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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Myopia

Intervention / Treatment
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* Device: somofilcon A Daily Disposable Contact Lens
* Device: Single Vision Spectacle for Vision Correction
* Other: Personal Facemask


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single Vision Spectacle for Vision correction<br>Single Vision Spectacle | Device: Single Vision Spectacle for Vision Correction<br>* Single Vision Spectacle<br>Other: Personal Facemask<br>* Personal Facemask<br>|
| Experimental: somofilcon A Daily disposable contact lenses<br>Daily disposable contact lenses | Device: somofilcon A Daily Disposable Contact Lens<br>* Daily Disposable Contact Lens<br>Other: Personal Facemask<br>* Personal Facemask<br>|

What is the study measuring?
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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 |