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Differential Diagnosis of Sjögren's Versus Non-Sjögren's Dry Eye

NCT04493658 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 92

Last updated 2023-01-05

No results posted yet for this study

Summary

To investigate and compare the burden of dry eye in Sjögren's syndrome dry eye vs non-Sjögren's syndrome dry eye, as well as investigate the diagnostic potential of tear film mucins and various inflammatory cytokines evaluated by tear fluid analysis and impression cytology.

Conditions

  • Keratoconjunctivitis Sicca
  • Dry Eye Syndromes
  • Ocular Surface Disease
  • Sjogren's Syndrome

Interventions

DIAGNOSTIC_TEST

Questionnaires

Cognitive ability questionnaires, dry eye symptom questionnaires (Ocular Surface Disease Index, Impact of Dry Eye in Everyday Life, Visual Function Questionnaire-25, Eye Dryness Visual Analog Scale, Visual Fatigue Visual Analog Scale, Visual Tasking Questionnaire, Short Form Survey-36, Profile of Fatigue and Discomfort, European League Against Rheumatism Sjögren's Syndrome Patient Reported Index) will be completed by the subjects

DIAGNOSTIC_TEST

Tear fluid sampling

Using microcapillary tubes, 1 microliter of tear fluid will be collected in both eyes of each subject.

DIAGNOSTIC_TEST

Impression Cytology

Under topical anesthesia, impression cytology sampling will be performed in the temporal bulbar conjunctiva of both eyes of each subject.

Sponsors & Collaborators

Principal Investigators

  • Esen Akpek, MD · Johns Hopkins Univeristy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-11
Primary Completion
2022-10-03
Completion
2022-10-03

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04493658 on ClinicalTrials.gov