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Follow-up study of people with dry eye and Sjögren's syndrome

Follows people from an earlier study who have dry eye, with or without Sjögren's syndrome.

Plain-language title generated from the registry record
Registry title: Penn SICCA Follow-up Study

Key facts

Where
Philadelphia, United StatesSee the site

Where in United States

  • Scheie Eye InstitutePhiladelphia, United StatesNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
University of Pennsylvania
Trial code
NCT05056012
Record updated
2 March 2026
Original description
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.Read full original descriptionShow less

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.

Inclusion: 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.

Exclusion: Did not previously participate in SICCA study at Penn; Under the age of 18 years.

ClinicalTrials.gov NCT05056012