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

NCT04658797 | Completed Results DMC FDA Device

• 1 other identifier: C20-688 (EX-MKTG-120)
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (33)

• Visual Acuity - High Contrast

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

  Baseline

• Visual Acuity - Low Contrast

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

  Baseline

• Visual Acuity - High Contrast

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

  2 weeks

• Subjective Response on Facemask Usability Questionnaire - Breathability

  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)

  Baseline

• Subjective Response on Facemask Usability Questionnaire - Breathability

  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)

  2 weeks

• Subjective Response on Facemask Usability Questionnaire - Heat

  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)

  Baseline

• Subjective Response on Facemask Usability Questionnaire -Heat

  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)

  2 weeks

• Subjective Response on Facemask Usability Questionnaire - Tightness

  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)

  Baseline

• Subjective Response on Facemask Usability Questionnaire -Tightness

  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)

  2 weeks

• Subjective Response on Facemask Usability Questionnaire - Ease in Talking

  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)

  Baseline

• Subjective Response on Facemask Usability Questionnaire -Ease in Talking

  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)

  2 weeks

• Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes

  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)

  Baseline

• Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes

  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)

  2 Weeks

• Subjective Response on Facemask Usability Questionnaire - Overall Comfort

  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)

  Baseline

• Subjective Response on Facemask Usability Questionnaire - Overall Comfort

  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)

  2 Weeks

• Difficulty in Walking When Using Wearing Vision Correction and Facemask

  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).

  Baseline

• Difficulty in Walking When Using Wearing Vision Correction and Facemask

  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)

  2 Weeks

• Difficulty in Driving When Using Wearing Vision Correction and Facemask

  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)

  Baseline

• Difficulty in Driving When Using Wearing Vision Correction and Facemask

  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)

  2 weeks

• Difficulty in Reading When Using Wearing Vision Correction and Facemask

  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)

  Baseline

• Difficulty in Reading When Using Wearing Vision Correction and Facemask

  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)

  2 weeks

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

  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)

  Baseline

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

  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)

  2 weeks

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

  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)

  Baseline

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

  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)

  2 weeks

• Difficulty in Socializing When Using Wearing Vision Correction and Facemask

  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)

  Baseline

• Difficulty in Socializing When Using Wearing Vision Correction and Facemask

  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)

  2 weeks

• Physical Safety Concerns When Wearing Your Vision Correction and Facemask

  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)

  Baseline

• Physical Safety Concerns When Wearing Your Vision Correction and Facemask

  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)

  2 weeks

• Emotional Impact of Using the Facemask When Wearing Your Vision Correction

  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)

  Baseline

• Emotional Impact of Using the Facemask When Wearing Your Vision Correction

  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)

  2 weeks

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

  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)

  Baseline

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

  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)

  2 weeks

Study Arms (2)

Single Vision Spectacle for Vision correction

ACTIVE COMPARATOR

Single Vision Spectacle

Device: Single Vision Spectacle for Vision Correction; Other: Personal Facemask

somofilcon A Daily disposable contact lenses

EXPERIMENTAL

Daily disposable contact lenses

Device: somofilcon A Daily Disposable Contact Lens; Other: Personal Facemask

Interventions

somofilcon A Daily Disposable Contact Lens DEVICE

Daily Disposable Contact Lens

somofilcon A Daily disposable contact lenses

Single Vision Spectacle for Vision Correction DEVICE

Single Vision Spectacle

Single Vision Spectacle for Vision correction

Personal Facemask OTHER

Personal Facemask

Single Vision Spectacle for Vision correction; somofilcon A Daily disposable contact lenses

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CooperVision, Inc.: lead

Study Sites (1)

Eurolens Research

Manchester, M13 9PL, United Kingdom

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Jose Vega, OD, MSc, FAAO
• Organization: CooperVision, Inc

JVega2@coopervision.com

9256213761

Study Officials

• Carole Maldonado-Codina

  Eurolens Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2020
• First Posted: December 8, 2020
• Study Start: November 1, 2020
• Primary Completion: April 15, 2021
• Study Completion: April 30, 2021
• Last Updated: October 20, 2021
• Results First Posted: October 20, 2021

Record last verified: 2021-09

Locations

GB (1)