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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Respiratory Tract Infections; COVID-19
• Intervention / Treatment: Behavioral: Wearing glasses (any type)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 25000
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Atle Fretheim, PhD; Phone Number: +4791649828; Email: atle.fretheim@fhi.no
• Study Contact Backup: Name: Arnfinn Helleve, PhD; Email: arnfinn.helleve@fhi.no

Study Locations

• Norway
  • Oslo, Norway, 0213
    • Recruiting
    • Norwegian Institute of Public Health
    • Contact: Atle Fretheim, PhD MD; Email: atle.fretheim@fhi.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Glasses; 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.).	Behavioral: Wearing glasses (any type); Participants are asked to wear glasses in public spaces.
No Intervention: Not glasses; 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.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive test for SARS-CoV-2	We 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Health care use (all causes)	Routinely collected data (KPR and NPR databases)	Day 1 to 21
Any positive COVID-19 test result	Self report	Day 1 to 17
Respiratory symptoms	Self report	Day 1 to 17
Health care use for respiratory symptoms	Self report	Day 1 to 17
Health care use for injuries	Self report	Day 1 to 17
Health care use (all causes)	Self report	Day 1 to 17

Collaborators and Investigators

• Sponsor: Norwegian Institute of Public Health
• Collaborators: University of Basel
• Investigators: Principal Investigator: Atle Fretheim, PhD, Head of Centre for Epidemic Interventions Research (CEIR)

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2021
• Primary Completion (Anticipated): May 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: January 31, 2022
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 1, 2022

Study Record Updates

• Last Update Posted (Actual): April 20, 2022
• Last Update Submitted That Met QC Criteria: April 19, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: COVID-19 Prevention Protection
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Respiratory Tract Infections
• Other Study ID Numbers: P360-22/00592

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

From protocol:

The researchers intend to give full access to the full protocol, participant-level dataset, and statistical code, to anyone who is interested, after securing that the dataset is fully anonymized.

• IPD Sharing Time Frame: The investigators expect to be able to share unidentifiable dataset with partners inside the European Union (EU) by May 2022, and an anonymous dataset for wide distribution at a later stage.
• IPD Sharing Access Criteria: Data that are not fully anonymized will only be shared within the EU (due to data protection regulations).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No