Dry Eye SyndromesNCT04744805
Mask-associated Dry Eye Symptoms in China
An observational study of Dry Eye Syndromes, run by Tianjin Eye Hospital.
Trial summary
To review the relationship of increased face mask usage arising from lockdown measures instituted during the COVID-19 pandemic with dry eye symptoms on Chinese people, and make recommendations for mitigating potential detrimental effects on dry eye symptoms. Read more about this study
- Who is it for?
- Ages 6 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- face mask or not
- How many people
- 6,262 participants
- Where
- No sites listed yet
- Study dates
- 29 Jan 2021to 6 Feb 2021
- Phase
- Observational
- 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 6 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: An online survey of persons focused on face mask usage
Who may be able to join
- age >=8 years mental health
Who cannot join
- eye diseases mental or systemic diseases
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Mask-associated Dry Eye Symptoms: an Online Survey of 6262 Chinese Persons
To review the relationship of increased face mask usage arising from lockdown measures instituted during the COVID-19 pandemic with dry eye symptoms on Chinese people, and make recommendations for mitigating potential detrimental effects on dry eye symptoms.
- Conditions
- Dry Eye Syndromes
- Being tested
- face mask or not
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
face mask or notOther
long term face mask wear
| Study group | Role | What they receive |
|---|---|---|
| mask wear | Not described Receives: Other: face mask or not | |
| dry eye | Not described Receives: Other: face mask or not |
What is being measured
The primary outcome is the main question the study is designed to answer.
time of face mask wear
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start29 Jan 2021 (estimated)
- Primary completion5 Feb 2021 (estimated)
- Study completion6 Feb 2021 (estimated)
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 Dry Eye SyndromesStudies 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 6,262 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Wang, director, Study director, Tianjin Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04744805
- Sponsor's protocol ID
- 2021003
- Status last verified
- Feb 2021
- First submitted
- 4 Feb 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fan Q, Liang M, Kong W, Zhang W, Wang H, Chu J, Fang X, Song Y, Gao W, Wang Y. Wearing face masks and possibility for dry eye during the COVID-19 pandemic. Sci Rep. 2022 Apr 13;12(1):6214. doi: 10.1038/s41598-022-07724-0.
PubMed 35418586
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mask-associated Dry Eye Symptoms: an Online Survey of 6262 Chinese Persons
- ClinicalTrials.gov ID
- NCT04744805
- Acronym / sponsor ID
- 2021003
- Conditions
- Dry Eye Syndromes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,262 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 29 Jan 2021 (estimated)
- Primary completion
- 5 Feb 2021 (estimated)
- Study completion
- 6 Feb 2021 (estimated)
- First posted
- 9 Feb 2021 (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.
To review the relationship of increased face mask usage arising from lockdown measures instituted during the COVID-19 pandemic with dry eye symptoms on Chinese people, and make recommendations for mitigating potential detrimental effects on dry eye symptoms.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mask wear | – | Other: face mask or not |
| dry eye | – | Other: face mask or not |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- An online survey of persons focused on face mask usage
Key inclusion criteria (1 listed)
- age >=8 years mental health
Key exclusion criteria (1 listed)
- eye diseases mental or systemic diseases
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 |
|---|---|---|
| face mask or notlong term face mask wear | Other | dry eye, mask wear |
Primary outcome
time of face mask wear
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Derived from this study: PubMed 35418586Fan Q, Liang M, Kong W, Zhang W, Wang H, Chu J, Fang X, Song Y, Gao W, Wang Y. Wearing face masks and possibility for dry eye during the COVID-19 pandemic. Sci Rep. 2022 Apr 13;12(1):6214. doi: 10.1038/s41598-022-07724-0.
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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.
Yan Wang, director study director
Tianjin Eye Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Syndromes, run by Tianjin Eye Hospital.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yan Wang, director (+862227313336, wangyan7143@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time of face mask wear (time frame: 3 months). 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 NCT04744805, 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 9 Feb 2021.