Penn SICCA Follow-up Study

NCT ID: NCT05056012

Last Updated: 2025-09-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 220 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2028-01-31

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.

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.

Conditions

Dry Eye; Sjogren's Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Vatinee Bunya, MD

Co-Director of Penn Dry Eye & Ocular Surface Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Vatinee Bunya, MD

Role: PRINCIPAL_INVESTIGATOR

Scheie Eye Institute

Locations

Scheie Eye Institute

Philadelphia, Pennsylvania, United States

Countries

United States

Central Contacts

Emma Iacobucci

Role: CONTACT

Emma.Iacobucci@Pennmedicine.upenn.edu

215-662-9393

Facility Contacts

Vatinee Bunya, MD

Role: primary

Vatinee.bunya@pennmedicine.upenn.edu

215-662-9393

Other Identifiers

827285

Identifier Type: -

Identifier Source: org_study_id