Penn SICCA Follow-up Study | NCT05056012

Studies
Penn SICCA Follow-up Study

NCT05056012

Sponsor

University of Pennsylvania

Status

Not yet recruiting

Last Update Posted

Mar 2, 2026Actual

Enrollment

220Estimated

Phase

Not provided

Conditions

Dry Eye
Sjogren's Syndrome

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2027Estimated

Primary Completion Date

Jan 2029Estimated

Completion Date

Jan 2029Estimated

First Submitted Date

Sep 14, 2021

First Submission Date that Met QC Criteria

Sep 14, 2021

First Posted Date

Sep 24, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 27, 2026

Last Update Posted Date

Mar 2, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vatinee Bunya, MD, Co-Director of Penn Dry Eye & Ocular Surface Center, University of PennsylvaniaPrincipal Investigator

Lead Sponsor

University of PennsylvaniaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

220Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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
Serologic testing	Characterize the laboratory, including serologic (including autoantibodies), features of dry eye patients with or without Sjogren's syndrome.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Previously participated in the SICCA study at Penn
Be 18 years or older

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Emma Iacobucci	Contact	215-662-9393		Emma.Iacobucci@Pennmedicine.upenn.edu

Overall Officials

Name	Affiliation	Role
Vatinee Bunya, MD	Scheie Eye Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Scheie Eye Institute		Philadelphia	Pennsylvania	19104	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015352	Dry Eye Syndromes
D012859	Sjogren's Syndrome

Ancestor Terms

ID	Term
D007766	Lacrimal Apparatus Diseases
D005128	Eye Diseases
D001172	Arthritis, Rheumatoid
D001168	Arthritis

Browse Leaves

Not provided

Browse Branches

Not provided

Description

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.