Penn SICCA Follow-up Study (PSFS)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dry Eye; Sjogren's Syndrome

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.

• Study Type: Observational
• Enrollment (Estimated): 220

Contacts and Locations

• Study Contact: Name: Emma Iacobucci; Phone Number: 215-662-9393; Email: Emma.Iacobucci@Pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Scheie Eye Institute
      • Contact: Vatinee Bunya, MD; Phone Number: 215-662-9393; Email: Vatinee.bunya@pennmedicine.upenn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects who meet the inclusion/exclusion criteria for this study will be contacted to ask if they would be willing to participate. All recruited participants, who participated in the previous SICCA study at the University of Pennsylvania will be identified.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Collection of specimens and clinical information	To collect specimens (saliva, tears, conjunctival cells, and blood) and clinical information on dry eye patients with or without Sjogren's syndrome	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Investigators: Principal Investigator: Vatinee Bunya, MD, Scheie Eye Institute

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029

Study Registration Dates

• First Submitted: September 14, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 24, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 27, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Lacrimal Apparatus Diseases; Skin and Connective Tissue Diseases; Sjogren's Syndrome; Dry Eye Syndromes
• Other Study ID Numbers: 827285

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No