Observational study on dry eye in patients with primary Sjögren's syndrome
Clinical Cohort Study in Patients With Different Subtypes of Primary Sjogren Syndrome Related Dry Eye
This study looks at people with primary Sjögren's syndrome who have severe dry eye symptoms to see how their condition affects their eyes and what can be learned from their tear and blood samples.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Peking University Third Hospital Academic / other |
| Locations | 1 site (Beijing) |
| Trial ID | NCT05605314 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with primary Sjögren's syndrome (pSS) who experience severe dry eye symptoms. It aims to establish a clinical cohort to explore the relationship between the primary organs affected by pSS and various biomarkers in tear fluid and blood. By analyzing these associations, the study seeks to enhance understanding of the pathogenesis, diagnosis, classification, and treatment of dry eye disease related to pSS. The research will also investigate the severity of ocular involvement and symptom progression in these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with primary Sjögren's syndrome who experience dry eye symptoms.
Not a fit: Patients with other rheumatic or systemic diseases affecting tear function, or those with a history of ocular trauma or surgery, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnosis and treatment strategies for patients suffering from dry eye related to primary Sjögren's syndrome.
How similar studies have performed: While there is limited research specifically on dry eye in pSS, similar studies on autoimmune conditions have shown promise in understanding disease mechanisms and improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * (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.
Where this trial is running
Beijing
- Peking University Third Hospital — Beijing, China (Recruiting)
Study contacts
- Study coordinator: Yun Feng, PhD
- Email: superjune@sina.com
- Phone: 13911572425
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.