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

Sponsor
Coopervision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04658797
Collaborator
(none)
30
1
2
5.9
5.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: somofilcon A Daily Disposable Contact Lens
  • Device: Single Vision Spectacle for Vision Correction
  • Other: Personal Facemask
N/A

Detailed Description

This was a two arm parallel-group, randomised study. Subjects wearing single vision spectacles were recruited to participate in the study. Subjects were randomised to either continue to use their spectacles or to be fitted with the study daily disposable (DD) contact lens.

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation on Using Personal Face Masks With Spectacles Versus Contact Lenses
Actual Study Start Date :
Nov 1, 2020
Actual Primary Completion Date :
Apr 15, 2021
Actual Study Completion Date :
Apr 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Single Vision Spectacle for Vision correction

Single Vision Spectacle

Device: Single Vision Spectacle for Vision Correction
Single Vision Spectacle

Other: Personal Facemask
Personal Facemask

Experimental: somofilcon A Daily disposable contact lenses

Daily disposable contact lenses

Device: somofilcon A Daily Disposable Contact Lens
Daily Disposable Contact Lens

Other: Personal Facemask
Personal Facemask

Outcome Measures

Primary Outcome Measures

  1. Visual Acuity - High Contrast [Baseline]

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

  2. Visual Acuity - Low Contrast [Baseline]

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

  3. Visual Acuity - High Contrast [2 weeks]

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

  4. 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)

  5. Subjective Response on Facemask Usability Questionnaire - Breathability [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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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)

  12. 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)

  13. Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes [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)

  14. 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)

  15. Subjective Response on Facemask Usability Questionnaire - Overall Comfort [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)

  16. 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).

  17. Difficulty in Walking When Using Wearing Vision Correction and Facemask [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)

  18. 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)

  19. Difficulty in Driving When Using Wearing Vision Correction and Facemask [2 weeks]

    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)

  20. 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)

  21. Difficulty in Reading When Using Wearing Vision Correction and Facemask [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)

  22. 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)

  23. Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask [2 weeks]

    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)

  24. 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)

  25. Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask [2 weeks]

    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)

  26. 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)

  27. Difficulty in Socializing When Using Wearing Vision Correction and Facemask [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)

  28. 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)

  29. Physical Safety Concerns When Wearing Your Vision Correction and Facemask [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)

  30. 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)

  31. Emotional Impact of Using the Facemask When Wearing Your Vision Correction [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)

  32. 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)

  33. Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eurolens Research Manchester United Kingdom M13 9PL

Sponsors and Collaborators

  • Coopervision, Inc.

Investigators

  • Principal Investigator: Carole Maldonado-Codina, Eurolens Research

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT04658797
Other Study ID Numbers:
  • C20-688 (EX-MKTG-120)
First Posted:
Dec 8, 2020
Last Update Posted:
Oct 20, 2021
Last Verified:
Sep 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Single Vision Spectacle for Vision Correction Somofilcon A Daily Disposable Contact Lenses
Arm/Group Description Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask. Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.
Period Title: Overall Study
STARTED 15 15
COMPLETED 15 15
NOT COMPLETED 0 0

Baseline Characteristics

Arm/Group Title Single Vision Spectacle for Vision Correction Somofilcon A Daily Disposable Contact Lenses Total
Arm/Group Description Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask. Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Total of all reporting groups
Overall Participants 15 15 30
Age (Count of Participants)
<=18 years
0
0%
0
0%
0
0%
Between 18 and 65 years
15
100%
15
100%
30
100%
>=65 years
0
0%
0
0%
0
0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
25.5
(5.3)
27.4
(5.8)
26.5
(5.6)
Sex: Female, Male (Count of Participants)
Female
11
73.3%
11
73.3%
22
73.3%
Male
4
26.7%
4
26.7%
8
26.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]
0
0%
Region of Enrollment (participants) [Number]
United Kingdom
15
100%
15
100%
30
100%

Outcome Measures

1. Primary Outcome
Title Visual Acuity - High Contrast
Description Visual Acuity under high contrast was measured using logMAR Visual Acuity Chart
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Mean (Standard Deviation) [logMAR]
-0.06
(0.07)
-0.07
(0.05)
2. Primary Outcome
Title Visual Acuity - Low Contrast
Description Visual Acuity under low contrast was measured using logMAR Visual Acuity Chart
Time Frame Baseline

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Mean (Standard Deviation) [logMAR]
0.20
(0.10)
0.21
(0.07)
3. Primary Outcome
Title Visual Acuity - High Contrast
Description Visual Acuity under high contrast was measured using logMAR Visual Acuity Chart
Time Frame 2 weeks

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Mean (Standard Deviation) [logMAR]
-0.08
(0.08)
-0.08
(0.05)
4. Primary Outcome
Title Subjective Response on Facemask Usability Questionnaire - Breathability
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Very Satisfactory
1
6.7%
2
13.3%
Satisfactory
4
26.7%
5
33.3%
Average
5
33.3%
6
40%
Unsatisfactory
4
26.7%
2
13.3%
very unsatisfactory
1
6.7%
0
0%
5. Primary Outcome
Title Subjective Response on Facemask Usability Questionnaire - Breathability
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Very Satisfactory
5
33.3%
1
6.7%
Satisfactory
5
33.3%
5
33.3%
Average
5
33.3%
6
40%
Unsatisfactory
0
0%
2
13.3%
very unsatisfactory
0
0%
1
6.7%
6. Primary Outcome
Title Subjective Response on Facemask Usability Questionnaire - Heat
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Very Satisfactory
1
6.7%
0
0%
Satisfactory
2
13.3%
6
40%
Average
3
20%
4
26.7%
Unsatisfactory
8
53.3%
4
26.7%
very unsatisfactory
1
6.7%
1
6.7%
7. Primary Outcome
Title Subjective Response on Facemask Usability Questionnaire -Heat
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Very Satisfactory
3
20%
1
6.7%
Satisfactory
6
40%
2
13.3%
Average
4
26.7%
4
26.7%
Unsatisfactory
2
13.3%
7
46.7%
very unsatisfactory
0
0%
1
6.7%
8. Primary Outcome
Title Subjective Response on Facemask Usability Questionnaire - Tightness
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Very satisfactory
2
13.3%
2
13.3%
Satisfactory
7
46.7%
7
46.7%
Average
4
26.7%
5
33.3%
Unsatisfactory
2
13.3%
1
6.7%
Very unsatisfactory
0
0%
0
0%
9. Primary Outcome
Title Subjective Response on Facemask Usability Questionnaire -Tightness
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Very satisfactory
4
26.7%
0
0%
Satisfactory
7
46.7%
10
66.7%
Average
3
20%
5
33.3%
Unsatisfactory
1
6.7%
0
0%
Very unsatisfactory
0
0%
0
0%
10. Primary Outcome
Title Subjective Response on Facemask Usability Questionnaire - Ease in Talking
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Very satisfactory
2
13.3%
1
6.7%
Satisfactory
3
20%
6
40%
Average
4
26.7%
5
33.3%
Unsatisfactory
5
33.3%
3
20%
Very unsatisfactory
1
6.7%
0
0%
11. Primary Outcome
Title Subjective Response on Facemask Usability Questionnaire -Ease in Talking
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Very satisfactory
3
20%
1
6.7%
Satisfactory
4
26.7%
4
26.7%
Average
4
26.7%
6
40%
Unsatisfactory
4
26.7%
4
26.7%
Very unsatisfactory
0
0%
0
0%
12. Primary Outcome
Title Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Very satisfactory
8
53.3%
3
20%
Satisfactory
2
13.3%
7
46.7%
Average
1
6.7%
2
13.3%
Unsatisfactory
3
20%
3
20%
Very unsatisfactory
1
6.7%
0
0%
13. Primary Outcome
Title Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Very satisfactory
6
40%
4
26.7%
Satisfactory
5
33.3%
6
40%
Average
3
20%
2
13.3%
Unsatisfactory
1
6.7%
3
20%
Very unsatisfactory
0
0%
0
0%
14. Primary Outcome
Title Subjective Response on Facemask Usability Questionnaire - Overall Comfort
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Very satisfactory
0
0%
0
0%
Satisfactory
2
13.3%
5
33.3%
Average
8
53.3%
10
66.7%
Unsatisfactory
4
26.7%
0
0%
Very unsatisfactory
1
6.7%
0
0%
15. Primary Outcome
Title Subjective Response on Facemask Usability Questionnaire - Overall Comfort
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Very satisfactory
3
20%
0
0%
Satisfactory
6
40%
4
26.7%
Average
5
33.3%
7
46.7%
Unsatisfactory
1
6.7%
2
13.3%
Very unsatisfactory
0
0%
2
13.3%
16. Primary Outcome
Title Difficulty in Walking When Using Wearing Vision Correction and Facemask
Description 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

Outcome Measure Data

Analysis Population Description
One subject from somofilcon A Daily disposable contact lenses didn't answer questionnaire.
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 14 15
Very easy
1
6.7%
3
20%
Easy
3
20%
1
6.7%
Neutral
2
13.3%
4
26.7%
Difficult
4
26.7%
6
40%
Very difficult
4
26.7%
1
6.7%
17. Primary Outcome
Title Difficulty in Walking When Using Wearing Vision Correction and Facemask
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Very easy
11
73.3%
3
20%
Easy
4
26.7%
3
20%
Neutral
0
0%
3
20%
Difficult
0
0%
5
33.3%
Very difficult
0
0%
1
6.7%
18. Primary Outcome
Title Difficulty in Driving When Using Wearing Vision Correction and Facemask
Description 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

Outcome Measure Data

Analysis Population Description
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/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 5 9
Very easy
0
0%
0
0%
Easy
0
0%
1
6.7%
Neutral
0
0%
3
20%
Difficult
2
13.3%
2
13.3%
Very difficult
3
20%
3
20%
19. Primary Outcome
Title Difficulty in Driving When Using Wearing Vision Correction and Facemask
Description 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

Outcome Measure Data

Analysis Population Description
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/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 4 8
Very Easy
3
20%
0
0%
Easy
1
6.7%
2
13.3%
Neutral
0
0%
2
13.3%
Difficult
0
0%
1
6.7%
Very Difficult
0
0%
3
20%
20. Primary Outcome
Title Difficulty in Reading When Using Wearing Vision Correction and Facemask
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Very easy
1
6.7%
2
13.3%
Easy
1
6.7%
2
13.3%
Neutral
3
20%
6
40%
Difficult
7
46.7%
4
26.7%
Very difficult
3
20%
1
6.7%
21. Primary Outcome
Title Difficulty in Reading When Using Wearing Vision Correction and Facemask
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Very easy
9
60%
2
13.3%
Easy
3
20%
4
26.7%
Neutral
3
20%
3
20%
Difficult
0
0%
4
26.7%
Very difficult
0
0%
2
13.3%
22. Primary Outcome
Title Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask
Description 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

Outcome Measure Data

Analysis Population Description
3 subjects from somofilcon A Daily disposable contact lenses didn't answer the question.
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 12 15
Very easy
1
6.7%
1
6.7%
Easy
0
0%
3
20%
Neutral
1
6.7%
4
26.7%
Difficult
8
53.3%
6
40%
Very difficult
2
13.3%
1
6.7%
23. Primary Outcome
Title Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask
Description 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

Outcome Measure Data

Analysis Population Description
1 subject from somofilcon A Daily disposable contact lenses didn't answer the question.
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 14 15
Very easy
7
46.7%
3
20%
Easy
3
20%
3
20%
Neutral
3
20%
3
20%
Difficult
1
6.7%
4
26.7%
Very difficult
0
0%
2
13.3%
24. Primary Outcome
Title Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask
Description 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

Outcome Measure Data

Analysis Population Description
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/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 8 11
Very easy
0
0%
0
0%
Easy
0
0%
0
0%
Neutral
0
0%
0
0%
Difficult
2
13.3%
7
46.7%
Very difficult
6
40%
4
26.7%
25. Primary Outcome
Title Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask
Description 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

Outcome Measure Data

Analysis Population Description
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/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 13 12
Very Easy
6
40%
0
0%
Easy
4
26.7%
0
0%
Neutral
3
20%
0
0%
Difficult
0
0%
9
60%
Very Difficult
0
0%
3
20%
26. Primary Outcome
Title Difficulty in Socializing When Using Wearing Vision Correction and Facemask
Description 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

Outcome Measure Data

Analysis Population Description
1 subject from somofilcon A Daily disposable contact lenses didn't answer the question.
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 14 15
Very Easy
0
0%
2
13.3%
Easy
2
13.3%
2
13.3%
Difficult
3
20%
4
26.7%
Neutral
4
26.7%
5
33.3%
Very Difficult
5
33.3%
2
13.3%
27. Primary Outcome
Title Difficulty in Socializing When Using Wearing Vision Correction and Facemask
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Very easy
6
40%
2
13.3%
Easy
5
33.3%
2
13.3%
Difficult
1
6.7%
4
26.7%
Neutral
3
20%
5
33.3%
Very difficult
0
0%
2
13.3%
28. Primary Outcome
Title Physical Safety Concerns When Wearing Your Vision Correction and Facemask
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Not at all concerned
6
40%
9
60%
Slightly concerned
1
6.7%
3
20%
Somewhat concerned
3
20%
1
6.7%
Moderately concerned
5
33.3%
2
13.3%
Extremely concerned
0
0%
0
0%
29. Primary Outcome
Title Physical Safety Concerns When Wearing Your Vision Correction and Facemask
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Not at all concerned
12
80%
9
60%
Slightly concerned
3
20%
3
20%
Somewhat concerned
0
0%
1
6.7%
Moderately concerned
0
0%
1
6.7%
Extremely concerned
0
0%
1
6.7%
30. Primary Outcome
Title Emotional Impact of Using the Facemask When Wearing Your Vision Correction
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Insignificant
5
33.3%
7
46.7%
Minor
6
40%
6
40%
Moderate
3
20%
2
13.3%
Major
1
6.7%
0
0%
Severe
0
0%
0
0%
31. Primary Outcome
Title Emotional Impact of Using the Facemask When Wearing Your Vision Correction
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Insignificant
8
53.3%
6
40%
Minor
6
40%
6
40%
Moderate
1
6.7%
3
20%
Major
0
0%
0
0%
Severe
0
0%
0
0%
32. Primary Outcome
Title Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Insignificant
5
33.3%
2
13.3%
Minor
3
20%
6
40%
Moderate
4
26.7%
3
20%
Major
3
20%
3
20%
Severe
0
0%
1
6.7%
33. Primary Outcome
Title Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction
Description 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

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Somofilcon A Daily Disposable Contact Lenses Single Vision Spectacle for Vision Correction
Arm/Group Description Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask. Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask.
Measure Participants 15 15
Insignificant
7
46.7%
3
20%
Minor
6
40%
8
53.3%
Moderate
2
13.3%
3
20%
Major
0
0%
0
0%
Severe
0
0%
1
6.7%

Adverse Events

Time Frame Subjects were randomized to wear single vision spectacle and somofilcon A daily disposable contact lenses along with personalized face masks - from dispense to 2 weeks visit - a total of two weeks.
Adverse Event Reporting Description
Arm/Group Title Single Vision Spectacle for Vision Correction Somofilcon A Daily Disposable Contact Lenses
Arm/Group Description Subjects were randomized to wear Single Vision Spectacle for Vision Correction: Single Vision Spectacle along with personal Facemask. Subjects were randomized to wear somofilcon A Daily Disposable Contact Lens along with personal Facemask.
All Cause Mortality
Single Vision Spectacle for Vision Correction Somofilcon A Daily Disposable Contact Lenses
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/15 (0%) 0/15 (0%)
Serious Adverse Events
Single Vision Spectacle for Vision Correction Somofilcon A Daily Disposable Contact Lenses
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/15 (0%) 0/15 (0%)
Other (Not Including Serious) Adverse Events
Single Vision Spectacle for Vision Correction Somofilcon A Daily Disposable Contact Lenses
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/15 (0%) 0/15 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Jose Vega, OD, MSc, FAAO
Organization CooperVision, Inc
Phone 9256213761
Email JVega2@coopervision.com
Responsible Party:
Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT04658797
Other Study ID Numbers:
  • C20-688 (EX-MKTG-120)
First Posted:
Dec 8, 2020
Last Update Posted:
Oct 20, 2021
Last Verified:
Sep 1, 2021