Actively Recruiting
Clinical Cohort Study of Different Subtypes of Primary Sjogren Syndrome Related Dry Eye
Led by Peking University Third Hospital · Updated on 2022-11-04
500
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to better understand primary Sjögren's syndrome related dry eye (pSS-DED), a chronic autoimmune condition affecting tear-producing glands and causing dry eye symptoms. The study focuses on patients with different subtypes of dry eye associated with primary Sjögren's syndrome and explores links between affected organs, tear fluid and blood biomarkers, and disease severity and progression. The goal is to develop a new perspective on diagnosis, classification, and treatment of pSS-DED. Participants include dry eye patients visiting a specialized clinic from 2021 to 2028. Those diagnosed with pSS-DED also meet established criteria for primary Sjögren's syndrome. The study observes and collects data without assigning treatments, but one intervention involved is cyclosporine eye drops. Patients are divided into groups based on their dry eye subtype including those with and without primary Sjögren's syndrome. Throughout the study period, from 2021 to 2028, participants undergo regular assessments including evaluation of disease activity using the ESSDAI score, tear production measured by Schirmer test, and tear film stability assessed by break-up time and tear meniscus height. Researchers collect tear fluid and blood samples to analyze biomarkers and monitor ocular symptoms and progression. The study includes patients aged 18 to 80 years and also enrolls healthy volunteers for comparison.
CONDITIONS
Brief Title
Clinical Cohort Study in Patients With Different Subtypes of Primary Sjogren Syndrome Related Dry Eye
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must meet the TFOS DEWS II criteria for dry eye disease
- Participants in the primary Sjögren's syndrome dry eye (pSS-DED) group must meet the 2016 ACR/EULAR pSS diagnosis and classification consensus
You will not qualify if you...
- Diagnosis of any rheumatic or systemic disease other than primary Sjögren's syndrome that affects tear function
- History of eye trauma or surgery
- History of wearing contact lenses
- Presence of other eye conditions such as acute inflammation, infection, glaucoma, or eyelid abnormalities
- Inability to cooperate or complete related examinations
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From 2021 to January 2028
Participants with primary Sjögren's syndrome related dry eye and other dry eye subtypes are observed to explore associations between affected organs, tear fluid and blood biomarkers, and symptom progression.
Regular assessments during clinic visits from 2021 to 2028
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yun Feng, PhD
W
Weizhen Zeng
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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