Keratoconjunctivitis SiccaNCT04493658
Differential Diagnosis of Sjögren's Versus Non-Sjögren's Dry Eye
An observational study of Keratoconjunctivitis Sicca and Dry Eye Syndromes, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoconjunctivitis Sicca, Dry Eye Syndromes, Ocular Surface Disease
- What is being tested?
- Questionnaires, Tear fluid sampling and Impression Cytology
- How many people
- 92 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2021to 3 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult individuals, both male and female, who have been diagnosed with dry eye, as well as adult normal controls will be included.
Who may be able to join
- 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
- Additional inclusion criteria for the dry eye group (both SS- and non-SS) will include a previous diagnosis of dry eye made by an eye care specialist.
- Differentiation of SS-related versus non-SS dry eye will be made according to the 2016 revised SS classification criteria.
Show all 18Show fewer
- 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
- Individuals who have a total score ≥ 4 for the items above, meet the criteria for primary SS. In other words, for final classification, an individual should have at least one laboratory and one clinical finding.
- Additional inclusion criteria for control subjects will include no previous history of dry eye diagnosis, and no known history of autoimmune disease, verified using a review of systems and past medical history form.
Who cannot join
- 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
Show all 14Show fewer
- 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.
- Additional exclusion criteria for control subjects will include previous history of dry eye diagnosis, or history of any known autoimmune, inflammatory or rheumatologic disease including but not limited to Sjögren's syndrome, rheumatoid arthritis, Lupus, mixed connective tissue disease, scleroderma. Also the above exclusion criteria apply to control subjects.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wilmer Eye Insitute, Johns Hopkins School of Medicine
Baltimore, Maryland, 21287
About this study
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.
Read the detailed description
Dry eye is a prevalent ocular disorder worldwide and recognized as one of the most frequent reasons for seeking eye care. Whether locally or systemically initiated, inflammation plays a key role in the pathogenesis of dry eye. Approximately half of the patients with clinically significant dry eye have an underlying systemic inflammatory or autoimmune disease. One serious disease that causes significant dry eye is Sjögren's syndrome (SS). SS is an autoimmune disorder characterized by immune-mediated destruction of the salivary and lacrimal glands, with subsequent development of sicca symptoms. It is one of the most common autoimmune diseases in adults, affecting 1% to 4% of the general population. Approximately 10% of patients with clinically significant dry eye have underlying SS. Currently, the diagnosis of SS among dry eye patients is delayed by about a decade, largely due to lack of awareness and also diversity of patient symptoms and signs, adding to the complexity of diagnosis. Importantly, patients with SS are at risk for many ocular and systemic complications including central nervous system and visceral organ involvement as well as lymphoma. In fact, SS is the autoimmune disease most frequently associated with lymphoma. Therefore, identifying the subset of dry eye patients with SS is relevant.
Diagnosis of SS remains challenging mainly due to the lack of definitive diagnostic tests. The presence of aqueous-deficient dry eye is an integral part of diagnostic criteria for SS. Arguably, the hallmark of SS-related dry eye is conjunctival vital dye staining related to loss or alteration of the ocular surface mucins. A healthy conjunctiva is essential for ocular surface health as conjunctival goblet cells are responsible for secretion of the large gel-forming mucin MUC5AC which plays an important role in maintenance of the tear film on the ocular surface. Reduction of MUC5AC levels in tears of patients with SS has been demonstrated in a single previous study. The investigators also found lower levels of tear MUC5AC, and higher levels of IL-6 an IL-8 in patients with SS-dry eye in comparison to non-SS dry eye and controls. In addition, the investigators found the conjunctival lissamine green staining has a role in differentiating SS versus non-SS dry eye, independently of the dry eye severity.
In addition, increased levels of cytokines such as interleukin (IL)-13, IL-21, and interferon-gamma (IFN-γ) in tears and conjunctiva have previously been shown to correlate with goblet cell loss in SS as well as non-SS-dry eye patients. In murine studies, IFN-γ and tumor necrosis factor alpha (TNF-α) were reported to inhibit MUC5AC secretion in goblet cells stimulated with a cholinergic agonist. Such inhibition correlated with the expression of inflammatory cytokines in the conjunctiva of a mouse model of SS and significantly reduced tear MUC5AC levels. Nevertheless, targeting tear and ocular surface mucins and the relationships to various cytokines in dry eye as a diagnostic or therapeutic area has yet to be extensively studied.
Furthermore, it is well known that patients with SS-related dry eye have much more significant visual complaints than ocular discomfort symptoms arguably due to high corneal punctate erosion scores and diminished corneal subbasal nerve plexus when compared with non-SS dry eye patients. Although the exact mechanism of this is not known, cytokine levels in the tear film might possibly be a contributing factor. Indeed, the worsening of the corneal staining after prolonged gazing, could possibly be attributable to lack of tear film mucin as the investigators demonstrated the correlation between the conjunctival lissamine green staining (a surrogate for goblet cell density which secrete the mucin).
Lastly, although the advent of targeted biological treatments and other factors has led to renewed interest in Sjögren's among rheumatologists and immunologists, its ocular manifestations and burden remain underappreciated. As an example, the most widely used Sjögren's disease activity tool, the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), does not include the extraglandular ocular manifestations of Sjögren's, such as corneal melt/perforation, uveitis, scleritis, retinal vasculitis, and optic neuritis. In addition, the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) only includes one item that addresses the severity of dryness, but this refers to overall dryness and not specifically ocular dryness. Most importantly, these tools do not include any visual symptoms related to dry eye, such as blurred vision and visual or ocular fatigue. The investigators' most recent study points to a significant toll that the ocular manifestations of Sjögren's can have on patients emotionally, physically, and financially, in fact much more pronounced than other manifestation.
- Being tested
- Questionnaires, Tear fluid sampling, Impression Cytology
- Keywords
- dry eye, keratoconjunctivitis sicca, ocular surface disease, sjogrens syndrome
- Medical subject headings
- Keratoconjunctivitis Sicca, Dry Eye Syndromes, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Tear fluid samplingDiagnostic test
Using microcapillary tubes, 1 microliter of tear fluid will be collected in both eyes of each subject.
Impression CytologyDiagnostic test
Under topical anesthesia, impression cytology sampling will be performed in the temporal bulbar conjunctiva of both eyes of each subject.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Questionnaires; Diagnostic Test: Tear fluid sampling; Diagnostic 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. Receives: Diagnostic Test: Questionnaires; Diagnostic Test: Tear fluid sampling; Diagnostic Test: Impression Cytology | |
| Control | Normal individuals with no previous diagnosis of dry eye or Sjogren's syndrome Receives: Diagnostic Test: Questionnaires; Diagnostic Test: Tear fluid sampling; Diagnostic Test: Impression Cytology |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Once per patient on the day of enrollment.
Secondary outcomes (2)
Impression Cytology of Ocular Surface
Impression cytology samples will be stained using Hematoxiline \& Eosin. Samples will be examined using a light microscope. Mean and median goblet cell counts per high power field in Sjogren's related dry eye group will be compared to non-Sjogren's and normal control group statistically.
Measured: Once per patient on the day of enrollment.
Inflammatory markers of tear film
Tear film MUC5AC levels will be assessed with enzyme-linked immunosorbent assay (ng/mL), and cytokines [CXCL9, CXCL11, CXCL13, IL-1, IL-2, IL-6, IL-8, IL-10, IL-12, IL-17, IFN-gamma, and TNF-alpha] (ng/mL) will be measured using a Luminex assay in a masked fashion. The mean and median level in Sjogren's related dry eye group will be compared to non-Sjogren's and normal control group statistically.
Measured: Once per patient on the day of enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start11 Jan 2021
- Primary completion3 Oct 2022
- Study completion3 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Keratoconjunctivitis SiccaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esen Akpek, MD, Principal investigator, Johns Hopkins Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493658
- Sponsor's protocol ID
- IRB00247104
- Status last verified
- Jan 2023
- First submitted
- 10 Jul 2020
- Last updated
- 5 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32195754Shiboski 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.
PubMed 27785888
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Diagnosis of Sjögren's Versus Non-Sjögren's Dry Eye
- ClinicalTrials.gov ID
- NCT04493658
- Acronym / sponsor ID
- IRB00247104
- Keywords
- dry eye, keratoconjunctivitis sicca, ocular surface disease, sjogrens syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 3 Oct 2022 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Dry eye is a prevalent ocular disorder worldwide and recognized as one of the most frequent reasons for seeking eye care. Whether locally or systemically initiated, inflammation plays a key role in the pathogenesis of dry eye. Approximately half of the patients with clinically significant dry eye have an underlying systemic inflammatory or autoimmune disease. One serious disease that causes significant dry eye is Sjögren's syndrome (SS). SS is an autoimmune disorder characterized by immune-mediated destruction of the salivary and lacrimal glands, with subsequent development of sicca symptoms. It is one of the most common autoimmune diseases in adults, affecting 1% to 4% of the general population. Approximately 10% of patients with clinically significant dry eye have underlying SS. Currently, the diagnosis of SS among dry eye patients is delayed by about a decade, largely due to lack of awareness and also diversity of patient symptoms and signs, adding to the complexity of diagnosis. Importantly, patients with SS are at risk for many ocular and systemic complications including central nervous system and visceral organ involvement as well as lymphoma. In fact, SS is the autoimmune disease most frequently associated with lymphoma. Therefore, identifying the subset of dry eye patients with SS is relevant.
Diagnosis of SS remains challenging mainly due to the lack of definitive diagnostic tests. The presence of aqueous-deficient dry eye is an integral part of diagnostic criteria for SS. Arguably, the hallmark of SS-related dry eye is conjunctival vital dye staining related to loss or alteration of the ocular surface mucins. A healthy conjunctiva is essential for ocular surface health as conjunctival goblet cells are responsible for secretion of the large gel-forming mucin MUC5AC which plays an important role in maintenance of the tear film on the ocular surface. Reduction of MUC5AC levels in tears of patients with SS has been demonstrated in a single previous study. The investigators also found lower levels of tear MUC5AC, and higher levels of IL-6 an IL-8 in patients with SS-dry eye in comparison to non-SS dry eye and controls. In addition, the investigators found the conjunctival lissamine green staining has a role in differentiating SS versus non-SS dry eye, independently of the dry eye severity.
In addition, increased levels of cytokines such as interleukin (IL)-13, IL-21, and interferon-gamma (IFN-γ) in tears and conjunctiva have previously been shown to correlate with goblet cell loss in SS as well as non-SS-dry eye patients. In murine studies, IFN-γ and tumor necrosis factor alpha (TNF-α) were reported to inhibit MUC5AC secretion in goblet cells stimulated with a cholinergic agonist. Such inhibition correlated with the expression of inflammatory cytokines in the conjunctiva of a mouse model of SS and significantly reduced tear MUC5AC levels. Nevertheless, targeting tear and ocular surface mucins and the relationships to various cytokines in dry eye as a diagnostic or therapeutic area has yet to be extensively studied.
Furthermore, it is well known that patients with SS-related dry eye have much more significant visual complaints than ocular discomfort symptoms arguably due to high corneal punctate erosion scores and diminished corneal subbasal nerve plexus when compared with non-SS dry eye patients. Although the exact mechanism of this is not known, cytokine levels in the tear film might possibly be a contributing factor. Indeed, the worsening of the corneal staining after prolonged gazing, could possibly be attributable to lack of tear film mucin as the investigators demonstrated the correlation between the conjunctival lissamine green staining (a surrogate for goblet cell density which secrete the mucin).
Lastly, although the advent of targeted biological treatments and other factors has led to renewed interest in Sjögren's among rheumatologists and immunologists, its ocular manifestations and burden remain underappreciated. As an example, the most widely used Sjögren's disease activity tool, the EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI), does not include the extraglandular ocular manifestations of Sjögren's, such as corneal melt/perforation, uveitis, scleritis, retinal vasculitis, and optic neuritis. In addition, the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) only includes one item that addresses the severity of dryness, but this refers to overall dryness and not specifically ocular dryness. Most importantly, these tools do not include any visual symptoms related to dry eye, such as blurred vision and visual or ocular fatigue. The investigators' most recent study points to a significant toll that the ocular manifestations of Sjögren's can have on patients emotionally, physically, and financially, in fact much more pronounced than other manifestation.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sjogrens syndrome dry eye | – | Diagnostic Test: Questionnaires, Diagnostic Test: Tear fluid sampling, Diagnostic Test: Impression CytologyPatients 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 |
| Non-Sjogrens syndrome dry eye | – | Diagnostic Test: Questionnaires, Diagnostic Test: Tear fluid sampling, Diagnostic Test: Impression CytologyPatients 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. |
| Control | – | Diagnostic Test: Questionnaires, Diagnostic Test: Tear fluid sampling, Diagnostic Test: Impression CytologyNormal individuals with no previous diagnosis of dry eye or Sjogren's syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult individuals, both male and female, who have been diagnosed with dry eye, as well as adult normal controls will be included.
Key inclusion criteria (18 listed)
- 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
- SS laboratory findings
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnairesCognitive 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 | Control, Non-Sjogrens syndrome dry eye, Sjogrens syndrome dry eye |
| Tear fluid samplingUsing microcapillary tubes, 1 microliter of tear fluid will be collected in both eyes of each subject. | Diagnostic test | Control, Non-Sjogrens syndrome dry eye, Sjogrens syndrome dry eye |
| Impression CytologyUnder topical anesthesia, impression cytology sampling will be performed in the temporal bulbar conjunctiva of both eyes of each subject. | Diagnostic test | Control, Non-Sjogrens syndrome dry eye, Sjogrens syndrome dry eye |
Primary outcome
Mood Questionnaire
Time frame: Once per patient on the day of enrollment.
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.
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Once per patient on the day of enrollment.
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.
Ocular Surface Disease Index (OSDI)
Time frame: Once per patient on the day of enrollment.
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.
Visual Functioning Questionnaire-25 (VFQ-25)
Time frame: Once per patient on the day of enrollment.
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.
Impact of Dry Eye on Everyday Life (IDEEL)
Time frame: Once per patient on the day of enrollment.
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.
Visual Tasking Questionnaire (VTQ)
Time frame: Once per patient on the day of enrollment.
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.
36 Item Short Form Survey (SF-36)
Time frame: Once per patient on the day of enrollment.
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.
Profile of Fatigue and Discomfort (PROFAD)
Time frame: Once per patient on the day of enrollment.
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.
EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
Time frame: Once per patient on the day of enrollment.
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.
Visual Fatigue Analogue Scale (VFAS)
Time frame: Once per patient on the day of enrollment.
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.
Visual Dryness Analogue Scale (VDAS)
Time frame: Once per patient on the day of enrollment.
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.
2 secondary outcomes
Impression Cytology of Ocular Surface
Time frame: Once per patient on the day of enrollment.
Inflammatory markers of tear film
Time frame: Once per patient on the day of enrollment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2023.
- Background: PubMed 32195754Akpek 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.
- Background: PubMed 27785888Shiboski 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esen Akpek, MD principal investigator
Johns Hopkins Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconjunctivitis Sicca and Dry Eye Syndromes, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mood Questionnaire (time frame: Once per patient on the day of enrollment.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04493658, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2023.