COVID-19GLASSYNCT05217797
Glasses Against Transmission of SARS-CoV-2 (COVID-19) in the Community
A study testing Wearing glasses (any type) in people with COVID-19 and Respiratory Tract Infections, run by Norwegian Institute of Public Health at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Respiratory Tract Infections
- What is being tested?
- Wearing glasses (any type)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,717 participants
- Where
- 1 siteNorway
- Study dates
- 2 Feb 2021to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- does regularly wear glasses (contact lenses are accepted)
- contracted COVID-19 after December 15th 2021.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19, Respiratory Tract Infections
- Being tested
- Wearing glasses (any type)
- Keywords
- COVID-19 Prevention Protection
- Medical subject headings
- COVID-19, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearing glasses (any type)Behavioural
Participants are asked to wear glasses in public spaces.
| Study group | Role | What they receive |
|---|---|---|
| Glasses | Experimental | 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.). Receives: Behavioral: Wearing glasses (any type) |
| Not glasses | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Days 3 to 17 after start of trial period.
Secondary outcomes (8)
Health care use for respiratory symptoms
Routinely collected data (Norwegian Registry for Primary Health Care (KPR) and Norwegian Patient Registry (NPR) databases)
Measured: 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)
Measured: Day 1 to 21
Health care use (all causes)
Routinely collected data (KPR and NPR databases)
Measured: Day 1 to 21
Any positive COVID-19 test result
Self report
Measured: Day 1 to 17
Respiratory symptoms
Self report
Measured: Day 1 to 17
Health care use for respiratory symptoms
Self report
Measured: Day 1 to 17
Health care use for injuries
Self report
Measured: Day 1 to 17
Health care use (all causes)
Self report
Measured: Day 1 to 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start2 Feb 2021
- Primary completion1 May 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 3,717 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Institute of Public Health
- Sponsor type
- Other government
- Collaborators
- University of Basel
- Responsible party
- Sponsor
- Investigators
- Atle Fretheim, PhD, Principal investigator, Head of Centre for Epidemic Interventions Research (CEIR)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217797
- Sponsor's protocol ID
- P360-22/00592
- Acronym
- GLASSY
- Status last verified
- Nov 2023
- First submitted
- 31 Jan 2022
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 36454571
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The GLasses Against Transmission of SARS-CoV-2 (COVID-19) in the communitY (GLASSY) Trial: A Pragmatic Randomized Trial
- ClinicalTrials.gov ID
- NCT05217797
- Acronym / sponsor ID
- GLASSY / P360-22/00592
- Conditions
- COVID-19, Respiratory Tract Infections
- Keywords
- COVID-19 Prevention Protection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,717 participants (actual)
- Lead sponsor
- Norwegian Institute of Public HealthOther government
- Collaborators
- University of Basel
- Study start
- 2 Feb 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 1 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Glasses | Experimental | Behavioral: Wearing glasses (any type)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.). |
| Not glasses | No intervention | –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.). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- does regularly wear glasses (contact lenses are accepted)
- contracted COVID-19 after December 15th 2021.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearing glasses (any type)Participants are asked to wear glasses in public spaces. | Behavioural | Glasses |
Primary outcome
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).
8 secondary outcomes
Health care use for respiratory symptoms
Time frame: 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
Time frame: Day 1 to 21
Health care use (all causes)
Time frame: Day 1 to 21
Any positive COVID-19 test result
Time frame: Day 1 to 17
Respiratory symptoms
Time frame: Day 1 to 17
Health care use for respiratory symptoms
Time frame: Day 1 to 17
Health care use for injuries
Time frame: Day 1 to 17
Health care use (all causes)
Time frame: Day 1 to 17
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Results publication: PubMed 36454571Fretheim 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Atle Fretheim, PhD principal investigator
Head of Centre for Epidemic Interventions Research (CEIR)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearing glasses (any type) in people with COVID-19 and Respiratory Tract Infections, run by Norwegian Institute of Public Health at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive test for SARS-CoV-2 (time frame: Days 3 to 17 after start of trial period.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05217797, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.