Skip to main content
OpenTrials
Completed

NCT Number: NCT04005885

A Clinical Comparison of Two Daily Disposable Soft Contact Lenses

This double-masked, randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eurolens Research - The University of Manchester

Manchester, M13 9PL, United Kingdom

About this study

This double-masked (subject and investigator), randomized, bilateral, crossover, direct refit study compared the clinical performance of two daily disposable test contact lenses (somofilcon A and stenfilcon A) when fitted to existing wearers of comfilcon A monthly lenses. After a month of re-useable lens wear in the comfilcon A lenses, subjects were randomized to wear each daily disposable lens type for one week.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects will only be eligible for the study if:
  • They are between 18 and 40 years of age (inclusive).
  • They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
  • They are willing and able to follow the protocol.
  • They are an existing soft reusable spherical contact lens wearer in both eyes.
  • They have a contact lens spherical prescription between -0.50 to -6.00D (inclusive) based on the ocular refraction.
  • They have a cylindrical correction of -0.875DC or less in each eye based on the ocular refraction
  • They own a wearable pair of spectacles and wear them on the day of the initial visit.
  • They have distance high contrast logMAR visual acuity of 0.2 or better in each eye with their habitual spectacles.
  • They agree not to participate in other clinical research for the duration of the study.

Exclusion criteria

  • They have an ocular disorder which would normally contra-indicate contact lens wear.
  • They have a systemic disorder which would normally contra-indicate contact lens wear.
  • They are using any topical medication such as eye drops or ointment.
  • They are aphakic.
  • They have had corneal refractive surgery.
  • They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
  • They are pregnant or breastfeeding.
  • They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
  • They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.

Treatment and study plan

comfilcon A

Device

Contact Lens

Other names: Control Lens

somofilcon A

Device

daily disposable contact lens

Other names: somofilcon A daily disposable test lens, Test lens 1

stenfilcon A

Device

daily disposable contact lens

Other names: stenfilcon A daily disposable test lens, Test lens 2

Primary outcomes

  1. Subjective Scores of Comfort at Insertion After 4 Weeks of Comfilcon A Use

    Time frame: 4 weeks

    Subjective Scores of comfort at Insertion after 4 weeks of Comfilcon A use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

  2. Subjective Scores of Comfort on Insertion

    Time frame: 1 week

    Subjective Scores of Comfort on Insertion rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

Secondary outcomes

  1. Subjective Scores on Overall Comfort After 4 Weeks of Comfilcon Use

    Time frame: 4 weeks

    Subjective scores on overall comfort after 4 weeks of comfilcon use rated on a scale 0 -100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

  2. Subjective Scores on Overall Comfort

    Time frame: 1 week

    Subjective Scores on overall comfort rated on a scale 0 - 100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

  3. Subjective Scores on Comfort Before Removal After 4 Weeks of Comfilcon Use

    Time frame: 4 weeks

    Subjective Scores on Comfort before removal after 4 weeks of comfilcon use rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

  4. Subjective Scores on Comfort Before Removal

    Time frame: 1 week

    Subjective Scores on Comfort before removal rated on a scale 0-100 (0=causes pain, cannot be tolerated, 100=excellent, cannot be felt).

  5. Number of Participants With Horizontal Lens Centration Grade

    Time frame: Baseline (after 5 minutes of lens dispense)

    Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)

  6. Number of Participants With Horizontal Lens Centration Grade After 4 Weeks of Comfilcon A Wear

    Time frame: 4 weeks

    Number of Participants with Horizontal lens centration after 4 weeks of comfilcon A wear graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)

  7. Number of Participants With Horizontal Lens Centration Grade

    Time frame: 1 week

    Number of Participants with Horizontal Lens centration graded on scale of -2 to 2 ( -2= Extremely nasal, -1 slightly nasal, 0=optimum, 1=slightly temporal, 2=extremely temporal)

  8. Number of Participants With Vertical Lens Centration Grade

    Time frame: Baseline (After 5 minutes of lens dispense)

    Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)

  9. Number of Participants With Vertical Lens Centration Grade After 4 Weeks of Comfilcon A Wear

    Time frame: 4 weeks

    Number of Participants with Vertical lens centration after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)

  10. Number of Participants With Vertical Lens Centration Grade

    Time frame: 1 week

    Number of Participants with Vertical lens centration graded on a scale of -2 to 2 ( -2= Extremely inferior, -1 slightly inferior, 0=optimum, 1=slightly superior, 2=extremely superior)

  11. Number of Participants With Lens Corneal Coverage Grade

    Time frame: Baseline (after 5 minutes of lens dispense)

    Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)

  12. Number of Participants With Lens Corneal Coverage Grade After 4 Weeks of Comfilcon A Wear

    Time frame: 4 weeks

    Number of Participants with Lens Corneal coverage after 4 weeks of comfilcon A wear graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)

  13. Number of Participants With Lens Corneal Coverage Grade

    Time frame: 1 week

    Number of Participants with Lens Corneal coverage graded on a scale -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)

  14. Number of Participants With Post-Blink Movement Grade

    Time frame: Baseline (after 5 minutes of lens dispense)

    Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)

  15. Number of Participants With Post-Blink Movement Grade After 4 Weeks of Comfilcon A Wear

    Time frame: 4 weeks

    Number of Participants with Post-blink movement after 4 weeks of comfilcon A wear graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)

  16. Number of Participants With Post-Blink Movement Grade

    Time frame: 1 week

    Number of Participants with Post-blink movement graded on a scale of -2 to 2 ( -2=extremely inadequate, -1=slightly inadequate, but acceptable, 0=optimum, 1=slightly excessive, but acceptable, 2=extremely excessive)

  17. Investigator Lens Fit Acceptance

    Time frame: Baseline (after 5 minutes of lens dispense)

    Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)

  18. Investigator Lens Fit Acceptance for Comfilcon A After 4 Weeks of Use

    Time frame: 4 weeks

    Lens fit acceptance investigator rating for comfilcon A after 4 weeks of use for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)

  19. Investigator Lens Fit Acceptance

    Time frame: 1 week

    Lens fit acceptance investigator rating for acceptable and optimum fits on 1-5 Likert Scale (1=strongly agree, 2- Agree. 3- Neither agree not disagree, 4- Disagree, 5=strongly disagree)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 2, 2019
Registry last updated
Jan 5, 2021

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.