Myopia
Conditions
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.
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.
Interventions
DEVICEsomofilcon A Daily Disposable Contact Lens
Daily Disposable Contact Lens
DEVICESingle Vision Spectacle for Vision Correction
Single Vision Spectacle
OTHERPersonal Facemask
Personal Facemask
Sponsors
CooperVision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Acuity - High Contrast | Baseline | Visual Acuity under high contrast was measured using logMAR Visual Acuity Chart |
| Visual Acuity - Low Contrast | Baseline | Visual Acuity under low contrast was measured using logMAR Visual Acuity Chart |
| Subjective Response on Facemask Usability Questionnaire - Breathability | 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) |
| Subjective Response on Facemask Usability Questionnaire - Heat | 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) |
| Subjective Response on Facemask Usability Questionnaire -Heat | 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) |
| Subjective Response on Facemask Usability Questionnaire - Tightness | 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) |
| Subjective Response on Facemask Usability Questionnaire -Tightness | 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) |
| Subjective Response on Facemask Usability Questionnaire - Ease in Talking | 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) |
| Subjective Response on Facemask Usability Questionnaire -Ease in Talking | 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) |
| Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | 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) |
| Subjective Response on Facemask Usability Questionnaire - Overall Comfort | 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) |
| Difficulty in Walking When Using Wearing Vision Correction and Facemask | 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). |
| Difficulty in Driving When Using Wearing Vision Correction and Facemask | 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) |
| Difficulty in Reading When Using Wearing Vision Correction and Facemask | 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) |
| Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | 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) |
| Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | 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) |
| Difficulty in Socializing When Using Wearing Vision Correction and Facemask | 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) |
| Physical Safety Concerns When Wearing Your Vision Correction and Facemask | 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) |
| Emotional Impact of Using the Facemask When Wearing Your Vision Correction | 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) |
| Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | 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) |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Vision Spectacle for Vision Correction Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask. | 15 |
| Somofilcon A Daily Disposable Contact Lenses Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. | 15 |
| Total | 30 |
Baseline characteristics
| Characteristic | Somofilcon A Daily Disposable Contact Lenses | Total | Single Vision Spectacle for Vision Correction |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 30 Participants | 15 Participants |
| Age, Continuous | 27.4 years STANDARD_DEVIATION 5.8 | 26.5 years STANDARD_DEVIATION 5.6 | 25.5 years STANDARD_DEVIATION 5.3 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United Kingdom | 15 participants | 30 participants | 15 participants |
| Sex: Female, Male Female | 11 Participants | 22 Participants | 11 Participants |
| Sex: Female, Male Male | 4 Participants | 8 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 15 |
| other Total, other adverse events | 0 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 15 |
Outcome results
Primary
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)
Time frame: Baseline
Population: 10 subjects from somofilcon A Daily disposable contact lenses and 6 subjects from Single Vision Spectacle for Vision correction didn't drive with their face mask and didn't answer the question.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Easy | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Difficult | 2 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Neutral | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Very difficult | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Very easy | 0 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Very difficult | 3 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Very easy | 0 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Easy | 1 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Neutral | 3 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Difficult | 2 Participants |
Primary
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)
Time frame: 2 weeks
Population: 11 subjects from somofilcon A Daily disposable contact lenses and 7 subjects from Single Vision Spectacle for Vision correction didn't drive with their face mask and didn't answer the question.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Easy | 1 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Difficult | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Neutral | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Very Difficult | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Very Easy | 3 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Very Difficult | 3 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Very Easy | 0 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Easy | 2 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Neutral | 2 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Driving When Using Wearing Vision Correction and Facemask | Difficult | 1 Participants |
Primary
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)
Time frame: 2 weeks
Population: 2 subjects from somofilcon A Daily disposable contact lenses and 3 subjects from Single Vision Spectacle for Vision correction didn't exercise with facemask and didn't answer the question.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Easy | 4 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Difficult | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Neutral | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Very Difficult | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Very Easy | 6 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Very Difficult | 3 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Very Easy | 0 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Easy | 0 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Neutral | 0 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Difficult | 9 Participants |
Primary
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)
Time frame: Baseline
Population: 7 subjects from somofilcon A Daily disposable contact lenses and 4 subjects from Single Vision Spectacle for Vision correction didn't exercise with facemask and didn't answer the question.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Easy | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Difficult | 2 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Neutral | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Very difficult | 6 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Very easy | 0 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Very difficult | 4 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Very easy | 0 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Easy | 0 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Neutral | 0 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask | Difficult | 7 Participants |
Primary
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)
Time frame: 2 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Easy | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Difficult | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Neutral | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Very difficult | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Very easy | 9 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Very difficult | 2 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Very easy | 2 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Easy | 4 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Neutral | 3 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Difficult | 4 Participants |
Primary
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)
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Easy | 1 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Difficult | 7 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Neutral | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Very difficult | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Very easy | 1 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Very difficult | 1 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Very easy | 2 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Easy | 2 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Neutral | 6 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Reading When Using Wearing Vision Correction and Facemask | Difficult | 4 Participants |
Primary
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)
Time frame: 2 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Easy | 5 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Neutral | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Difficult | 1 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Very difficult | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Very easy | 6 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Very difficult | 2 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Very easy | 2 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Easy | 2 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Difficult | 4 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Neutral | 5 Participants |
Primary
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)
Time frame: Baseline
Population: 1 subject from somofilcon A Daily disposable contact lenses didn't answer the question.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Easy | 2 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Neutral | 4 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Difficult | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Very Difficult | 5 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Very Easy | 0 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Very Difficult | 2 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Very Easy | 2 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Easy | 2 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Difficult | 4 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Socializing When Using Wearing Vision Correction and Facemask | Neutral | 5 Participants |
Primary
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).
Time frame: Baseline
Population: One subject from somofilcon A Daily disposable contact lenses didn't answer questionnaire.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Easy | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Difficult | 4 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Neutral | 2 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Very difficult | 4 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Very easy | 1 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Very difficult | 1 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Very easy | 3 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Easy | 1 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Neutral | 4 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Difficult | 6 Participants |
Primary
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)
Time frame: 2 Weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Easy | 4 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Difficult | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Neutral | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Very difficult | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Very easy | 11 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Very difficult | 1 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Very easy | 3 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Easy | 3 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Neutral | 3 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Walking When Using Wearing Vision Correction and Facemask | Difficult | 5 Participants |
Primary
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)
Time frame: 2 weeks
Population: 1 subject from somofilcon A Daily disposable contact lenses didn't answer the question.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Easy | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Difficult | 1 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Neutral | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Very difficult | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Very easy | 7 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Very difficult | 2 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Very easy | 3 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Easy | 3 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Neutral | 3 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Difficult | 4 Participants |
Primary
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)
Time frame: Baseline
Population: 3 subjects from somofilcon A Daily disposable contact lenses didn't answer the question.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Easy | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Difficult | 8 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Neutral | 1 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Very difficult | 2 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Very easy | 1 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Very difficult | 1 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Very easy | 1 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Easy | 3 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Neutral | 4 Participants |
| Single Vision Spectacle for Vision Correction | Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask | Difficult | 6 Participants |
Primary
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)
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Minor | 6 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Major | 1 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Moderate | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Severe | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Insignificant | 5 Participants |
| Single Vision Spectacle for Vision Correction | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Severe | 0 Participants |
| Single Vision Spectacle for Vision Correction | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Insignificant | 7 Participants |
| Single Vision Spectacle for Vision Correction | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Minor | 6 Participants |
| Single Vision Spectacle for Vision Correction | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Moderate | 2 Participants |
| Single Vision Spectacle for Vision Correction | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Major | 0 Participants |
Primary
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)
Time frame: 2 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Minor | 6 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Major | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Moderate | 1 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Severe | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Insignificant | 8 Participants |
| Single Vision Spectacle for Vision Correction | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Severe | 0 Participants |
| Single Vision Spectacle for Vision Correction | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Insignificant | 6 Participants |
| Single Vision Spectacle for Vision Correction | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Minor | 6 Participants |
| Single Vision Spectacle for Vision Correction | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Moderate | 3 Participants |
| Single Vision Spectacle for Vision Correction | Emotional Impact of Using the Facemask When Wearing Your Vision Correction | Major | 0 Participants |
Primary
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)
Time frame: 2 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Minor | 6 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Major | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Moderate | 2 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Severe | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Insignificant | 7 Participants |
| Single Vision Spectacle for Vision Correction | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Severe | 1 Participants |
| Single Vision Spectacle for Vision Correction | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Insignificant | 3 Participants |
| Single Vision Spectacle for Vision Correction | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Minor | 8 Participants |
| Single Vision Spectacle for Vision Correction | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Moderate | 3 Participants |
| Single Vision Spectacle for Vision Correction | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Major | 0 Participants |
Primary
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)
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Minor | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Major | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Moderate | 4 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Severe | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Insignificant | 5 Participants |
| Single Vision Spectacle for Vision Correction | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Severe | 1 Participants |
| Single Vision Spectacle for Vision Correction | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Insignificant | 2 Participants |
| Single Vision Spectacle for Vision Correction | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Minor | 6 Participants |
| Single Vision Spectacle for Vision Correction | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Moderate | 3 Participants |
| Single Vision Spectacle for Vision Correction | Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction | Major | 3 Participants |
Primary
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)
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Slightly concerned | 1 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Moderately concerned | 5 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Somewhat concerned | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Extremely concerned | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Not at all concerned | 6 Participants |
| Single Vision Spectacle for Vision Correction | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Extremely concerned | 0 Participants |
| Single Vision Spectacle for Vision Correction | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Not at all concerned | 9 Participants |
| Single Vision Spectacle for Vision Correction | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Slightly concerned | 3 Participants |
| Single Vision Spectacle for Vision Correction | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Somewhat concerned | 1 Participants |
| Single Vision Spectacle for Vision Correction | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Moderately concerned | 2 Participants |
Primary
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)
Time frame: 2 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Slightly concerned | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Moderately concerned | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Somewhat concerned | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Extremely concerned | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Not at all concerned | 12 Participants |
| Single Vision Spectacle for Vision Correction | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Extremely concerned | 1 Participants |
| Single Vision Spectacle for Vision Correction | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Not at all concerned | 9 Participants |
| Single Vision Spectacle for Vision Correction | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Slightly concerned | 3 Participants |
| Single Vision Spectacle for Vision Correction | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Somewhat concerned | 1 Participants |
| Single Vision Spectacle for Vision Correction | Physical Safety Concerns When Wearing Your Vision Correction and Facemask | Moderately concerned | 1 Participants |
Primary
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)
Time frame: 2 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Breathability | Satisfactory | 5 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Breathability | Unsatisfactory | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Breathability | Average | 5 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Breathability | very unsatisfactory | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Breathability | Very Satisfactory | 5 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Breathability | very unsatisfactory | 1 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Breathability | Very Satisfactory | 1 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Breathability | Satisfactory | 5 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Breathability | Average | 6 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Breathability | Unsatisfactory | 2 Participants |
Primary
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)
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Breathability | Satisfactory | 4 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Breathability | Unsatisfactory | 4 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Breathability | Average | 5 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Breathability | very unsatisfactory | 1 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Breathability | Very Satisfactory | 1 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Breathability | very unsatisfactory | 0 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Breathability | Very Satisfactory | 2 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Breathability | Satisfactory | 5 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Breathability | Average | 6 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Breathability | Unsatisfactory | 2 Participants |
Primary
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)
Time frame: 2 Weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Satisfactory | 5 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Unsatisfactory | 1 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Average | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Very unsatisfactory | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Very satisfactory | 6 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Very unsatisfactory | 0 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Very satisfactory | 4 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Satisfactory | 6 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Average | 2 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Unsatisfactory | 3 Participants |
Primary
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)
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Satisfactory | 2 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Unsatisfactory | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Average | 1 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Very unsatisfactory | 1 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Very satisfactory | 8 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Very unsatisfactory | 0 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Very satisfactory | 3 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Satisfactory | 7 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Average | 2 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes | Unsatisfactory | 3 Participants |
Primary
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)
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Ease in Talking | Satisfactory | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Ease in Talking | Unsatisfactory | 5 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Ease in Talking | Average | 4 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Ease in Talking | Very unsatisfactory | 1 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Ease in Talking | Very satisfactory | 2 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Ease in Talking | Very unsatisfactory | 0 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Ease in Talking | Very satisfactory | 1 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Ease in Talking | Satisfactory | 6 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Ease in Talking | Average | 5 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Ease in Talking | Unsatisfactory | 3 Participants |
Primary
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)
Time frame: 2 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire -Ease in Talking | Satisfactory | 4 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire -Ease in Talking | Unsatisfactory | 4 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire -Ease in Talking | Average | 4 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire -Ease in Talking | Very unsatisfactory | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire -Ease in Talking | Very satisfactory | 3 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire -Ease in Talking | Very unsatisfactory | 0 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire -Ease in Talking | Very satisfactory | 1 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire -Ease in Talking | Satisfactory | 4 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire -Ease in Talking | Average | 6 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire -Ease in Talking | Unsatisfactory | 4 Participants |
Primary
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)
Time frame: 2 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire -Heat | Satisfactory | 6 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire -Heat | Unsatisfactory | 2 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire -Heat | Average | 4 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire -Heat | very unsatisfactory | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire -Heat | Very Satisfactory | 3 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire -Heat | very unsatisfactory | 1 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire -Heat | Very Satisfactory | 1 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire -Heat | Satisfactory | 2 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire -Heat | Average | 4 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire -Heat | Unsatisfactory | 7 Participants |
Primary
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)
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Heat | Satisfactory | 2 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Heat | Unsatisfactory | 8 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Heat | Average | 3 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Heat | very unsatisfactory | 1 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Heat | Very Satisfactory | 1 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Heat | very unsatisfactory | 1 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Heat | Very Satisfactory | 0 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Heat | Satisfactory | 6 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Heat | Average | 4 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Heat | Unsatisfactory | 4 Participants |
Primary
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)
Time frame: 2 Weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Satisfactory | 6 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Unsatisfactory | 1 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Average | 5 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Very unsatisfactory | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Very satisfactory | 3 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Very unsatisfactory | 2 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Very satisfactory | 0 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Satisfactory | 4 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Average | 7 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Unsatisfactory | 2 Participants |
Primary
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)
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Satisfactory | 2 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Unsatisfactory | 4 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Average | 8 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Very unsatisfactory | 1 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Very satisfactory | 0 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Very unsatisfactory | 0 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Very satisfactory | 0 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Satisfactory | 5 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Average | 10 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Overall Comfort | Unsatisfactory | 0 Participants |
Primary
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)
Time frame: 2 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire -Tightness | Satisfactory | 7 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire -Tightness | Unsatisfactory | 1 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire -Tightness | Very satisfactory | 4 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire -Tightness | Very unsatisfactory | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire -Tightness | Average | 3 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire -Tightness | Very unsatisfactory | 0 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire -Tightness | Very satisfactory | 0 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire -Tightness | Satisfactory | 10 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire -Tightness | Average | 5 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire -Tightness | Unsatisfactory | 0 Participants |
Primary
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)
Time frame: Baseline
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Tightness | Satisfactory | 7 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Tightness | Unsatisfactory | 2 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Tightness | Average | 4 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Tightness | Very unsatisfactory | 0 Participants |
| Somofilcon A Daily Disposable Contact Lenses | Subjective Response on Facemask Usability Questionnaire - Tightness | Very satisfactory | 2 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Tightness | Very unsatisfactory | 0 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Tightness | Very satisfactory | 2 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Tightness | Satisfactory | 7 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Tightness | Average | 5 Participants |
| Single Vision Spectacle for Vision Correction | Subjective Response on Facemask Usability Questionnaire - Tightness | Unsatisfactory | 1 Participants |
Primary
Visual Acuity - High Contrast
Visual Acuity under high contrast was measured using logMAR Visual Acuity Chart
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Visual Acuity - High Contrast | -0.06 logMAR | Standard Deviation 0.07 |
| Single Vision Spectacle for Vision Correction | Visual Acuity - High Contrast | -0.07 logMAR | Standard Deviation 0.05 |
Primary
Visual Acuity - High Contrast
Visual Acuity under high contrast was measured using logMAR Visual Acuity Chart
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Visual Acuity - High Contrast | -0.08 logMAR | Standard Deviation 0.08 |
| Single Vision Spectacle for Vision Correction | Visual Acuity - High Contrast | -0.08 logMAR | Standard Deviation 0.05 |
Primary
Visual Acuity - Low Contrast
Visual Acuity under low contrast was measured using logMAR Visual Acuity Chart
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Somofilcon A Daily Disposable Contact Lenses | Visual Acuity - Low Contrast | 0.20 logMAR | Standard Deviation 0.1 |
| Single Vision Spectacle for Vision Correction | Visual Acuity - Low Contrast | 0.21 logMAR | Standard Deviation 0.07 |