NCT05605314

Clinical Cohort Study in Patients With Different Subtypes of Primary Sjogren Syndrome Related Dry Eye

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Peking University Third Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed description

Patients usually first seek for the ophthalmologist for severe dry eye symptoms, and most clinicians are ill-informed about Sjögren's syndrome dry eye disease (SS-DED), which can lead to missed diagnoses and misdiagnoses. Clinically, there are not many types of patients with pSS and the number of in-depth studies is small. Meanwhile, there are no specific drugs for the treatment of SS-DED, and most patients need to be treated with multiple methods to understand which methods are most effective. In this study, by establishing a clinical cohort of patients with different subtypes of dry eye with pSS, we explored the association between the primary organs affected by pSS and various biomarkers related to tear fluid and blood, and the association between the primary organs affected by pSS, tear components and blood markers and the severity of ocular involvement, symptom progression and prognosis. This study initially constructs a special cohort of patients with pSS ocular involvement, which may explain its pathogenesis from a new perspective in diagnose, classification and treatment.

Conditions

• Dry Eye

Interventions

Type	Name	Description
OTHER	Cyclosporine	eye drop

Timeline

• Start date: 2021-01-01
• Primary completion: 2027-01-01
• Completion: 2028-01-01
• First posted: 2022-11-04
• Last updated: 2022-11-04

Locations

1 site across 1 country: China