Clinical Cohort Study in Patients With Different Subtypes of Primary Sjogren Syndrome Related Dry Eye
pSS
1 other identifier
observational
500
1 country
1
Brief Summary
Primary Sjögren's syndrome is a chronic autoimmune disease that primarily involves exocrine glands, most commonly manifested in dry eye, dry mouth, and in other systems of the body.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2021
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 30, 2022
CompletedFirst Posted
Study publicly available on registry
November 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2028
November 4, 2022
September 1, 2022
6 years
October 30, 2022
October 30, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
ESSDAI
Fill out the scale
2021.1~2028.1
Secondary Outcomes (2)
Schirmer
2021.1~2028.1
BUT，TMH
2021.1~2028.1
Study Arms (2)
pSS-DED
DED patients who visited the dry eye clinic of Peking University Third Hospital from 2021 to May 2028. The pSS-DED patients further accepted the diagnosis of rheumatology department. All enrolled DED participants met the criterion of TFOS DEWS II Definition and Classification Report and pSS-DED group also met 2016ACR/EULAR pSS diagnosis and classification consensus.
nss-DED
DED patients who visited the dry eye clinic of Peking University Third Hospital from 2021 to May 2028.
Interventions
Eligibility Criteria
pSS and DED patients who visited the dry eye clinic of Peking University Third Hospital from January 2021 to January 2028.
You may qualify if:
- All enrolled DED participants met the criterion of TFOS DEWS II Definition and Classification Report and pSS-DED group also met 2016ACR/EULAR pSS diagnosis and classification consensus.
You may not qualify if:
- (1) patients were diagnosed as any rheumatic or systematic diseases that would probably affect tear function except for pSS and DED. (2) had a history of ocular trauma or surgery. (3) had a history of wearing contact lens. (4) had concomitant ocular lesions such as acute inflammation or infection, glaucoma or eyelid abnormalities. (5) cannot cooperate properly or finish related examinations.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University Third Hospital
Beijing, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Liyuan Tao, PhD
Peking University Third Hospital
Central Study Contacts
Weizhen Zeng
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2022
First Posted
November 4, 2022
Study Start
January 1, 2021
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2028
Last Updated
November 4, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share