Penn SICCA Follow-up Study

NCT05056012 — Not yet recruiting, 220 participants, University of Pennsylvania

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Penn Sjögren's International Clinical Collaborative Alliance (SICCA) Follow-up Study

Registry	NCT05056012, acronym PSFS
Status	Not yet recruiting
Study type	Observational
Enrollment	220 (Estimated)
Sponsor	University of Pennsylvania (Other)
Conditions	Dry Eye, Sjogren's Syndrome
Dates	start 2027-01-01 (estimated), primary completion 2029-01-01 (estimated), completion 2029-01-01 (estimated), first posted 2021-09-24, last updated 2026-03-02
Locations	1 site in United States

-Summary

This study will involve the collection of follow-up data for patients who previously participated in the Sjogren's International Clinical Collaborative Alliance (SICCA) study at the University of Pennsylvania. Clinical data and specimens will be collected from subjects with objective evidence of dry eye who were or were not diagnosed with Sjogren's syndrome at the time of their initial participation in the SICCA study. Specimens will be collected from participants which will include tears, saliva, whole blood, serum, DNA and possible labial minor salivary gland biopsies when indicated. All individuals will participate in a standard evaluation protocol including an oral, ocular and physical examination, objective tests for dry eyes and dry mouth and, whenever necessary, a labial minor salivary gland biopsy. The biopsy requirement is waived for those who have already had positive lip biopsies in the past.

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+Detailed description

General study design: This is a single center study that involves follow-up of patients who previously participated in the Sjogren's International Collaborative Clinical Alliance (SICCA) at the University of Pennsylvania. Objective evaluation of salivary function will be done by collecting unstimulated whole and stimulated parotid saliva. Objective evaluation of lacrimal function will be performed using the Schirmer test I, Lissamine Green staining, and determining tear break-up time. In a subset of patients, when indicated an objective evaluation of lymphocytic infiltration of the minor salivary glands will be performed by histologic analysis of labial salivary gland biopsies. Serum autoantibody profiles will be determined. In addition, specimens such as biopsies, saliva, sera, conjunctival cells, and tears will be collected. Standardized questionnaires will be used to gain health information.

+Outcome measures

Primary outcomes

Collection of specimens and clinical information [2 years]: To collect specimens (saliva, tears, conjunctival cells, and blood) and clinical information on dry eye patients with or without Sjogren's syndrome

Secondary outcomes

Ocular surface exam findings [2 years]: Characterize the clinical features of the ocular and oral components of dry eye patients with or without Sjogren's syndrome.
Serologic testing [2 years]: Characterize the laboratory, including serologic (including autoantibodies), features of dry eye patients with or without Sjogren's syndrome.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

1. Previously participated in the SICCA study at Penn
2. Be 18 years or older

4\. Have signed an IRB consent form agreeing to the terms of the study

Exclusion Criteria:

1. Did not previously participate in SICCA study at Penn
2. Under the age of 18 years

+Locations (1)

Facility	City	Country	Status
Scheie Eye Institute	Philadelphia, Pennsylvania	United States

+Investigators

Vatinee Bunya, MD, Principal investigator, Scheie Eye Institute