NCT04493658

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2020

Completed
20 days until next milestone

First Posted

Study publicly available on registry

July 30, 2020

Completed
6 months until next milestone

Study Start

First participant enrolled

January 11, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 3, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 3, 2022

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

1.7 years

First QC Date

July 10, 2020

Last Update Submit

January 4, 2023

Conditions

Keratoconjunctivitis SiccaDry Eye SyndromesOcular Surface DiseaseSjogren's Syndrome

Keywords

dry eyekeratoconjunctivitis siccaocular surface diseasesjogrens syndrome

Outcome Measures

Primary Outcomes (11)

  • Mood Questionnaire

    The "Mood Questionnaire" is a self-administered, 7-item questionnaire to measure the mood status. The score ranges from 7 to 28, higher score indicating better mood. The mean and median score in Sjogren's related dry eye group will be compared to non-Sjogren's and normal control group statistically.

    Once per patient on the day of enrollment.

  • Center for Epidemiologic Studies Depression Scale (CES-D)

    The "Center for Epidemiologic Studies Depression Scale (CES-D)" is a self-administered, 20-item questionnaire to measure the mood and behavioral status. The score ranges between 0 to 60, higher scores indicate the presence of worse symptomology. The mean and median score in Sjogren's related dry eye group will be compared to non-Sjogren's and normal control group statistically.

    Once per patient on the day of enrollment.

  • Ocular Surface Disease Index (OSDI)

    The "Ocular Surface Disease Index (OSDI)" is a self-administered, 12-item questionnaire to measure the dry eye status.). The score ranges from 0 to 100, higher scores indicate the presence of worse symptomology. The mean and median score in Sjogren's related dry eye group will be compared to non-Sjogren's and normal control group statistically.

    Once per patient on the day of enrollment.

  • Visual Functioning Questionnaire-25 (VFQ-25)

    The "Visual Functioning Questionnaire-25 (VFQ-25)" is a self-administered, 25-item questionnaire to measure the vision related quality of life. The score ranges from 0 to 100, higher scores indicate better functioning. The mean and median score in Sjogren's related dry eye group will be compared to non-Sjogren's and normal control group statistically.

    Once per patient on the day of enrollment.

  • Impact of Dry Eye on Everyday Life (IDEEL)

    The "Impact of Dry Eye on Everyday Life (IDEEL)" is a self-administered, 57-item questionnaire to measure the impact of dry eye and dry eye treatments on quality of life. Scores for each dimension ranges from 0 to 100. Higher scores indicate less impact on daily activities/work/emotions; greater bother due to symptoms; greater satisfaction with treatment effectiveness; and less treatment-related bother or inconvenience. The mean and median score in Sjogren's related dry eye group will be compared to non-Sjogren's and normal control group statistically.

    Once per patient on the day of enrollment.

  • Visual Tasking Questionnaire (VTQ)

    The "Visual Tasking Questionnaire (VTQ)" is a self-administered, 14-item questionnaire to measure the visual functioning status. The composite score for a visual function is defined as the mean response for the items listed for that visual function. The mean and median score in Sjogren's related dry eye group will be compared to non-Sjogren's and normal control group statistically.

    Once per patient on the day of enrollment.

  • 36 Item Short Form Survey (SF-36)

    The "36 Item Short Form Survey (SF-36)" is a self-administered, 36-item questionnaire to measure the self-perceived health status. Scoring ranges from 0 to 100. The lower score indicates higher disability. The mean and median score in Sjogren's related dry eye group will be compared to non-Sjogren's and normal control group statistically.

    Once per patient on the day of enrollment.

  • Profile of Fatigue and Discomfort (PROFAD)

    The "Profile of Fatigue and Discomfort (PROFAD)" is a self-administered, 19-item questionnaire to measure the fatigue status. Scoring ranges from 0 to 28, with higher scores indicating worse functioning. The mean and median score in Sjogren's related dry eye group will be compared to non-Sjogren's and normal control group statistically.

    Once per patient on the day of enrollment.

  • EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)

    The "EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)" is a self-administered, 3-item questionnaire to measure the dryness, fatigue, and pain status. Scores range from 0 to 30, with higher scores indicating higher severity. The mean and median score in Sjogren's related dry eye group will be compared to non-Sjogren's and normal control group statistically.

    Once per patient on the day of enrollment.

  • Visual Fatigue Analogue Scale (VFAS)

    The "Visual Fatigue Analogue Scale (VFAS)" is a self-administered, single scale indication, measuring visual fatigue. The score ranges from 0 to 100, with higher score indicating worse fatigue. The mean and median score in Sjogren's related dry eye group will be compared to non-Sjogren's and normal control group statistically.

    Once per patient on the day of enrollment.

  • Visual Dryness Analogue Scale (VDAS)

    The "Visual Dryness Analogue Scale (VDAS)" is a self-administered, single scale indication, measuring eye dryness. The score ranges from 0 to 100, with higher score indicating worse dryness. The mean and median score in Sjogren's related dry eye group will be compared to non-Sjogren's and normal control group statistically.

    Once per patient on the day of enrollment.

Secondary Outcomes (2)

  • Impression Cytology of Ocular Surface

    Once per patient on the day of enrollment.

  • Inflammatory markers of tear film

    Once per patient on the day of enrollment.

Study Arms (3)

Sjogrens syndrome dry eye

Patients with a previous diagnosis of dry eye made by an eye care specialist and a diagnosis of Sjogren's syndrome made according to the 2016 revised criteria

Diagnostic Test: QuestionnairesDiagnostic Test: Tear fluid samplingDiagnostic Test: Impression Cytology

Non-Sjogrens syndrome dry eye

Patients with a previous diagnosis of dry eye made by an eye care specialist and no diagnosis of Sjogren's syndrome based on 2016 revised criteria.

Diagnostic Test: QuestionnairesDiagnostic Test: Tear fluid samplingDiagnostic Test: Impression Cytology

Control

Normal individuals with no previous diagnosis of dry eye or Sjogren's syndrome

Diagnostic Test: QuestionnairesDiagnostic Test: Tear fluid samplingDiagnostic Test: Impression Cytology

Interventions

QuestionnairesDIAGNOSTIC_TEST

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

ControlNon-Sjogrens syndrome dry eyeSjogrens syndrome dry eye
Tear fluid samplingDIAGNOSTIC_TEST

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

ControlNon-Sjogrens syndrome dry eyeSjogrens syndrome dry eye
Impression CytologyDIAGNOSTIC_TEST

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

ControlNon-Sjogrens syndrome dry eyeSjogrens syndrome dry eye

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult individuals, both male and female, who have been diagnosed with dry eye, as well as adult normal controls will be included.

You may qualify if:

  • Capacity to give informed consent
  • Self-reported literacy
  • Best corrected visual acuity at distance 20/40 in each eye
  • Signed Institutional Review Board (IRB) approved consent agreeing to terms of the study
  • Differentiation of SS-related versus non-SS dry eye will be made according to the 2016 revised SS classification criteria.
  • The classification criteria are based on the weighted sum of the below 5 items:
  • SS laboratory findings
  • Anti-Sjogren's Antibody A (SSA) antibody positivity
  • Focal lymphocytic sialadenitis with a focus score ≥ 1 foci/mm2
  • each scoring=3
  • SS clinical findings
  • Abnormal ocular staining score ≥ 5 (or van Bijsterveld score ≥ 4) in one eye
  • Schirmer test ≤ 5 mm/5 min (without anesthesia) in one eye
  • Unstimulated salivary flow rate ≤ 0.1 mL/min
  • each scoring=1
  • +1 more criteria

You may not qualify if:

  • Age less than 18 years
  • Known diagnoses of: Hepatitis C infection, HIV infection, Sarcoidosis, Amyloidosis, Graft Versus Host Disease (GVHD), Cicatrizing conjunctivitis (ie. from trachoma, Stevens-Johnsons Syndrome (SJS), pemphigoid, drug induced pseudo-pemphigoid, or chemical burns, other severe ocular surface diseases such as atopic keratoconjunctivitis
  • Physical or mental issues, illiteracy, language problems which might possibly interfere with reading ability or other condition that would preclude successful participation in this study
  • Contact lens wear within 10 days of enrollment
  • Any intraocular surgery (including cataract surgery) within the last 3 months
  • Any minor ocular surgery including tear duct cauterization or plugs, within the last 30 days
  • Any history of corneal surgery or cosmetic lid surgery in the past 12 months
  • Best corrected vision worse than 20/40
  • Pregnant or nursing
  • Artificial tear use within 24 hours of study visit
  • History of taking or current use of topical prescription eye drops (including, cyclosporine and steroids as well as any glaucoma eye drops).
  • Patients who are willing to discontinue their treatment for at least a period of 30 days can be placed on a "wash-out period" as per the discretion of the investigator and patient safety, and be eligible at the end of this period, given all other criteria have been met. Otherwise, patients on these medications will be excluded.
  • Any person treated with glaucoma drops in the past (more than 30 days ago) or who had glaucoma surgery (more than 12 months ago) can be included.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilmer Eye Insitute, Johns Hopkins School of Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (2)

  • Akpek EK, Wu HY, Karakus S, Zhang Q, Masli S. Differential Diagnosis of Sjogren Versus Non-Sjogren Dry Eye Through Tear Film Biomarkers. Cornea. 2020 Aug;39(8):991-997. doi: 10.1097/ICO.0000000000002299.

    PMID: 32195754BACKGROUND

  • Shiboski CH, Shiboski SC, Seror R, Criswell LA, Labetoulle M, Lietman TM, Rasmussen A, Scofield H, Vitali C, Bowman SJ, Mariette X; International Sjogren's Syndrome Criteria Working Group. 2016 American College of Rheumatology/European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome: A Consensus and Data-Driven Methodology Involving Three International Patient Cohorts. Arthritis Rheumatol. 2017 Jan;69(1):35-45. doi: 10.1002/art.39859. Epub 2016 Oct 26.

    PMID: 27785888BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Tear fluid samples and impression cytology

MeSH Terms

Conditions

Keratoconjunctivitis SiccaDry Eye SyndromesSjogren's Syndrome

Condition Hierarchy (Ancestors)

KeratoconjunctivitisConjunctivitisConjunctival DiseasesEye DiseasesKeratitisCorneal DiseasesLacrimal Apparatus DiseasesArthritis, RheumatoidArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesXerostomiaSalivary Gland DiseasesMouth DiseasesStomatognathic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Esen Akpek, MD

    Johns Hopkins Univeristy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 10, 2020

First Posted

July 30, 2020

Study Start

January 11, 2021

Primary Completion

October 3, 2022

Study Completion

October 3, 2022

Last Updated

January 5, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)