Trial Outcomes & Findings for Clinical Evaluation on Using Personal Face Masks With Spectacles Versus Contact Lenses (NCT NCT04658797)

NCT ID: NCT04658797

Last Updated: 2021-10-20

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2021-10-20

Participant Flow

Participant milestones

Measure	Single Vision Spectacle for Vision Correction Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.	Somofilcon A Daily Disposable Contact Lenses Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=15 Participants	15 Participants n=15 Participants	30 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Age, Continuous	25.5 years STANDARD_DEVIATION 5.3 • n=15 Participants	27.4 years STANDARD_DEVIATION 5.8 • n=15 Participants	26.5 years STANDARD_DEVIATION 5.6 • n=30 Participants
Sex: Female, Male Female	11 Participants n=15 Participants	11 Participants n=15 Participants	22 Participants n=30 Participants
Sex: Female, Male Male	4 Participants n=15 Participants	4 Participants n=15 Participants	8 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	15 participants n=15 Participants	15 participants n=15 Participants	30 participants n=30 Participants

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Visual Acuity - High Contrast	-0.06 logMAR Standard Deviation 0.07	-0.07 logMAR Standard Deviation 0.05

PRIMARY outcome

Timeframe: Baseline

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

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Visual Acuity - Low Contrast	0.20 logMAR Standard Deviation 0.10	0.21 logMAR Standard Deviation 0.07

PRIMARY outcome

Timeframe: 2 weeks

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

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Visual Acuity - High Contrast	-0.08 logMAR Standard Deviation 0.08	-0.08 logMAR Standard Deviation 0.05

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Subjective Response on Facemask Usability Questionnaire - Breathability Satisfactory	4 Participants	5 Participants
Subjective Response on Facemask Usability Questionnaire - Breathability Unsatisfactory	4 Participants	2 Participants
Subjective Response on Facemask Usability Questionnaire - Breathability very unsatisfactory	1 Participants	0 Participants
Subjective Response on Facemask Usability Questionnaire - Breathability Very Satisfactory	1 Participants	2 Participants
Subjective Response on Facemask Usability Questionnaire - Breathability Average	5 Participants	6 Participants

PRIMARY outcome

Timeframe: 2 weeks

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

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Subjective Response on Facemask Usability Questionnaire - Breathability Average	5 Participants	6 Participants
Subjective Response on Facemask Usability Questionnaire - Breathability Unsatisfactory	0 Participants	2 Participants
Subjective Response on Facemask Usability Questionnaire - Breathability very unsatisfactory	0 Participants	1 Participants
Subjective Response on Facemask Usability Questionnaire - Breathability Very Satisfactory	5 Participants	1 Participants
Subjective Response on Facemask Usability Questionnaire - Breathability Satisfactory	5 Participants	5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Subjective Response on Facemask Usability Questionnaire - Heat Satisfactory	2 Participants	6 Participants
Subjective Response on Facemask Usability Questionnaire - Heat Average	3 Participants	4 Participants
Subjective Response on Facemask Usability Questionnaire - Heat Unsatisfactory	8 Participants	4 Participants
Subjective Response on Facemask Usability Questionnaire - Heat Very Satisfactory	1 Participants	0 Participants
Subjective Response on Facemask Usability Questionnaire - Heat very unsatisfactory	1 Participants	1 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Subjective Response on Facemask Usability Questionnaire -Heat Very Satisfactory	3 Participants	1 Participants
Subjective Response on Facemask Usability Questionnaire -Heat Satisfactory	6 Participants	2 Participants
Subjective Response on Facemask Usability Questionnaire -Heat Average	4 Participants	4 Participants
Subjective Response on Facemask Usability Questionnaire -Heat Unsatisfactory	2 Participants	7 Participants
Subjective Response on Facemask Usability Questionnaire -Heat very unsatisfactory	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Subjective Response on Facemask Usability Questionnaire - Tightness Very satisfactory	2 Participants	2 Participants
Subjective Response on Facemask Usability Questionnaire - Tightness Satisfactory	7 Participants	7 Participants
Subjective Response on Facemask Usability Questionnaire - Tightness Average	4 Participants	5 Participants
Subjective Response on Facemask Usability Questionnaire - Tightness Unsatisfactory	2 Participants	1 Participants
Subjective Response on Facemask Usability Questionnaire - Tightness Very unsatisfactory	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Subjective Response on Facemask Usability Questionnaire -Tightness Very satisfactory	4 Participants	0 Participants
Subjective Response on Facemask Usability Questionnaire -Tightness Satisfactory	7 Participants	10 Participants
Subjective Response on Facemask Usability Questionnaire -Tightness Average	3 Participants	5 Participants
Subjective Response on Facemask Usability Questionnaire -Tightness Unsatisfactory	1 Participants	0 Participants
Subjective Response on Facemask Usability Questionnaire -Tightness Very unsatisfactory	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Subjective Response on Facemask Usability Questionnaire - Ease in Talking Very satisfactory	2 Participants	1 Participants
Subjective Response on Facemask Usability Questionnaire - Ease in Talking Satisfactory	3 Participants	6 Participants
Subjective Response on Facemask Usability Questionnaire - Ease in Talking Average	4 Participants	5 Participants
Subjective Response on Facemask Usability Questionnaire - Ease in Talking Unsatisfactory	5 Participants	3 Participants
Subjective Response on Facemask Usability Questionnaire - Ease in Talking Very unsatisfactory	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Subjective Response on Facemask Usability Questionnaire -Ease in Talking Satisfactory	4 Participants	4 Participants
Subjective Response on Facemask Usability Questionnaire -Ease in Talking Average	4 Participants	6 Participants
Subjective Response on Facemask Usability Questionnaire -Ease in Talking Unsatisfactory	4 Participants	4 Participants
Subjective Response on Facemask Usability Questionnaire -Ease in Talking Very satisfactory	3 Participants	1 Participants
Subjective Response on Facemask Usability Questionnaire -Ease in Talking Very unsatisfactory	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes Unsatisfactory	3 Participants	3 Participants
Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes Very unsatisfactory	1 Participants	0 Participants
Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes Very satisfactory	8 Participants	3 Participants
Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes Satisfactory	2 Participants	7 Participants
Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes Average	1 Participants	2 Participants

PRIMARY outcome

Timeframe: 2 Weeks

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

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes Very satisfactory	6 Participants	4 Participants
Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes Very unsatisfactory	0 Participants	0 Participants
Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes Satisfactory	5 Participants	6 Participants
Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes Average	3 Participants	2 Participants
Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes Unsatisfactory	1 Participants	3 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Subjective Response on Facemask Usability Questionnaire - Overall Comfort Very satisfactory	0 Participants	0 Participants
Subjective Response on Facemask Usability Questionnaire - Overall Comfort Satisfactory	2 Participants	5 Participants
Subjective Response on Facemask Usability Questionnaire - Overall Comfort Average	8 Participants	10 Participants
Subjective Response on Facemask Usability Questionnaire - Overall Comfort Unsatisfactory	4 Participants	0 Participants
Subjective Response on Facemask Usability Questionnaire - Overall Comfort Very unsatisfactory	1 Participants	0 Participants

PRIMARY outcome

Timeframe: 2 Weeks

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

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Subjective Response on Facemask Usability Questionnaire - Overall Comfort Satisfactory	6 Participants	4 Participants
Subjective Response on Facemask Usability Questionnaire - Overall Comfort Average	5 Participants	7 Participants
Subjective Response on Facemask Usability Questionnaire - Overall Comfort Very satisfactory	3 Participants	0 Participants
Subjective Response on Facemask Usability Questionnaire - Overall Comfort Unsatisfactory	1 Participants	2 Participants
Subjective Response on Facemask Usability Questionnaire - Overall Comfort Very unsatisfactory	0 Participants	2 Participants

PRIMARY outcome

Timeframe: Baseline

Population: One subject from somofilcon A Daily disposable contact lenses didn't answer questionnaire.

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).

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=14 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Difficulty in Walking When Using Wearing Vision Correction and Facemask Difficult	4 Participants	6 Participants
Difficulty in Walking When Using Wearing Vision Correction and Facemask Very easy	1 Participants	3 Participants
Difficulty in Walking When Using Wearing Vision Correction and Facemask Easy	3 Participants	1 Participants
Difficulty in Walking When Using Wearing Vision Correction and Facemask Neutral	2 Participants	4 Participants
Difficulty in Walking When Using Wearing Vision Correction and Facemask Very difficult	4 Participants	1 Participants

PRIMARY outcome

Timeframe: 2 Weeks

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

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Difficulty in Walking When Using Wearing Vision Correction and Facemask Very easy	11 Participants	3 Participants
Difficulty in Walking When Using Wearing Vision Correction and Facemask Easy	4 Participants	3 Participants
Difficulty in Walking When Using Wearing Vision Correction and Facemask Difficult	0 Participants	5 Participants
Difficulty in Walking When Using Wearing Vision Correction and Facemask Very difficult	0 Participants	1 Participants
Difficulty in Walking When Using Wearing Vision Correction and Facemask Neutral	0 Participants	3 Participants

PRIMARY outcome

Timeframe: 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.

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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=5 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=9 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Difficulty in Driving When Using Wearing Vision Correction and Facemask Very easy	0 Participants	0 Participants
Difficulty in Driving When Using Wearing Vision Correction and Facemask Difficult	2 Participants	2 Participants
Difficulty in Driving When Using Wearing Vision Correction and Facemask Very difficult	3 Participants	3 Participants
Difficulty in Driving When Using Wearing Vision Correction and Facemask Easy	0 Participants	1 Participants
Difficulty in Driving When Using Wearing Vision Correction and Facemask Neutral	0 Participants	3 Participants

PRIMARY outcome

Timeframe: 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.

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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=4 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=8 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Difficulty in Driving When Using Wearing Vision Correction and Facemask Easy	1 Participants	2 Participants
Difficulty in Driving When Using Wearing Vision Correction and Facemask Neutral	0 Participants	2 Participants
Difficulty in Driving When Using Wearing Vision Correction and Facemask Difficult	0 Participants	1 Participants
Difficulty in Driving When Using Wearing Vision Correction and Facemask Very Easy	3 Participants	0 Participants
Difficulty in Driving When Using Wearing Vision Correction and Facemask Very Difficult	0 Participants	3 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Difficulty in Reading When Using Wearing Vision Correction and Facemask Easy	1 Participants	2 Participants
Difficulty in Reading When Using Wearing Vision Correction and Facemask Neutral	3 Participants	6 Participants
Difficulty in Reading When Using Wearing Vision Correction and Facemask Difficult	7 Participants	4 Participants
Difficulty in Reading When Using Wearing Vision Correction and Facemask Very difficult	3 Participants	1 Participants
Difficulty in Reading When Using Wearing Vision Correction and Facemask Very easy	1 Participants	2 Participants

PRIMARY outcome

Timeframe: 2 weeks

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

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Difficulty in Reading When Using Wearing Vision Correction and Facemask Very easy	9 Participants	2 Participants
Difficulty in Reading When Using Wearing Vision Correction and Facemask Easy	3 Participants	4 Participants
Difficulty in Reading When Using Wearing Vision Correction and Facemask Neutral	3 Participants	3 Participants
Difficulty in Reading When Using Wearing Vision Correction and Facemask Difficult	0 Participants	4 Participants
Difficulty in Reading When Using Wearing Vision Correction and Facemask Very difficult	0 Participants	2 Participants

PRIMARY outcome

Timeframe: Baseline

Population: 3 subjects from somofilcon A Daily disposable contact lenses didn't answer the question.

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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=12 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask Very easy	1 Participants	1 Participants
Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask Easy	0 Participants	3 Participants
Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask Neutral	1 Participants	4 Participants
Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask Difficult	8 Participants	6 Participants
Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask Very difficult	2 Participants	1 Participants

PRIMARY outcome

Timeframe: 2 weeks

Population: 1 subject from somofilcon A Daily disposable contact lenses didn't answer the question.

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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=14 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask Easy	3 Participants	3 Participants
Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask Neutral	3 Participants	3 Participants
Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask Very easy	7 Participants	3 Participants
Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask Difficult	1 Participants	4 Participants
Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask Very difficult	0 Participants	2 Participants

PRIMARY outcome

Timeframe: 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.

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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=8 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=11 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask Easy	0 Participants	0 Participants
Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask Very easy	0 Participants	0 Participants
Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask Neutral	0 Participants	0 Participants
Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask Difficult	2 Participants	7 Participants
Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask Very difficult	6 Participants	4 Participants

PRIMARY outcome

Timeframe: 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.

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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=13 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=12 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask Very Easy	6 Participants	0 Participants
Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask Neutral	3 Participants	0 Participants
Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask Easy	4 Participants	0 Participants
Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask Difficult	0 Participants	9 Participants
Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask Very Difficult	0 Participants	3 Participants

PRIMARY outcome

Timeframe: Baseline

Population: 1 subject from somofilcon A Daily disposable contact lenses didn't answer the question.

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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=14 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Difficulty in Socializing When Using Wearing Vision Correction and Facemask Neutral	4 Participants	5 Participants
Difficulty in Socializing When Using Wearing Vision Correction and Facemask Very Difficult	5 Participants	2 Participants
Difficulty in Socializing When Using Wearing Vision Correction and Facemask Very Easy	0 Participants	2 Participants
Difficulty in Socializing When Using Wearing Vision Correction and Facemask Easy	2 Participants	2 Participants
Difficulty in Socializing When Using Wearing Vision Correction and Facemask Difficult	3 Participants	4 Participants

PRIMARY outcome

Timeframe: 2 weeks

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

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Difficulty in Socializing When Using Wearing Vision Correction and Facemask Very easy	6 Participants	2 Participants
Difficulty in Socializing When Using Wearing Vision Correction and Facemask Easy	5 Participants	2 Participants
Difficulty in Socializing When Using Wearing Vision Correction and Facemask Very difficult	0 Participants	2 Participants
Difficulty in Socializing When Using Wearing Vision Correction and Facemask Difficult	1 Participants	4 Participants
Difficulty in Socializing When Using Wearing Vision Correction and Facemask Neutral	3 Participants	5 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Physical Safety Concerns When Wearing Your Vision Correction and Facemask Not at all concerned	6 Participants	9 Participants
Physical Safety Concerns When Wearing Your Vision Correction and Facemask Slightly concerned	1 Participants	3 Participants
Physical Safety Concerns When Wearing Your Vision Correction and Facemask Moderately concerned	5 Participants	2 Participants
Physical Safety Concerns When Wearing Your Vision Correction and Facemask Extremely concerned	0 Participants	0 Participants
Physical Safety Concerns When Wearing Your Vision Correction and Facemask Somewhat concerned	3 Participants	1 Participants

PRIMARY outcome

Timeframe: 2 weeks

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

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Physical Safety Concerns When Wearing Your Vision Correction and Facemask Not at all concerned	12 Participants	9 Participants
Physical Safety Concerns When Wearing Your Vision Correction and Facemask Somewhat concerned	0 Participants	1 Participants
Physical Safety Concerns When Wearing Your Vision Correction and Facemask Moderately concerned	0 Participants	1 Participants
Physical Safety Concerns When Wearing Your Vision Correction and Facemask Extremely concerned	0 Participants	1 Participants
Physical Safety Concerns When Wearing Your Vision Correction and Facemask Slightly concerned	3 Participants	3 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Emotional Impact of Using the Facemask When Wearing Your Vision Correction Insignificant	5 Participants	7 Participants
Emotional Impact of Using the Facemask When Wearing Your Vision Correction Minor	6 Participants	6 Participants
Emotional Impact of Using the Facemask When Wearing Your Vision Correction Moderate	3 Participants	2 Participants
Emotional Impact of Using the Facemask When Wearing Your Vision Correction Major	1 Participants	0 Participants
Emotional Impact of Using the Facemask When Wearing Your Vision Correction Severe	0 Participants	0 Participants

PRIMARY outcome

Timeframe: 2 weeks

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

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Emotional Impact of Using the Facemask When Wearing Your Vision Correction Major	0 Participants	0 Participants
Emotional Impact of Using the Facemask When Wearing Your Vision Correction Severe	0 Participants	0 Participants
Emotional Impact of Using the Facemask When Wearing Your Vision Correction Insignificant	8 Participants	6 Participants
Emotional Impact of Using the Facemask When Wearing Your Vision Correction Minor	6 Participants	6 Participants
Emotional Impact of Using the Facemask When Wearing Your Vision Correction Moderate	1 Participants	3 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction Insignificant	5 Participants	2 Participants
Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction Minor	3 Participants	6 Participants
Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction Moderate	4 Participants	3 Participants
Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction Major	3 Participants	3 Participants
Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction Severe	0 Participants	1 Participants

PRIMARY outcome

Timeframe: 2 weeks

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

Outcome measures

Measure	Somofilcon A Daily Disposable Contact Lenses n=15 Participants Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.	Single Vision Spectacle for Vision Correction n=15 Participants Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction Major	0 Participants	0 Participants
Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction Severe	0 Participants	1 Participants
Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction Insignificant	7 Participants	3 Participants
Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction Minor	6 Participants	8 Participants
Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction Moderate	2 Participants	3 Participants

Adverse Events

Single Vision Spectacle for Vision Correction

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Somofilcon A Daily Disposable Contact Lenses

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jose Vega, OD, MSc, FAAO

CooperVision, Inc

Phone: 9256213761

Email: JVega2@coopervision.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place