity (VA) - Low Illumination

Near Visual Acuity (VA) - Low illumination assessed using logMAR

Time frame:
1 week
Reported as:
Mean · logMAR
Near Visual Acuity (VA) - Low Illumination
logMARPhenacite Test LensComfilcon A Control Lens
Monocular0.16 ± 0.170.18 ± 0.17
Binocular0.09 ± 0.160.11 ± 0.17
PrimaryQuality 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)
Reported as:
Mean · units on a scale
Quality of Distance Vision
units on a scalePhenacite Test LensComfilcon A Control Lens
Quality of Distance Vision91 ± 988 ± 15
PrimaryQuality 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
Reported as:
Mean · units on a scale
Quality of Distance Vision
units on a scalePhenacite Test LensComfilcon A Control Lens
Quality of Distance Vision87 ± 1690 ± 12
PrimaryQuality 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)
Reported as:
Mean · units on a scale
Quality of Near Vision
units on a scalePhenacite Test LensComfilcon A Control Lens
Quality of Near Vision94 ± 891 ± 11
PrimaryQuality 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
Reported as:
Mean · units on a scale
Quality of Near Vision
units on a scalePhenacite Test LensComfilcon A Control Lens
Quality of Near Vision90 ± 1290 ± 12
PrimaryQuality 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)
Reported as:
Mean · units on a scale
Quality of Vision With Digital Device Use
units on a scalePhenacite Test LensComfilcon A Control Lens
Quality of Vision With Digital Device Use96 ± 894 ± 7
PrimaryQuality 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
Reported as:
Mean · units on a scale
Quality of Vision With Digital Device Use
units on a scalePhenacite Test LensComfilcon A Control Lens
Quality of Vision With Digital Device Use91 ± 1390 ± 12
PrimaryQuality 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)
Reported as:
Mean · units on a scale
Quality of Intermediate Vision
units on a scalePhenacite Test LensComfilcon A Control Lens
Quality of Intermediate Vision97 ± 693 ± 9
PrimaryQuality 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
Reported as:
Mean · units on a scale
Quality of Intermediate Vision
units on a scalePhenacite Test LensComfilcon A Control Lens
Quality of Intermediate Vision92 ± 1192 ± 10
PrimaryOverall 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)
Reported as:
Mean · units on a scale
Overall Vision Quality
units on a scalePhenacite Test LensComfilcon A Control Lens
Overall Vision Quality95 ± 689 ± 13
PrimaryOverall 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
Reported as:
Mean · units on a scale
Overall Vision Quality
units on a scalePhenacite Test LensComfilcon A Control Lens
Overall Vision Quality88 ± 1589 ± 12
SecondaryBiomicroscopy 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
Reported as:
Mean · units on a scale
Biomicroscopy Findings - Bulbar Hyperemia
units on a scalePhenacite Test LensComfilcon A Control Lens
Biomicroscopy Findings - Bulbar Hyperemia1.24 ± 0.671.37 ± 0.82
SecondaryBiomicroscopy 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
Reported as:
Mean · units on a scale
Biomicroscopy Findings- Limbal Hyperemia
units on a scalePhenacite Test LensComfilcon A Control Lens
Biomicroscopy Findings- Limbal Hyperemia0.98 ± 0.691.21 ± 0.89
SecondaryBiomicroscopy 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
Reported as:
Mean · units on a scale
Biomicroscopy Findings - Corneal Staining Extent
units on a scalePhenacite Test LensComfilcon A Control Lens
Central0.05 ± 0.210.10 ± 0.34
Nasal0.14 ± 0.340.16 ± 0.39
Temporal0.07 ± 0.260.03 ± 0.20
Superior0.13 ± 0.370.19 ± 0.40
Inferior0.34 ± 0.580.51 ± 0.74
SecondaryGhosting - Distance Vision

Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable

Time frame:
1 week
Reported as:
Mean · units on a scale
Ghosting - Distance Vision
units on a scalePhenacite Test LensComfilcon A Control Lens
Ghosting - Distance Vision93 ± 1293 ± 12
SecondaryGhosting - Near Vision

Patient subjective scoring using 0-100 continuous scale:0=Intolerable;100=Not noticable

Time frame:
1 week
Reported as:
Mean · units on a scale
Ghosting - Near Vision
units on a scalePhenacite Test LensComfilcon A Control Lens
Ghosting - Near Vision93 ± 1093 ± 10
SecondaryOverall 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)
Reported as:
Mean · units on a scale
Overall Comfort
units on a scalePhenacite Test LensComfilcon A Control Lens
Overall Comfort91 ± 889 ± 12
SecondaryOverall 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
Reported as:
Mean · units on a scale
Overall Comfort
units on a scalePhenacite Test LensComfilcon A Control Lens
Overall Comfort78 ± 2379 ± 19
SecondaryOverall 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)
Reported as:
Mean · units on a scale
Overall Dryness
units on a scalePhenacite Test LensComfilcon A Control Lens
Overall Dryness92 ± 1292 ± 12
SecondaryOverall 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
Reported as:
Mean · units on a scale
Overall Dryness
units on a scalePhenacite Test LensComfilcon A Control Lens
Overall Dryness76 ± 2377 ± 21
SecondaryLens Preference - Overall Vision Preference

Subjective rating of lens preference for overall vision preference (Phenacite, comfilcon A, No preference)

Time frame:
1 week
Reported as:
Count of participants · Participants
Lens Preference - Overall Vision Preference
ParticipantsOverall Study
Phenacite14
comfilcon A25
No Preference5
SecondarySubjective 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
Reported as:
Number · percentage of participants
Subjective Ratings of Change in Frequency of Tiredness
percentage of participantsPhenaciteComfilcon A
Much Better1118
Better5039
No Difference3639
Worse04
Much Worse40
SecondarySubjective 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
Reported as:
Number · percentage of participants
Subjective Ratings of Change in Severity of Tiredness
percentage of participantsPhenaciteComfilcon A
Much Better1717
Better4839
No Difference2635
Worse49
Much Worse40
SecondarySubjective 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
Reported as:
Number · percentage of participants
Subjective Ratings of Change in Bothersome Rating for Tiredness
percentage of participantsPhenaciteComfilcon A
Much Better2010
Better4545
No Difference3540
Worse05
Much Worse00
SecondarySubjective 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
Reported as:
Number · percentage of participants
Subjective Ratings of Change in Frequency of Dryness
percentage of participantsPhenaciteComfilcon A
Much Better1520
Better3515
No Difference2535
Worse1525
Much Worse105
SecondarySubjective 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
Reported as:
Number · percentage of participants
Subjective Ratings of Change in Severity of Dryness
percentage of participantsPhenaciteComfilcon A
Much Better95
Better4141
No Difference3227
Worse923
Much Worse95
SecondarySubjective 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
Reported as:
Number · percentage of participants
Subjective Ratings of Change in Bothersome Rating of Dryness
percentage of participantsPhenaciteComfilcon A
Much Better1510
Better4040
No Difference2525
Worse1520
Much Worse55
SecondarySubjective Questionnaire Response - Eye Strain

Subjective questionnaire response for " My eyes don't feel strained while wearing these lenses" - Agree, Disagree

Time frame:
1 week
Reported as:
Number · percentage of participants
Subjective Questionnaire Response - Eye Strain
percentage of participantsPhenaciteComfilcon A
Agree7575
Disagree2525
SecondarySubjective Questionnaire Response - Eye Feel Good

Subjective questionnaire response for " These lenses make my eyes feel good" - Agree, Disagree

Time frame:
1 week
Reported as:
Number · percentage of participants
Subjective Questionnaire Response - Eye Feel Good
percentage of participantsPhenaciteComfilcon A
Agree8671
Disagree1429
SecondarySubjective Questionnaire Response - Eye Feel Relaxed

Subjective questionnaire response for " These lenses make my eyes feel relaxed" - Agree, Disagree

Time frame:
1 week
Reported as:
Number · percentage of participants
Subjective Questionnaire Response - Eye Feel Relaxed
percentage of participantsPhenaciteComfilcon A
Agree7979
Disagree2121
SecondarySubjective Questionnaire Response - Vision

Subjective questionnaire response for " These lenses help my vision" - Agree, Disagree

Time frame:
1 week
Reported as:
Number · percentage of participants
Subjective Questionnaire Response - Vision
percentage of participantsPhenaciteComfilcon A
Agree9696
Disagree44
SecondarySubjective Questionnaire Response - Eye Tired

Subjective questionnaire response for " These lenses make my eyes feel less tired" - Agree, Disagree

Time frame:
1 week
Reported as:
Number · percentage of participants
Subjective Questionnaire Response - Eye Tired
percentage of participantsPhenaciteComfilcon A
Agree8275
Disagree1825

Adverse events

Collected over From dispense up to one week on each study lenses, a total of two weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Phenacite Test Lens0/44 (0%)0/44 (0%)0/44 (0%)
Comfilcon A Control Lens0/44 (0%)0/44 (0%)0/44 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Overall Study
<=18 years0
Between 18 and 65 years44
>=65 years0
Age, Continuous
Age, Continuous(years)Overall Study
Mean23.1 ± 3.5
Sex: Female, Male
Sex: Female, Male(Participants)Overall Study
Female34
Male10
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Overall Study
Region of Enrollment
Region of Enrollment(participants)Overall Study
Canada16
United States28
08

Study locations

3 sites
  • University of California
    Berkeley, California 94720, United States
  • CORL, Indiana University
    Bloomington, Indiana 47405, United States
  • Center for Contact Lens Research, University of Waterloo
    Waterloo, Ontario N2L 3G1, Canada
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02642991
Lead sponsor
CooperVision International Limited (CVIL)
Responsible party
Sponsor
First posted
Dec 30, 2015
Start date
Nov 2015
Primary completion
Jan 2016
Completion
Mar 2016
Results posted
Dec 1, 2020
Last update
Dec 1, 2020

Study contacts

Lyndon Jones
principal investigator · CCLR, University of Waterloo
Pete Kollbaum, OD, PhD
principal investigator · CORL, Indiana University
Meng Lin, OD, PhD
principal investigator · CRC, University of California, Berkeley

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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