MyopiaNCT04658797
Clinical Evaluation on Using Personal Face Masks With Spectacles Versus Contact Lenses
A study testing somofilcon A Daily Disposable Contact Lens, Single Vision Spectacle for Vision Correction and Personal Facemask in people with Myopia, run by CooperVision, Inc. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Myopia
- What is being tested?
- somofilcon A Daily Disposable Contact Lens, Single Vision Spectacle for Vision Correction and Personal Facemask
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2020to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- They are aged between 18 and 40 years.
- They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They are a 'neophyte' (i.e. someone who has not worn contact lenses previously, with the exception for the purposes of a trial fitting).
- They have a contact lens spherical prescription between +8.00D and -10.00D (inclusive) based on the ocular refraction.
- They have a cylindrical correction of -0.75DC or less in each eye based on the ocular refraction.
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- They own and habitually wear single vision spectacles.
- They are willing to be fitted with contact lenses and understand they may be randomised to either group.
- They are willing to wear the contact lenses (if relevant) or spectacles for at least 8 hours per day, 5 days per week.
- They are able to wear the supplied surgical masks for the majority of time that they need to wear PFM and will wear the PFM for at least one hour a day for at least four days per week.
- They can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses (if relevant) or spectacles.
- They agree to not participate in other clinical research while enrolled on this study.
Who cannot join
- They have an ocular disorder which would normally contra-indicate contact lens
- wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment.
- They have had cataract surgery.
- They have had corneal refractive surgery.
Show all 13Show fewer
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- They are pregnant or breastfeeding.
- They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
- They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
- They require significant ocular/face personal protective equipment beyond a personal face mask.
- They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
- They have spectacles which are not within ±0.50D of their refractive error.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Myopia
- Being tested
- somofilcon A Daily Disposable Contact Lens, Single Vision Spectacle for Vision Correction, Personal Facemask
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somofilcon A Daily Disposable Contact LensDevice
Daily Disposable Contact Lens
Single Vision Spectacle for Vision CorrectionDevice
Single Vision Spectacle
Personal FacemaskOther
Personal Facemask
| Study group | Role | What they receive |
|---|---|---|
| Single Vision Spectacle for Vision correction | Active comparator | Single Vision Spectacle Receives: Device: Single Vision Spectacle for Vision Correction; Other: Personal Facemask |
| somofilcon A Daily disposable contact lenses | Experimental | Daily disposable contact lenses Receives: Device: somofilcon A Daily Disposable Contact Lens; Other: Personal Facemask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity - High Contrast
Visual Acuity under high contrast was measured using logMAR Visual Acuity Chart
Measured: Baseline
Visual Acuity - Low Contrast
Visual Acuity under low contrast was measured using logMAR Visual Acuity Chart
Measured: Baseline
Visual Acuity - High Contrast
Visual Acuity under high contrast was measured using logMAR Visual Acuity Chart
Measured: 2 weeks
Subjective Response on Facemask Usability Questionnaire - Breathability
Subjective response on facemask usability questionnaire - Breathability assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)
Measured: Baseline
Subjective Response on Facemask Usability Questionnaire - Breathability
Subjective response on facemask usability questionnaire - Breathability assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)
Measured: 2 weeks
Subjective Response on Facemask Usability Questionnaire - Heat
Subjective response on facemask usability questionnaire - Heat assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)
Measured: Baseline
Subjective Response on Facemask Usability Questionnaire -Heat
Subjective response on facemask usability questionnaire - Heat assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)
Measured: 2 weeks
Subjective Response on Facemask Usability Questionnaire - Tightness
Subjective response on facemask usability questionnaire - Tightness assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)
Measured: Baseline
Subjective Response on Facemask Usability Questionnaire -Tightness
Subjective response on facemask usability questionnaire - Tightness assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)
Measured: 2 weeks
Subjective Response on Facemask Usability Questionnaire - Ease in Talking
Subjective response on facemask usability questionnaire - Ease in Talking assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)
Measured: Baseline
Subjective Response on Facemask Usability Questionnaire -Ease in Talking
Subjective response on facemask usability questionnaire - Ease in Talking assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)
Measured: 2 weeks
Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes
Subjective response on facemask usability questionnaire - Comfort on ear lobes assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)
Measured: Baseline
Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes
Subjective response on facemask usability questionnaire - Comfort on ear lobes assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)
Measured: 2 Weeks
Subjective Response on Facemask Usability Questionnaire - Overall Comfort
Subjective response on facemask usability questionnaire - Overall Comfort assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)
Measured: Baseline
Subjective Response on Facemask Usability Questionnaire - Overall Comfort
Subjective response on facemask usability questionnaire - Overall Comfort assessed on a 5 point scale (1- very unsatisfactory, 2- Unsatisfactory, 3- Average, 4- Satisfactory, 5- Very Satisfactory)
Measured: 2 Weeks
Difficulty in Walking When Using Wearing Vision Correction and Facemask
Difficulty in walking when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy).
Measured: Baseline
Difficulty in Walking When Using Wearing Vision Correction and Facemask
Difficulty in walking when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)
Measured: 2 Weeks
Difficulty in Driving When Using Wearing Vision Correction and Facemask
Difficulty in driving when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)
Measured: Baseline
Difficulty in Driving When Using Wearing Vision Correction and Facemask
Difficulty in driving when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)
Measured: 2 weeks
Difficulty in Reading When Using Wearing Vision Correction and Facemask
Difficulty in reading when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)
Measured: Baseline
Difficulty in Reading When Using Wearing Vision Correction and Facemask
Difficulty in reading when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)
Measured: 2 weeks
Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask
Difficulty in working with a computer when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)
Measured: Baseline
Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask
Difficulty in working with a computer when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)
Measured: 2 weeks
Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask
Difficulty in exercising (physical activities)when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)
Measured: Baseline
Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask
Difficulty in exercising (physical activities)when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)
Measured: 2 weeks
Difficulty in Socializing When Using Wearing Vision Correction and Facemask
Difficulty in socializing when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)
Measured: Baseline
Difficulty in Socializing When Using Wearing Vision Correction and Facemask
Difficulty in socializing when using wearing vision correction and facemask assessed on a scale of 1-5 (1- very difficult, 2- difficult, 3- Neutral, 4, Easy, 5- Very Easy)
Measured: 2 weeks
Physical Safety Concerns When Wearing Your Vision Correction and Facemask
Physical safety concerns when wearing your vision correction and facemask assessed on a scale of 1-5 (1- Extremely concerned, 2 - Moderately concerned, 3- Somewhat concerned, 4 -Slightly concerned, 5- Not at all concerned)
Measured: Baseline
Physical Safety Concerns When Wearing Your Vision Correction and Facemask
Physical safety concerns when wearing your vision correction and facemask assessed on a scale of 1-5 (1- Extremely concerned, 2 - Moderately concerned, 3- Somewhat concerned, 4 -Slightly concerned, 5- Not at all concerned)
Measured: 2 weeks
Emotional Impact of Using the Facemask When Wearing Your Vision Correction
Emotional impact of using the facemask when wearing your vision correction assessed on a scale of 1-5 (1- Severe, 2- Major, 3- Moderate, 4- Minor, 5- Insignificant)
Measured: Baseline
Emotional Impact of Using the Facemask When Wearing Your Vision Correction
Emotional impact of using the facemask when wearing your vision correction assessed on a scale of 1-5 (1- Severe, 2- Major, 3- Moderate, 4- Minor, 5- Insignificant)
Measured: 2 weeks
Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction
Impact of using the facemask on your personal appearance when wearing your vision correction assessed on a scale of 1-5 (1- Severe, 2- Major, 3- Moderate, 4- Minor, 5- Insignificant)
Measured: Baseline
Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction
Impact of using the facemask on your personal appearance when wearing your vision correction assessed on a scale of 1-5 (1- Severe, 2- Major, 3- Moderate, 4- Minor, 5- Insignificant)
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2020 (estimated)
- Study start1 Nov 2020
- Primary completion15 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- CooperVision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carole Maldonado-Codina, Principal investigator, Eurolens Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04658797
- Sponsor's protocol ID
- C20-688 (EX-MKTG-120)
- Status last verified
- Sep 2021
- First submitted
- 1 Dec 2020
- Last updated
- 20 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation on Using Personal Face Masks With Spectacles Versus Contact Lenses
- ClinicalTrials.gov ID
- NCT04658797
- Acronym / sponsor ID
- C20-688 (EX-MKTG-120)
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- CooperVision, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 8 Dec 2020 (estimated)
- Results
- Posted 20 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Vision Spectacle for Vision correction | Active comparator | Device: Single Vision Spectacle for Vision Correction, Other: Personal FacemaskSingle Vision Spectacle |
| somofilcon A Daily disposable contact lenses | Experimental | Device: somofilcon A Daily Disposable Contact Lens, Other: Personal FacemaskDaily disposable contact lenses |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- They are aged between 18 and 40 years.
- They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They are a 'neophyte' (i.e. someone who has not worn contact lenses previously, with the exception for the purposes of a trial fitting).
- They have a contact lens spherical prescription between +8.00D and -10.00D (inclusive) based on the ocular refraction.
Key exclusion criteria (13 listed)
- They have an ocular disorder which would normally contra-indicate contact lens
- wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment.
- They have had cataract surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| somofilcon A Daily Disposable Contact LensDaily Disposable Contact Lens | Device | somofilcon A Daily disposable contact lenses |
| Single Vision Spectacle for Vision CorrectionSingle Vision Spectacle | Device | Single Vision Spectacle for Vision correction |
| Personal FacemaskPersonal Facemask | Other | Single Vision Spectacle for Vision correction, somofilcon A Daily disposable contact lenses |
Primary outcome
Visual Acuity - High Contrast
Time frame: Baseline
Visual Acuity under high contrast was measured using logMAR Visual Acuity Chart
Visual Acuity - Low Contrast
Time frame: Baseline
Visual Acuity under low contrast was measured using logMAR Visual Acuity Chart
Visual Acuity - High Contrast
Time frame: 2 weeks
Visual Acuity under high contrast was measured using logMAR Visual Acuity Chart
Subjective Response on Facemask Usability Questionnaire - Breathability
Time frame: 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 - Breathability
Time frame: 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)
Subjective Response on Facemask Usability Questionnaire - Heat
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 - Comfort on Ear Lobes
Time frame: 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)
Subjective Response on Facemask Usability Questionnaire - Overall Comfort
Time frame: 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)
Subjective Response on Facemask Usability Questionnaire - Overall Comfort
Time frame: 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)
Difficulty in Walking When Using Wearing Vision Correction and Facemask
Time frame: 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 Walking When Using Wearing Vision Correction and Facemask
Time frame: 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)
Difficulty in Driving When Using Wearing Vision Correction and Facemask
Time frame: 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 Driving When Using Wearing Vision Correction and Facemask
Time frame: 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)
Difficulty in Reading When Using Wearing Vision Correction and Facemask
Time frame: 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 Reading When Using Wearing Vision Correction and Facemask
Time frame: 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)
Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask
Time frame: 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 Working With a Computer When Using Wearing Vision Correction and Facemask
Time frame: 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)
Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask
Time frame: 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 Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask
Time frame: 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)
Difficulty in Socializing When Using Wearing Vision Correction and Facemask
Time frame: 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)
Difficulty in Socializing When Using Wearing Vision Correction and Facemask
Time frame: 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)
Physical Safety Concerns When Wearing Your Vision Correction and Facemask
Time frame: 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)
Physical Safety Concerns When Wearing Your Vision Correction and Facemask
Time frame: 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)
Emotional Impact of Using the Facemask When Wearing Your Vision Correction
Time frame: 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)
Emotional Impact of Using the Facemask When Wearing Your Vision Correction
Time frame: 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)
Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction
Time frame: 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)
Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction
Time frame: 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)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carole Maldonado-Codina principal investigator
Eurolens Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing somofilcon A Daily Disposable Contact Lens, Single Vision Spectacle for Vision Correction and Personal Facemask in people with Myopia, run by CooperVision, Inc. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity - High Contrast (time frame: Baseline). The study lists 33 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.