Glasses Against Transmission of SARS-CoV-2 (COVID-19) in the Community (GLASSY)

Norwegian Institute of Public Health

Status: Completed

Conditions: COVID-19; Respiratory Tract Infections

Treatments: Behavioral: Wearing glasses (any type)

Study type: Interventional

Funder types: Other

Identifiers

NCT05217797

P360-22/00592

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,717 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3,717 participants in 2 patient groups

Glasses

Experimental group

Description:

Participants in the experimental arm are asked to wear glasses (sunglasses or other glasses) when outside their home and close to others (e.g. on public transport, in shopping centres etc.).

Treatment:

Behavioral: Wearing glasses (any type)

Not glasses

No Intervention group

Description:

Participants in no interventions arm are asked to not wear glasses (sunglasses or other glasses) when outside their home and close to others (e.g. on public transport, in shopping centres etc.).