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.

Study Overview

• Status: Completed
• Conditions: Myopia
• Intervention / Treatment: Device: Single Vision Spectacle for Vision Correction; Other: Personal Facemask; Device: somofilcon A Daily Disposable Contact Lens

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Manchester, United Kingdom, M13 9PL
    • Eurolens Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. They are aged between 18 and 40 years.
2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They are a 'neophyte' (i.e. someone who has not worn contact lenses previously, with the exception for the purposes of a trial fitting).
5. They have a contact lens spherical prescription between +8.00D and -10.00D (inclusive) based on the ocular refraction.
6. They have a cylindrical correction of -0.75DC or less in each eye based on the ocular refraction.
7. They own and habitually wear single vision spectacles.
8. They are willing to be fitted with contact lenses and understand they may be randomised to either group.
9. They are willing to wear the contact lenses (if relevant) or spectacles for at least 8 hours per day, 5 days per week.
10. 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.
11. They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses (if relevant) or spectacles.
12. They agree to not participate in other clinical research while enrolled on this study.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens
2. wear.
3. They have a systemic disorder which would normally contra-indicate contact lens wear.
4. They are using any topical medication such as eye drops or ointment.
5. They have had cataract surgery.
6. They have had corneal refractive surgery.
7. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
8. They are pregnant or breastfeeding.
9. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
10. 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.
11. They require significant ocular/face personal protective equipment beyond a personal face mask.
12. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
13. They have spectacles which are not within ±0.50D of their refractive error.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Single Vision Spectacle for Vision correction; Single Vision Spectacle	Device: Single Vision Spectacle for Vision Correction; Single Vision Spectacle; Other: Personal Facemask; Personal Facemask
EXPERIMENTAL: somofilcon A Daily disposable contact lenses; Daily disposable contact lenses	Other: Personal Facemask; Personal Facemask; Device: somofilcon A Daily Disposable Contact Lens; Daily Disposable Contact Lens

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Carole Maldonado-Codina, Eurolens Research

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2020
• Primary Completion (ACTUAL): April 15, 2021
• Study Completion (ACTUAL): April 30, 2021

Study Registration Dates

• First Submitted: December 1, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (ESTIMATE): December 8, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 20, 2021
• Last Update Submitted That Met QC Criteria: September 22, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: C20-688 (EX-MKTG-120)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes