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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05476068
Other study ID # [2022]NO.(001).
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 20, 2022
Est. completion date May 25, 2022

Study information

Verified date July 2022
Source Second Affiliated Hospital of Nanchang University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1807
Est. completion date May 25, 2022
Est. primary completion date May 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility Inclusion criteria: - 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 Exclusion criteria: - 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

Study Design


Locations

Country Name City State
China The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi

Sponsors (1)

Lead Sponsor Collaborator
Yifeng Yu

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). DAY 0
Primary 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). DAY 0
Primary 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). DAY 0
Secondary 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). DAY 0
Secondary 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 DAY 0
Secondary 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. DAY 0
See also
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