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Completed

NCT Number: NCT02642991

Dispensing Study for a New Study Lens

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.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Center for Contact Lens Research, University of Waterloo, Waterloo, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phenacite

Device

contact lens

comfilcon A

Device

contact lens

Primary outcomes

  1. Distance Visual Acuity (VA) - High Illumination

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

    Distance visual acuity High Illumination was assessed using logMAR

  2. Distance Visual Acuity (VA) - High Illumination

    Time frame: 1 week

    Distance visual acuity High Illumination was assessed using logMAR

  3. Near Visual Acuity (VA) - High Illumination

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

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

  4. Near Visual Acuity (VA) - High Illumination

    Time frame: 1 week

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

  5. Distance Visual Acuity (VA) - Low Illumination

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

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

  6. Distance Visual Acuity (VA) - Low Illumination

    Time frame: 1 week

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

  7. Near Visual Acuity (VA) - Low Illumination

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

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

  8. Near Visual Acuity (VA) - Low Illumination

    Time frame: 1 week

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

  9. Quality of Distance Vision

    Time frame: 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)

  10. Quality of Distance Vision

    Time frame: 1 week

    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)

  11. Quality of Near Vision

    Time frame: 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

  12. Quality of Near Vision

    Time frame: 1 week

    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

  13. Quality of Vision With Digital Device Use

    Time frame: 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)

  14. Quality of Vision With Digital Device Use

    Time frame: 1 week

    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)

  15. Quality of Intermediate Vision

    Time frame: 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)

  16. Quality of Intermediate Vision

    Time frame: 1 week

    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)

  17. Overall Vision Quality

    Time frame: 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)

  18. Overall Vision Quality

    Time frame: 1 week

    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 outcomes

  1. Biomicroscopy Findings - Bulbar Hyperemia

    Time frame: 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)

  2. Biomicroscopy Findings- Limbal Hyperemia

    Time frame: 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)

  3. Biomicroscopy Findings - Corneal Staining Extent

    Time frame: 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

  4. Ghosting - Distance Vision

    Time frame: 1 week

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

  5. Ghosting - Near Vision

    Time frame: 1 week

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

  6. Overall Comfort

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

    Patient subjective scoring using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.

  7. Overall Comfort

    Time frame: 1 week

    Patient subjective scoring for overall comfort using 0-100 continuous scale, 0= cannot be worn, 100= cannot be felt ever.

  8. Overall Dryness

    Time frame: 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.

  9. Overall Dryness

    Time frame: 1 week

    Patient subjective scoring for overall dryness using 0-100 continuous scale, 0=cannot be worn, 100=no dryness experienced at any time.

  10. Lens Preference - Overall Vision Preference

    Time frame: 1 week

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

  11. Subjective Ratings of Change in Frequency of Tiredness

    Time frame: 1 week

    Subjective rating of change in eye fatigue frequency of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)

  12. Subjective Ratings of Change in Severity of Tiredness

    Time frame: 1 week

    Subjective rating of change in eye fatigue severity of tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)

  13. Subjective Ratings of Change in Bothersome Rating for Tiredness

    Time frame: 1 week

    Subjective rating of change in eye fatigue bothersome rating for tiredness assessed using Eye fatigue Experience Questionnaire (EFEG)

  14. Subjective Ratings of Change in Frequency of Dryness

    Time frame: 1 week

    Subjective rating of change in eye fatigue frequency of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)

  15. Subjective Ratings of Change in Severity of Dryness

    Time frame: 1 week

    Subjective rating of change in eye fatigue severity of dryness assessed using Eye fatigue Experience Questionnaire (EFEG)

  16. Subjective Ratings of Change in Bothersome Rating of Dryness

    Time frame: 1 week

    Subjective rating of change in eye fatigue bothersome rating for dryness assessed using Eye fatigue Experience Questionnaire (EFEG)

  17. Subjective Questionnaire Response - Eye Strain

    Time frame: 1 week

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

  18. Subjective Questionnaire Response - Eye Feel Good

    Time frame: 1 week

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

  19. Subjective Questionnaire Response - Eye Feel Relaxed

    Time frame: 1 week

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

  20. Subjective Questionnaire Response - Vision

    Time frame: 1 week

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

  21. Subjective Questionnaire Response - Eye Tired

    Time frame: 1 week

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

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

Dispensing Study for The Phenacite Project

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 30, 2015
Registry last updated
Dec 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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