In this trial the researchers plan to recruit 25,000 volunteers to be randomly allocated either wearing sunglasses or ordinary glasses in public spaces where they are close to other people, or not wear glasses in such circumstances. For each participant the trial period is 2 weeks, after which they will be asked to complete a brief questionnaire which includes questions about results of COVID-19 tests during the trial period.
A systematic review of observational studies indicated that eye protection may be an effective measure to prevent SARS-CoV-2 infections. Randomized trials are needed to assess whether the observed associations are caused by protection of the eye or confounding factors such as other systematic differences between users and non-users of eye protection, co-interventions, or changes in COVID-19 incidence when comparisons were done over time. This is a pragmatic, virtual, parallel group, 1:1 randomized, superiority trial. The researchers will recruit and randomize participants via an online portal. The trial will be fully remote and virtual without any personal interaction between investigators and participants. All members of the public are eligible who confirm that they are at least 18 years of age, do not regularly wear glasses, have not contracted COVID-19 since December 15th 2021, and are willing to be randomized to wear, or not wear glasses in public when close to other people, for a 2-week period. Persons who are dependent on visual aids but typically use contact lenses are eligible. The participants will be randomized (1:1) to wear glasses (sunglasses or other types of glasses) in public spaces when close to others (public transport, shopping centers etc.), or to the control group. The control group will be asked not to wear glasses in public spaces when close to others. The primary outcome is positive test for COVID-19. The researchers aim to include about 25,000 participants to have a statistical power of 80% to detect a relative risk reduction of 25% for the primary outcome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
3,717
Participants are asked to wear glasses in public spaces.
Norwegian Institute of Public Health
Oslo, Norway
Positive test for SARS-CoV-2
The investigators will compare the incidence of notified cases of COVID-19 (i.e. registered positive SARS-CoV-2 tests).
Time frame: Days 3 to 17 after start of trial period.
Health care use for respiratory symptoms
Routinely collected data (Norwegian Registry for Primary Health Care (KPR) and Norwegian Patient Registry (NPR) databases)
Time frame: Day 1 to 28
Health care use for injuries health care use (all causes) from day 1 to day 21 (data source: KPR and NPR
Routinely collected data (KPR and NPR databases)
Time frame: Day 1 to 21
Health care use (all causes)
Routinely collected data (KPR and NPR databases)
Time frame: Day 1 to 21
Any positive COVID-19 test result
Self report
Time frame: Day 1 to 17
Respiratory symptoms
Self report
Time frame: Day 1 to 17
Health care use for respiratory symptoms
Self report
Time frame: Day 1 to 17
Health care use for injuries
Self report
Time frame: Day 1 to 17
Health care use (all causes)
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Self report
Time frame: Day 1 to 17