Clinical trial NCT04658797: Clinical Evaluation on Using Personal Face Masks With Spectacles Versus Contact Lenses
Official title: Clinical Evaluation on Using Personal Face Masks With Spectacles Versus Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2020-12-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to explore satisfaction with vision correction and ease of use of PFM (Personal Face Masks) in a group of spectacle wearers who were randomised to continue wearing spectacles or be fitted with daily disposable contact lenses.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Visual Acuity - High Contrast
timeFrame: Baseline
measure: Visual Acuity - Low Contrast
timeFrame: Baseline
measure: Visual Acuity - High Contrast
timeFrame: 2 weeks
measure: Subjective Response on Facemask Usability Questionnaire - Breathability
timeFrame: Baseline
measure: Subjective Response on Facemask Usability Questionnaire - Breathability
timeFrame: 2 weeks
measure: Subjective Response on Facemask Usability Questionnaire - Heat
timeFrame: Baseline
measure: Subjective Response on Facemask Usability Questionnaire -Heat
timeFrame: 2 weeks
measure: Subjective Response on Facemask Usability Questionnaire - Tightness
timeFrame: Baseline
measure: Subjective Response on Facemask Usability Questionnaire -Tightness
timeFrame: 2 weeks
measure: Subjective Response on Facemask Usability Questionnaire - Ease in Talking
timeFrame: Baseline
measure: Subjective Response on Facemask Usability Questionnaire -Ease in Talking
timeFrame: 2 weeks
measure: Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes
timeFrame: Baseline
measure: Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes
timeFrame: 2 Weeks
measure: Subjective Response on Facemask Usability Questionnaire - Overall Comfort
timeFrame: Baseline
measure: Subjective Response on Facemask Usability Questionnaire - Overall Comfort
timeFrame: 2 Weeks
measure: Difficulty in Walking When Using Wearing Vision Correction and Facemask
timeFrame: Baseline
measure: Difficulty in Walking When Using Wearing Vision Correction and Facemask
timeFrame: 2 Weeks
measure: Difficulty in Driving When Using Wearing Vision Correction and Facemask
timeFrame: Baseline
measure: Difficulty in Driving When Using Wearing Vision Correction and Facemask
timeFrame: 2 weeks
measure: Difficulty in Reading When Using Wearing Vision Correction and Facemask
timeFrame: Baseline
measure: Difficulty in Reading When Using Wearing Vision Correction and Facemask
timeFrame: 2 weeks
measure: Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask
timeFrame: Baseline
measure: Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask
timeFrame: 2 weeks
measure: Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask
timeFrame: Baseline
measure: Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask
timeFrame: 2 weeks
measure: Difficulty in Socializing When Using Wearing Vision Correction and Facemask
timeFrame: Baseline
measure: Difficulty in Socializing When Using Wearing Vision Correction and Facemask
timeFrame: 2 weeks
measure: Physical Safety Concerns When Wearing Your Vision Correction and Facemask
timeFrame: Baseline
measure: Physical Safety Concerns When Wearing Your Vision Correction and Facemask
timeFrame: 2 weeks
measure: Emotional Impact of Using the Facemask When Wearing Your Vision Correction
timeFrame: Baseline
measure: Emotional Impact of Using the Facemask When Wearing Your Vision Correction
timeFrame: 2 weeks
measure: Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction
timeFrame: Baseline
measure: Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research
Study officials:
affiliation: Eurolens Research
name: Carole Maldonado-Codina
role: PRINCIPAL_INVESTIGATOR
References: