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

COVID-19 Clinical Trial

— GLASSY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05217797
• Other study ID #: P360-22/00592
• Status: Completed
• Phase: N/A
• Start date: February 2, 2021
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2023
• Source: Norwegian Institute of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3717
• Est. completion date: December 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• Respiratory Tract Infections

Intervention

Behavioral:
• Wearing glasses (any type)
Participants are asked to wear glasses in public spaces.

Locations

Country	Name	City	State
Norway	Norwegian Institute of Public Health	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian Institute of Public Health	University of Basel

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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.20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Days 3 to 17 after start of trial period.
Secondary	Health care use for respiratory symptoms	Routinely collected data (Norwegian Registry for Primary Health Care (KPR) and Norwegian Patient Registry (NPR) databases)	Day 1 to 28
Secondary	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)	Day 1 to 21
Secondary	Health care use (all causes)	Routinely collected data (KPR and NPR databases)	Day 1 to 21
Secondary	Any positive COVID-19 test result	Self report	Day 1 to 17
Secondary	Respiratory symptoms	Self report	Day 1 to 17
Secondary	Health care use for respiratory symptoms	Self report	Day 1 to 17
Secondary	Health care use for injuries	Self report	Day 1 to 17
Secondary	Health care use (all causes)	Self report	Day 1 to 17

External Links

•   Main publication from study