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

Dry Eye Clinical Trial

— pSS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05605314
• Other study ID #: fengyun77470
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: January 1, 2028

Study information

• Verified date: September 2022
• Source: Peking University Third Hospital
• Contact: Yun Feng, PhD
• Phone: 13911572425
• Email: superjune[@]sina.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: January 1, 2028
• Est. primary completion date: January 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Sjogren's Syndrome

Intervention

Other:
• Cyclosporine
eye drop

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ESSDAI	Fill out the scale	2021.1~2028.1
Secondary	Schirmer	The Schirmer I test was performed without topical anesthesia after all other examinations by slit lamp had been completed at least 15 minutes to avoid any effect of keratoconjunctival staining. A Schirmer test strip (Liaoning Meizilin Pharmaceutical Co., Ltd.) was placed on the outer one third of the temporal lower conjunctival fornix for 5 min. The strip was then removed, and the length of the wet filter paper was recorded in millimeters.	2021.1~2028.1
Secondary	BUT,TMH	All participants were instilled a minimal volume fluorescein into the inferior temporal tear meniscus by fluorescein sodium ophthalmic test paper (Liaoning Meizilin Pharmaceutical Co., Ltd.) for the evaluation of tear menicus height (TMH) and fluorescein tear break-up time (FBUT) during slit lamp examination. Then, patients were asked to blink several times to ensure adequate mixing of the fluorescein dye with the tears. Under the cobalt blue light of the slit lamp microscope, TMH were recorded and the time interval between the last complete blink and the appearance of the first corneal dark spot was timed using a stopwatch. The average of three measurements was recorded as the FBUT.	2021.1~2028.1