Dry Eye SymptomsNCT05476068

Dry Eye Under China's Dynamic COVID-zero Strategy

An observational study of Dry Eye Symptoms, run by Yifeng Yu at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To compare the prevalence of dry eye symptoms and to investigate the association of the risk factors with the dry eye symptomatology among university students in the epidemic and non-epidemic areas of China under the COVID-zero strategy. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Dry Eye Symptoms
How many people: 1,807 participants
Where: 1 siteChina
Study dates: 20 Mar 2022to 25 May 2022
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 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Study population: The subjects of the study are students from Nanchang University and Henan University.

Who may be able to join

College students with age ≥18 years
No other medication history in recent 2 weeks;
Have high compliance and are willing to fill in the questionnaire on time

Who cannot join

routinely using artificial tears and Other eye drops;
taking any medication that could interfere with the results of the study;
with any history of eye surgery

Trial locations and contacts

1 site in 1 country.

China1 site

The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330000

Other trials in China

About this study

Official title: Dry Eye Symptoms of University Students Under China's Dynamic COVID-zero Strategy: A Comparison Between the Epidemic and Non-epidemic Areas

Read the detailed description

As the COVID-19 outbreak at the end of 2019 spread around the world, the World Health Organization declared it a public health emergency of international concern on 30th January, and a global pandemic on 1st March. In addition to the threat of coronavirus itself, anti-epidemic measures such as wearing masks, maintaining social distance, prohibiting group gathering, blockade, isolation, curfew, closure, working at home, online learning, etc., have also greatly changed people's daily life dynamics. Unlike the previous regional blockade (city-wide) suspension of school and work, China has shifted to dynamic prevention and control in April 2020, and the basic life and activities in the epidemic area are not restricted. This study aims to compare the prevalence of dry eye symptoms and to investigate the association of the risk factors with dry eye symptoms among college students in the epidemic and non-epidemic areas of China under the dynamic COVID-zero strategy.

Conditions: Dry Eye Symptoms
Keywords: dry eye symptoms, anxiety, depression
Medical subject headings: Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT05476068
Study group	Role	What they receive
Epidemic area (Nanchang, Nanchang university)		Not described
Non-epidemic area (Kaifeng, Henan university)		Not described

What is being measured

The primary outcome is the main question the study is designed to answer.

A score of ocular surface disease index (OSDI)questionnaire
Ocular surface disease index (OSDI)questionnaire : (1) OSDI: ≤12 (no DED symptoms), 13 ≤ d ≤ 22 (mild DED symptoms), 23 ≤ d ≤ 32 (moderate DED symptoms), and ≥33 (severe DED symptoms).
Measured: DAY 0
A score of GAD-7 questionnaire
GAD-7 questionnaire: (1) 0 < GAD-7 ≤ 4 (normal), 5 ≤ GAD-7 ≤ 9 (mild anxiety), 10 ≤ GAD-7 ≤ 13 (moderate anxiety), 14 ≤ GAD-7 ≤ 18 (moderate and severe anxiety), and 19 ≤ GAD-7 ≤ 21 (severe anxiety).
Measured: DAY 0
A score of PHQ-9 questionnaire
PHQ-9 questionnaire: (1) 0 < PHQ-9 ≤ 4 (normal), 5 ≤ GAD-7 ≤ 9 (mild depression), 10 ≤ GAD-7 ≤ 14 (moderate depression), 15 ≤ GAD-7 ≤ 19 (moderate and severe depression), and 20 ≤ GAD-7 ≤ 27 (severe depression).
Measured: DAY 0

Secondary outcomes (3)

A score of UCLA Loneliness Scale questionnaire
UCLA Loneliness Scale Questionnaire: (1) UCLA < 28 (low loneliness), 28 ≤ UCLA ≤ 33 (generally lower), 33 < UCLA ≤ 39 (intermediate level), 39 < UCLA ≤ 44 (generally higher), and GAD-7 > 44 (highly lonely).
Measured: DAY 0
Students' increased use of mobile phones
Students choose to increase the time of using mobile phones according to options: 0 hours, less than 1 hour, 1-3 hours, 3-5 hours, 5-7 hours, and more than 7 hours
Measured: DAY 0
Frequency of student sports
Students choose the frequency of sports according to the options, which are: less than once a month, 2-3 times a month, 1-2 times a week, 3-5 times a week, and once a day.
Measured: DAY 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 202225 May 2022

First posted27 Jul 2022
Study start20 Mar 2022
Primary completion20 May 2022
Study completion25 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Dry Eye SymptomsStudies 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: Other
Time perspective: Other
Enrolment: 1,807 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05476068
Sponsor's protocol ID: [2022]NO.(001).
Status last verified: Jul 2022
First submitted: 23 Jul 2022
Last updated: 27 Jul 2022
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye Symptoms trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Dry Eye Symptoms of University Students Under China's Dynamic COVID-zero Strategy: A Comparison Between the Epidemic and Non-epidemic Areas
ClinicalTrials.gov ID: NCT05476068
Acronym / sponsor ID: [2022]NO.(001).
Conditions: Dry Eye Symptoms
Keywords: dry eye symptoms, anxiety, depression
Study type: Observational
Recruitment status: Completed
Enrolment: 1,807 participants (actual)
Lead sponsor: Yifeng YuUniversity, hospital or other
Study start: 20 Mar 2022 (actual)
Primary completion: 20 May 2022 (actual)
Study completion: 25 May 2022 (actual)
First posted: 27 Jul 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.

Detailed description

Study design

Observational model: Other
Time perspective: Other
Number of arms: 2

Arm	Type	Receives
Epidemic area (Nanchang, Nanchang university)	–	–
Non-epidemic area (Kaifeng, Henan university)	–	–

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult
Study population: The subjects of the study are students from Nanchang University and Henan University.

Key inclusion criteria (3 listed)

College students with age ≥18 years
No other medication history in recent 2 weeks;
Have high compliance and are willing to fill in the questionnaire on time

Key exclusion criteria (3 listed)

routinely using artificial tears and Other eye drops;
taking any medication that could interfere with the results of the study;
with any history of eye surgery

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

A score of ocular surface disease index (OSDI)questionnaire
Time frame: DAY 0
Ocular surface disease index (OSDI)questionnaire : (1) OSDI: ≤12 (no DED symptoms), 13 ≤ d ≤ 22 (mild DED symptoms), 23 ≤ d ≤ 32 (moderate DED symptoms), and ≥33 (severe DED symptoms).
A score of GAD-7 questionnaire
Time frame: DAY 0
GAD-7 questionnaire: (1) 0 < GAD-7 ≤ 4 (normal), 5 ≤ GAD-7 ≤ 9 (mild anxiety), 10 ≤ GAD-7 ≤ 13 (moderate anxiety), 14 ≤ GAD-7 ≤ 18 (moderate and severe anxiety), and 19 ≤ GAD-7 ≤ 21 (severe anxiety).
A score of PHQ-9 questionnaire
Time frame: DAY 0
PHQ-9 questionnaire: (1) 0 < PHQ-9 ≤ 4 (normal), 5 ≤ GAD-7 ≤ 9 (mild depression), 10 ≤ GAD-7 ≤ 14 (moderate depression), 15 ≤ GAD-7 ≤ 19 (moderate and severe depression), and 20 ≤ GAD-7 ≤ 27 (severe depression).

3 secondary outcomes

A score of UCLA Loneliness Scale questionnaire
Time frame: DAY 0
Students' increased use of mobile phones
Time frame: DAY 0
Frequency of student sports
Time frame: DAY 0

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 27 Jul 2022.
Individual participant dataSharing planned: No

Related trials for Dry Eye Symptoms

RecruitingPhase 2
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Sjogren's Syndrome
RecruitingPhase 3
Two Arm, Double-blind, Phase III Study Assessing Efficacy and Safety of Ianalumab Versus Placebo, in Participants With Sjögren's Disease With High Symptom Burden
Sjögren´s Disease
Not yet recruitingPhase 4
Effect of Acoltremon Ophthalmic Solution 0.003% on Tear Production and Symptoms in Patients With Tear Deficiency and Concurrent Neuropathic Corneal Pain
Ocular Pain, Dry Eye
Enrolling by invitationObservational study
Comparative Autoantibody and Immunologic Cell Marker Study
Autoimmune Diseases, Lupus Erythematosus, Systemic
Recruiting
Fatigue in Sjögren's Syndrome: 3 Therapeutic Strategies
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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.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Dry Eye Symptoms, run by Yifeng Yu at 1 site in China.

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 3 inclusion and 3 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 27 Jul 2022. 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 China. 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?

A score of ocular surface disease index (OSDI)questionnaire (time frame: DAY 0). The study lists 3 primary outcomes in all. 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 NCT05476068.

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 27 Jul 2022.