Clinical trial NCT05217797: Glasses Against Transmission of SARS-CoV-2 (COVID-19) in the Community
Official title: The GLasses Against Transmission of SARS-CoV-2 (COVID-19) in the communitY (GLASSY) Trial: A Pragmatic Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Respiratory Tract Infections
Keywords: COVID-19 Prevention Protection
Lead sponsor: Norwegian Institute of Public Health
Sponsor class: OTHER_GOV
Collaborators: name: University of Basel
First posted: 2022-02-01
Enrollment: 3717
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Sequence generation We will use a simple 1:1 randomization by means of computer-generated random numbers.

The allocation will be concealed as the participant themselves will be directly informed of their allocation as soon as they have agreed to take part in the trial and have completed the online consent form. Generation of allocation sequence, enrolment of participants and assignment of participants will all be handled by the digital recruitment platform.
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* owns or can borrow glasses that can be used (e.g. sun-glasses)
* willing to be randomized to wear, or not wear glasses outside the home when close to others, for a 2-week period.
* provides informed consent

Exclusion Criteria:

* does regularly wear glasses (contact lenses are accepted)
* contracted COVID-19 after December 15th 2021.

Primary outcomes:
measure: Positive test for SARS-CoV-2
timeFrame: Days 3 to 17 after start of trial period.
Secondary outcomes:
measure: Health care use for respiratory symptoms
timeFrame: Day 1 to 28
measure: Health care use for injuries health care use (all causes) from day 1 to day 21 (data source: KPR and NPR
timeFrame: Day 1 to 21
measure: Health care use (all causes)
timeFrame: Day 1 to 21
measure: Any positive COVID-19 test result
timeFrame: Day 1 to 17
measure: Respiratory symptoms
timeFrame: Day 1 to 17
measure: Health care use for respiratory symptoms
timeFrame: Day 1 to 17
measure: Health care use for injuries
timeFrame: Day 1 to 17
measure: Health care use (all causes)
timeFrame: Day 1 to 17
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian Institute of Public Health
Study officials:
affiliation: Head of Centre for Epidemic Interventions Research (CEIR)
name: Atle Fretheim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fretheim A, Elgersma IH, Helleve A, Elstrom P, Kacelnik O, Hemkens LG. Effect of Wearing Glasses on Risk of Infection With SARS-CoV-2 in the Community: A Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2244495. doi: 10.1001/jamanetworkopen.2022.44495.