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OpenTrials
Completed

NCT Number: NCT04658797

Clinical Evaluation on Using Personal Face Masks With Spectacles Versus Contact Lenses

The aim of this study was to explore satisfaction with vision correction and ease of use of PFM (Personal Face Masks) in a group of spectacle wearers who were randomised to continue wearing spectacles or be fitted with daily disposable contact lenses.

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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

Manchester, M13 9PL, United Kingdom

About this study

This was a two arm parallel-group, randomised study. Subjects wearing single vision spectacles were recruited to participate in the study. Subjects were randomised to either continue to use their spectacles or to be fitted with the study daily disposable (DD) contact lens.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • They are aged between 18 and 40 years.
  • 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 a 'neophyte' (i.e. someone who has not worn contact lenses previously, with the exception for the purposes of a trial fitting).
  • They have a contact lens spherical prescription between +8.00D and -10.00D (inclusive) based on the ocular refraction.
  • They have a cylindrical correction of -0.75DC or less in each eye based on the ocular refraction.
  • They own and habitually wear single vision spectacles.
  • They are willing to be fitted with contact lenses and understand they may be randomised to either group.
  • They are willing to wear the contact lenses (if relevant) or spectacles for at least 8 hours per day, 5 days per week.
  • They are able to wear the supplied surgical masks for the majority of time that they need to wear PFM and will wear the PFM for at least one hour a day for at least four days per week.
  • They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses (if relevant) or spectacles.
  • They agree to not participate in other clinical research while enrolled on this 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 have had cataract surgery.
  • 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 ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
  • 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 require significant ocular/face personal protective equipment beyond a personal face mask.
  • They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
  • They have spectacles which are not within ±0.50D of their refractive error.

Treatment and study plan

somofilcon A Daily Disposable Contact Lens

Device

Daily Disposable Contact Lens

Single Vision Spectacle for Vision Correction

Device

Single Vision Spectacle

Personal Facemask

Other

Personal Facemask

Primary outcomes

  1. Visual Acuity - High Contrast

    Time frame: Baseline

    Visual Acuity under high contrast was measured using logMAR Visual Acuity Chart

  2. Visual Acuity - Low Contrast

    Time frame: Baseline

    Visual Acuity under low contrast was measured using logMAR Visual Acuity Chart

  3. Visual Acuity - High Contrast

    Time frame: 2 weeks

    Visual Acuity under high contrast was measured using logMAR Visual Acuity Chart

  4. Subjective Response on Facemask Usability Questionnaire - Breathability

    Time frame: Baseline

    Subjective response on facemask usability questionnaire - Breathability assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

  5. Subjective Response on Facemask Usability Questionnaire - Breathability

    Time frame: 2 weeks

    Subjective response on facemask usability questionnaire - Breathability assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

  6. Subjective Response on Facemask Usability Questionnaire - Heat

    Time frame: Baseline

    Subjective response on facemask usability questionnaire - Heat assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

  7. Subjective Response on Facemask Usability Questionnaire -Heat

    Time frame: 2 weeks

    Subjective response on facemask usability questionnaire - Heat assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

  8. Subjective Response on Facemask Usability Questionnaire - Tightness

    Time frame: Baseline

    Subjective response on facemask usability questionnaire - Tightness assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

  9. Subjective Response on Facemask Usability Questionnaire -Tightness

    Time frame: 2 weeks

    Subjective response on facemask usability questionnaire - Tightness assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

  10. Subjective Response on Facemask Usability Questionnaire - Ease in Talking

    Time frame: Baseline

    Subjective response on facemask usability questionnaire - Ease in Talking assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

  11. Subjective Response on Facemask Usability Questionnaire -Ease in Talking

    Time frame: 2 weeks

    Subjective response on facemask usability questionnaire - Ease in Talking assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

  12. Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes

    Time frame: Baseline

    Subjective response on facemask usability questionnaire - Comfort on ear lobes assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

  13. Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes

    Time frame: 2 Weeks

    Subjective response on facemask usability questionnaire - Comfort on ear lobes assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

  14. Subjective Response on Facemask Usability Questionnaire - Overall Comfort

    Time frame: Baseline

    Subjective response on facemask usability questionnaire - Overall Comfort assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

  15. Subjective Response on Facemask Usability Questionnaire - Overall Comfort

    Time frame: 2 Weeks

    Subjective response on facemask usability questionnaire - Overall Comfort assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)

  16. Difficulty in Walking When Using Wearing Vision Correction and Facemask

    Time frame: Baseline

    Difficulty in walking when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy).

  17. Difficulty in Walking When Using Wearing Vision Correction and Facemask

    Time frame: 2 Weeks

    Difficulty in walking when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)

  18. Difficulty in Driving When Using Wearing Vision Correction and Facemask

    Time frame: Baseline

    Difficulty in driving when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)

  19. Difficulty in Driving When Using Wearing Vision Correction and Facemask

    Time frame: 2 weeks

    Difficulty in driving when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)

  20. Difficulty in Reading When Using Wearing Vision Correction and Facemask

    Time frame: Baseline

    Difficulty in reading when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)

  21. Difficulty in Reading When Using Wearing Vision Correction and Facemask

    Time frame: 2 weeks

    Difficulty in reading when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)

  22. Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask

    Time frame: Baseline

    Difficulty in working with a computer when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)

  23. Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask

    Time frame: 2 weeks

    Difficulty in working with a computer when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)

  24. Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask

    Time frame: Baseline

    Difficulty in exercising (physical activities)when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)

  25. Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask

    Time frame: 2 weeks

    Difficulty in exercising (physical activities)when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)

  26. Difficulty in Socializing When Using Wearing Vision Correction and Facemask

    Time frame: Baseline

    Difficulty in socializing when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)

  27. Difficulty in Socializing When Using Wearing Vision Correction and Facemask

    Time frame: 2 weeks

    Difficulty in socializing when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)

  28. Physical Safety Concerns When Wearing Your Vision Correction and Facemask

    Time frame: Baseline

    Physical safety concerns when wearing your vision correction and facemask assessed on a scale of 1-5 (1- Extremely concerned, 2 - Moderately concerned, 3- Somewhat concerned, 4 -Slightly concerned, 5- Not at all concerned)

  29. Physical Safety Concerns When Wearing Your Vision Correction and Facemask

    Time frame: 2 weeks

    Physical safety concerns when wearing your vision correction and facemask assessed on a scale of 1-5 (1- Extremely concerned, 2 - Moderately concerned, 3- Somewhat concerned, 4 -Slightly concerned, 5- Not at all concerned)

  30. Emotional Impact of Using the Facemask When Wearing Your Vision Correction

    Time frame: Baseline

    Emotional impact of using the facemask when wearing your vision correction assessed on a scale of 1-5 (1- Severe, 2- Major, 3- Moderate, 4- Minor, 5- Insignificant)

  31. Emotional Impact of Using the Facemask When Wearing Your Vision Correction

    Time frame: 2 weeks

    Emotional impact of using the facemask when wearing your vision correction assessed on a scale of 1-5 (1- Severe, 2- Major, 3- Moderate, 4- Minor, 5- Insignificant)

  32. Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction

    Time frame: Baseline

    Impact of using the facemask on your personal appearance when wearing your vision correction assessed on a scale of 1-5 (1- Severe, 2- Major, 3- Moderate, 4- Minor, 5- Insignificant)

  33. Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction

    Time frame: 2 weeks

    Impact of using the facemask on your personal appearance when wearing your vision correction assessed on a scale of 1-5 (1- Severe, 2- Major, 3- Moderate, 4- Minor, 5- Insignificant)

Sponsors and collaborators

Lead sponsor

CooperVision, Inc.

Industry

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 8, 2020
Registry last updated
Oct 20, 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.

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