Penn SICCA Follow-up Study

Not yet recruiting

• Conditions: Sjogren's Syndrome; Dry Eye

• Registration Number: NCT05056012
• Lead Sponsor: University of Pennsylvania

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-09-14
• Study First Submitted QC: 2021-09-14
• Study First Posted: 2021-09-24
• Status Verified: 2024-10
• Study Start: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. Previously participated in the SICCA study at Penn

2. Be 18 years or older

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Serologic testing	2 years	Characterize the laboratory, including serologic (including autoantibodies), features of dry eye patients with or without Sjogren's syndrome.
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.

Trial Locations

Locations (1)

Scheie Eye Institute; 🇺🇸 Philadelphia, Pennsylvania, United States