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Completed

NCT Number: NCT03024970

Daily Disposable Dispensing Clinical Trial of Test Lens Against Stenfilcon A Lens

The purpose of this study is to investigate the overall clinical performance of the test daily disposable stenfilcon A lens with solution additive (test) compared to the stenfilcon A 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

Clinical Optical Research Lab (CORL), Bloomington, Indiana, United States

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About this study

This will be, prospective, multicenter, double-masked, randomized, bilateral, 1 month cross-over, dispensing study comparing the test lens against the stenfilcon A control lens with a study duration of approximately two months.

Each subject will be randomized to wear either the test or control as a matched pair first and subjects will be randomized based on the order in which the subject is enrolled and qualified into the study.

Who can participate

Healthy volunteers accepted: Yes

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:
  • 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 information 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.
  • Must achieve 20/30 or better (in each eye) with study lenses
  • Requires spectacle lens powers between -0.75 and -6.50 diopters sphere (0.25D steps).
  • Has no more than 0.75 diopters of refractive astigmatism.
  • Currently wears soft contact lenses.
  • Have clear corneas and no active ocular disease.
  • Has not worn lenses for at least 12 hours before the examination

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 pregnant, lactating, or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
  • Have taken part in any other contact lens or care solution clinical trial or research, within one week prior to starting this study.

Treatment and study plan

stenfilcon A lens with solution additive (test)

Device

silicone hydrogel lens

stenfilcon A lens (control)

Device

contact lens

Primary outcomes

  1. Subjective Ratings on Comfort

    Time frame: Baseline

    Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable

  2. Subjective Ratings on Comfort

    Time frame: 1 Week

    Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable

  3. Subjective Ratings on Comfort

    Time frame: 1 Month

    Subjects assessed comfort for test and control lens on a scale 0-10, 0=not comfortable 10=comfortable

  4. Vision Satisfaction

    Time frame: Baseline

    Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree

  5. Vision Satisfaction

    Time frame: 1 week

    Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree

  6. Vision Satisfaction

    Time frame: 1 Month

    Subjective ratings on vision satisfaction was assessed for test and control lens using a 5- point Likert scale: 1- Strongly disagree, 2- disagree, 3- neutral, 4- agree, 5- strongly agree

  7. Visual Acuity On High Illumination High Contrast

    Time frame: Baseline

    Visual acuity is assessed on high illumination high contrast logMAR charts for test and control lenses. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.

  8. Visual Acuity On High Illumination High Contrast

    Time frame: 1 Week

    Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.

  9. Visual Acuity On High Illumination High Contrast

    Time frame: 1 Month

    Visual acuity is assessed on high illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.

  10. Visual Acuity On Low Illumination High Contrast

    Time frame: Baseline

    Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.

  11. Visual Acuity On Low Illumination High Contrast

    Time frame: 1 Week

    Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.

  12. Visual Acuity On Low Illumination High Contrast

    Time frame: 1 Month

    Visual acuity is assessed on low illumination high contrast for test and control lens by LogMAR. Visual acuity of logMar of 0.0 is equivalent to 20/20 of Snellen. Each 0.1 addition in logMar is 1 line in Snellen chart.

  13. Overall Corneal Staining

    Time frame: One Week

    Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.

  14. Overall Corneal Staining

    Time frame: One Month

    Overall corneal staining is assessed for test and control lens in a scale of 0-4, 0=No staining,1=trace, 2=mild, 3=moderate, 4=Severe.

  15. Conjunctival Staining

    Time frame: 1 Week

    Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent

  16. Conjunctival Staining

    Time frame: 1 Month

    Conjunctival staining is assessed for test and control lens in 0.50 steps. Scale 0-4, 0=None, 4= Deep confluent

  17. Bulbar Hyperemia

    Time frame: 1 Week

    Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

  18. Bulbar Hyperemia

    Time frame: 1 Month

    Bulbar hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

  19. Limbal Hyperemia

    Time frame: 1 Week

    Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

  20. Limbal Hyperemia

    Time frame: 1 Month

    Limbal hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

  21. Palpebral Hyperemia

    Time frame: 1 Week

    Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

  22. Palpebral Hyperemia

    Time frame: 1 Month

    Palpebral hyperemia is assessed for test and control lens on a scale of 0-4,0.25 steps. (0=None, 1=Slight injection of conjunctival vessels, 2=Mild injection, 3=Moderate injection, 4=Severe injection)

Secondary outcomes

  1. Lens Fit Acceptance

    Time frame: Baseline

    Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.

  2. Lens Fit Acceptance

    Time frame: 1 week

    Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.

  3. Lens Fit Acceptance

    Time frame: 1 Month

    Overall fit acceptance is assessed for test and control lens. Scale 0-4, 0=can't be worn, 1=Poor, 2=Fair, 3=Good, 4=optimum.

  4. Handling Satisfaction

    Time frame: 1 week

    Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree

  5. Handling Satisfaction

    Time frame: 1 Month

    Handling satisfaction is assessed for test and control lens. 5 point Likert scale: 1- Strongly disagree, 2-disagree, 3-neutral, 4-agree, 5- strongly agree

  6. Lens Surface - Wettability

    Time frame: Baseline

    Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent

  7. Lens Surface - Wettability

    Time frame: 1 Week

    Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent

  8. Lens Surface - Wettability

    Time frame: 1 Month

    Wettability is assessed for test and control lens on a scale of 0-4, 0=Very poor, 4=Excellent

  9. Lens Surface - Deposits

    Time frame: Baseline

    Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.

  10. Lens Surface - Deposits

    Time frame: 1 week

    Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.

  11. Lens Surface - Deposits

    Time frame: 1 Month

    Deposits are assessed for test and control lens. Scale 0-4, 0.25 steps. 0=Clean, no deposits, 4=Deposits of 0.5mm or larger or film covering more than 75% of surface.

  12. Subjective Ratings on Dryness

    Time frame: Baseline

    Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry

  13. Subjective Ratings on Dryness

    Time frame: 1 week

    Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry

  14. Subjective Ratings on Dryness

    Time frame: 1 Month

    Subjective ratings on dryness is assessed for test and control lens on a scale of 0-10, 0=dry, 10=not dry

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jan 19, 2017
Registry last updated
Jul 21, 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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