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Completed

NCT Number: NCT03471832

Clinical Evaluation of Stenfilcon A Contact Lenses

This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control).

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shioya Eye Clinic, Fukushima, Japan

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About this study

This study is to evaluate the fitting performance of stenfilcon A contact lens (test) compared to narafilcon A contact lens (control) over 3 hour of wear time in a Japanese population.

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:

  • Is Japanese
  • Has had a self-reported oculo-visual examination in the last two years.
  • Is at least 18 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 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
  • Currently wears soft contact lenses.
  • Has clear corneas and no active ocular disease.

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

stenfilcon A lens

Device

contact lens

Other names: MyDay, test

narafilcon A lens

Device

contact lens

Other names: 1-day Acuvue TruEye, control

Primary outcomes

  1. Lens Movement

    Time frame: 5 minutes

    Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)

  2. Lens Movement

    Time frame: 3hrs

    Movement of lens after blink: (Categories = Tight, Slightly tight, Optimum, Slightly loose, Loose)

  3. Horizontal Lens Centration

    Time frame: 5 minutes

    Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)

  4. Horizontal Lens Centration

    Time frame: 3hrs

    Centration of lens horizontally: (Grades = Temporal, Slightly temporal, Centered, Slightly Nasal, Nasal)

  5. Vertical Lens Centration

    Time frame: 5 minutes

    Centration of lens horizontally: (Grades = Superior, Slightly superior, Center, Slightly inferior, Inferior)

  6. Vertical Lens Centration

    Time frame: 3hrs

    Centration of lens horizontally: (Grades = Superior, Slightly superior, Centered, Slightly inferior, Inferior)

  7. Corneal Coverage

    Time frame: 5 minutes

    Does lens cover the cornea: (Yes, No)

  8. Corneal Coverage

    Time frame: 3hrs

    Does lens cover the cornea: (Yes, No)

  9. Lens Lag

    Time frame: 5 minutes

    Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)

  10. Lens Lag

    Time frame: 3hrs

    Movement after looking right and left: (Grades = Move along with cornea, slight delay, delay)

  11. Overall Fitting Performance

    Time frame: 5 minutes

    Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)

  12. Overall Fitting Performance

    Time frame: 3hrs

    Lens fit performance: (Grades: Optimum, Good, Acceptable, Unacceptable)

  13. Investigator Fit Preference

    Time frame: 5 minutes

    Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)

  14. Investigator Fit Preference

    Time frame: 3hrs

    Lens fit preference: (Grades: Prefer stenfilcon A strongly, Prefer stenfilcon A slightly, Either, Prefer narafilcon A slightly, Prefer narafilcon A strongly)

Secondary outcomes

  1. Comfort

    Time frame: Baseline

    Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))

  2. Comfort

    Time frame: 5 Minutes

    Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))

  3. Comfort

    Time frame: 3 hours

    Subjective comfort: (on a scale of 0-10, 0 (Uncomfortable) - 10 (Comfortable))

  4. Dryness

    Time frame: Baseline

    Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))

  5. Dryness

    Time frame: 5 minutes

    Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))

  6. Dryness

    Time frame: 3 hours

    Subjective dryness: (on a scale of 0-10, 0 (Dry) - 10 (Not dry))

  7. Stinging/Burning

    Time frame: Baseline

    Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))

  8. Stinging/Burning

    Time frame: 5 minutes

    Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))

  9. Stinging/Burning

    Time frame: 3 hours

    Subjective stinging/burning sensation: (on a scale of 0-10, 0 (Cannot wear) - 10 (No Stinging/Burning))

  10. Edge/Lens Awareness

    Time frame: Baseline

    Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))

  11. Edge/Lens Awareness

    Time frame: 5 minutes

    Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))

  12. Edge/Lens Awareness

    Time frame: 3 hours

    Subjective edge/lens awareness: (on a scale of 0-10, 0 (Cannot wear) - 10 (No edge awareness))

  13. Subjective Lens Preference

    Time frame: Baseline

    Lens preference (stenfilcon A, Either, Neither, narafilcon A)

  14. Subjective Lens Preference

    Time frame: 5 minutes

    Lens preference (stenfilcon A, Either, Neither, narafilcon A)

  15. Subjective Lens Preference

    Time frame: 3 hours

    Lens preference (stenfilcon A, Either, Neither, narafilcon A)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Official study title

Clinical Evaluation of CooperVision MyDay Lenses

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 21, 2018
Registry last updated
Jan 29, 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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