Penn SICCA Follow-up Study

Dry Eye Clinical Trial

— PSFS  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05056012
• Other study ID #: 827285
• Status: Not yet recruiting
• Start date: July 2024
• Est. completion date: July 2026

Study information

• Verified date: May 2024
• Source: University of Pennsylvania
• Contact: Adrienne Saludades
• Phone: 215-662-8091
• Email: Adrienne.Saludades[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: July 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Sjogren's Syndrome

Locations

Country	Name	City	State
United States	Scheie Eye Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Serologic testing	Characterize the laboratory, including serologic (including autoantibodies), features of dry eye patients with or without Sjogren's syndrome.	2 years