N/A Completed N=30 Randomized Treatment

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

Myopia

Source: ClinicalTrials.gov NCT04658797 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2021

Primary outcomePrimary: Visual Acuity - High Contrast — -0.06; -0.07 logMAR

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Visual Acuity - High Contrast	-0.08; -0.08	—
PRIMARY Visual Acuity - Low Contrast	0.20; 0.21	—
PRIMARY Subjective Response on Facemask Usability Questionnaire - Breathability	5; 1; 5; 5; 5; 6	—
PRIMARY Subjective Response on Facemask Usability Questionnaire - Heat	1; 0; 2; 6; 3; 4	—
PRIMARY Subjective Response on Facemask Usability Questionnaire -Heat	3; 1; 6; 2; 4; 4	—
PRIMARY Subjective Response on Facemask Usability Questionnaire - Tightness	2; 2; 7; 7; 4; 5	—
PRIMARY Subjective Response on Facemask Usability Questionnaire -Tightness	4; 0; 7; 10; 3; 5	—
PRIMARY Subjective Response on Facemask Usability Questionnaire - Ease in Talking	2; 1; 3; 6; 4; 5	—
PRIMARY Subjective Response on Facemask Usability Questionnaire -Ease in Talking	3; 1; 4; 4; 4; 6	—
PRIMARY Subjective Response on Facemask Usability Questionnaire - Comfort on Ear Lobes	6; 4; 5; 6; 3; 2	—
PRIMARY Subjective Response on Facemask Usability Questionnaire - Overall Comfort	3; 0; 6; 4; 5; 7	—
PRIMARY Difficulty in Walking When Using Wearing Vision Correction and Facemask	11; 3; 4; 3; 0; 3	—
PRIMARY Difficulty in Driving When Using Wearing Vision Correction and Facemask	3; 0; 1; 2; 0; 2	—
PRIMARY Difficulty in Reading When Using Wearing Vision Correction and Facemask	9; 2; 3; 4; 3; 3	—
PRIMARY Difficulty in Working With a Computer When Using Wearing Vision Correction and Facemask	7; 3; 3; 3; 3; 3	—
PRIMARY Difficulty in Exercising (Physical Activities) When Using Wearing Vision Correction and Facemask	6; 0; 4; 0; 3; 0	—
PRIMARY Difficulty in Socializing When Using Wearing Vision Correction and Facemask	6; 2; 5; 2; 1; 4	—
PRIMARY Physical Safety Concerns When Wearing Your Vision Correction and Facemask	12; 9; 3; 3; 0; 1	—
PRIMARY Emotional Impact of Using the Facemask When Wearing Your Vision Correction	8; 6; 6; 6; 1; 3	—
PRIMARY Impact of Using the Facemask on Your Personal Appearance When Wearing Your Vision Correction	7; 3; 6; 8; 2; 3	—

Eligibility Criteria

Inclusion Criteria

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.
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.

Exclusion Criteria

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.
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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04658797). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.