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OpenTrials
Completed

NCT Number: NCT02553395

One Week Assessment of The Phenacite Lens

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.

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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

Clinical Optics Research Lab (CORL) Indiana University School of Optometry, Indiana University

Bloomington, Indiana, 47405, United States

About this study

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.

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 (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.

Treatment and study plan

Phenacite (Test) contact lens

Device

Comfilcon A contact lens

Device

Primary outcomes

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

    Time frame: Baseline - After 5 minutes of lens settling

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

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

    Time frame: 1 week

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

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

    Time frame: Baseline - after 5 minutes of lens dispense

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

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

    Time frame: 1-week

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

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

    Time frame: Baseline (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)

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

    Time frame: 1 week

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

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

    Time frame: Baseline (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)

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

    Time frame: 1week

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

  9. Subjective Ratings for Distance Quality of Vision

    Time frame: 1 week

    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)

  10. Subjective Ratings for Intermediate Quality of Vision

    Time frame: 1 week

    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)

  11. Subjective Ratings for Near Quality of Vision

    Time frame: 1 week

    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)

Secondary outcomes

  1. Post Blink Movement -

    Time frame: 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)

  2. Post Blink Movement

    Time frame: 1 week

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

  3. Push - Up Test for Lens Tightness

    Time frame: Baseline (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

  4. Push - Up Test for Lens Tightness

    Time frame: 1 week

    Investigator assessment using Continuous Scale 0-100% (1% steps): 0%=Falls from cornea without lid support, 50%=Optimum, 100%=No movement

  5. Lens Mobility Rating

    Time frame: Baseline (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

  6. Lens Mobility Rating

    Time frame: 1 week

    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

  7. Overall Lens Fit Acceptance

    Time frame: Baseline (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

  8. Overall Lens Fit Acceptance

    Time frame: 1 week

    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

  9. Subjective Lens Preference - Distance Vision

    Time frame: 1 week

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

  10. Subjective Lens Preference -Overall Vision Preference

    Time frame: 1 week

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

  11. Subjective Lens Preference - Comfort

    Time frame: 1 week

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

  12. Subjective Overall Lens Preference

    Time frame: 1 week

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

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 17, 2015
Registry last updated
Dec 22, 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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