Penn SICCA Follow-up Study

NCT05056012 | Not Yet Recruiting

• 1 other identifier: 827285
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dry Eye; Sjogren's Syndrome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Ocular surface exam findings

  2 years

• Serologic testing

  2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Previously participated in the SICCA study at Penn
• Be 18 years or older
• \. Have signed an IRB consent form agreeing to the terms of the study

You may not qualify if:

• Did not previously participate in SICCA study at Penn
• Under the age of 18 years

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Scheie Eye Institute

Philadelphia, Pennsylvania, 19104, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Subjects will provide approximately 7 tablespoons of blood, which may be used for serology, isolation of DNA and isolation of lymphocytes. Subject will have whole saliva sampling performed. These procedures are standardized and validated procedures routinely used for the evaluation of Sjogren's syndrome. Impression cytology may be performed by numbing the ocular surface with drops and then applying a membrane to the conjunctival surface of each eye and the membranes will be stored. A standard Schirmer test will also be performed and strips will be stored after test completion.

MeSH Terms

Conditions

Dry Eye Syndromes; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Vatinee Bunya, MD

  Scheie Eye Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emma Iacobucci

CONTACT

215-662-9393; Emma.Iacobucci@Pennmedicine.upenn.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director of Penn Dry Eye & Ocular Surface Center

Study Record Dates

• First Submitted: September 14, 2021
• First Posted: September 24, 2021
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

US (1)