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Completed

NCT Number: NCT05217797

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

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian Institute of Public Health

Oslo, 0213, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Wearing glasses (any type)

Behavioral

Participants are asked to wear glasses in public spaces.

Primary outcomes

  1. Positive test for SARS-CoV-2

    Time frame: Days 3 to 17 after start of trial period.

    The investigators will compare the incidence of notified cases of COVID-19 (i.e. registered positive SARS-CoV-2 tests).

Secondary outcomes

  1. Health care use for respiratory symptoms

    Time frame: Day 1 to 28

    Routinely collected data (Norwegian Registry for Primary Health Care (KPR) and Norwegian Patient Registry (NPR) databases)

  2. Health care use for injuries health care use (all causes) from day 1 to day 21 (data source: KPR and NPR

    Time frame: Day 1 to 21

    Routinely collected data (KPR and NPR databases)

  3. Health care use (all causes)

    Time frame: Day 1 to 21

    Routinely collected data (KPR and NPR databases)

  4. Any positive COVID-19 test result

    Time frame: Day 1 to 17

    Self report

  5. Respiratory symptoms

    Time frame: Day 1 to 17

    Self report

  6. Health care use for respiratory symptoms

    Time frame: Day 1 to 17

    Self report

  7. Health care use for injuries

    Time frame: Day 1 to 17

    Self report

  8. Health care use (all causes)

    Time frame: Day 1 to 17

    Self report

Sponsors and collaborators

Lead sponsor

Norwegian Institute of Public Health

Other Gov

Collaborators

  • University of Basel

Registry information

Official study title

The GLasses Against Transmission of SARS-CoV-2 (COVID-19) in the communitY (GLASSY) Trial: A Pragmatic Randomized Trial

Acronym: GLASSY

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 1, 2022
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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