Sjogren's SyndromeIIRNCT06364657
Differences in Corneal Structure and Function in Patients With Sjogrens vs. Non-Sjogrens Dry Eye
An observational study of Sjogren's Syndrome and Dry Eye, run by Johns Hopkins University at 1 site in United States.
Trial summary
In this study the investigators plan to enroll three groups of patients: non-Sjogren's dry eye, Sjogren's dry eye and controls. The study has the following primary goals: 1. To determine whether dry eye is associated with reduced corneal sensation 2. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sjogren's Syndrome, Dry Eye, Neurotrophic Keratitis
- What is being tested?
- Eye Exam
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2024to 19 Dec 2024
- 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: Adults aged 18 years or older, with and without Sjogren's-related dry eye, and no previous diagnosis of dry eye or other ocular surface disease.
Who may be able to join
- Male or female aged 18 or older
- 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 the terms of the study For Sjogren's-related dry eye, the below inclusion criteria will be required
- a previous diagnosis of dry eye made by an eye care specialist
- a previous diagnosis of Sjogren's made according to the 2016 revised Sjogren's classification criteria
Who cannot join
- ● Age less than 18 years
- Physical or mental issues, illiteracy, or language problems that 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 (including LASIK/PRK) or cosmetic lid surgery in the past 12 months
Show all 23Show fewer
- Any history of glaucoma surgery (e.g., trabeculectomy or a tube shunt)
- Best corrected vision worse than 20/40
- Known history of severe ocular surface disease that might cause corneal haze and interfere with corneal staining score including but not limited to graft-versus-host disease, mucous membrane pemphigoid, atopic keratoconjunctivitis
- Presence of keratoconus
- Concurrent epithelial corneal disease or dystrophy (e.g., anterior basement membrane disease, pterygium, or scarring) that might affect the corneal staining score
- Previous use of OXERVATE® for neurotrophic keratitis
- Neurotrophic keratoconjunctivitis or corneal/conjunctival scarring (history of herpes simplex virus or varicella zoster virus keratitis)
- Any blepharitis eyelid procedures such as Intense Pulsed Light (IPL), low level light treatment therapy, LipiFlow®, or nasolacrimal duct probing in the last 30 days prior to the study visit
- Any acupuncture or physical therapy on the face or head within the past 3 months
- Current smoker (within the past year)
- Pregnant or nursing
- Artificial tear use within 2 hours of study visit
- Topical ophthalmic non-steroidal anti-inflammatory drug use 24 hours before the study visit
- History of taking or current use of topical glaucoma drops or neurostimulation drugs or devices for treating dry eye
- History or current intravitreal injections for macular degeneration
- History of continuous positive airway pressure usage in the past 3 months
- Any concurrent medical condition that in the judgment of the PI might interfere with the conduct of the study, confound the interpretation of the study results.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Hospital Wilmer Eye Institute
Baltimore, Maryland, 21287
About this study
Official title: Role of Neurotrophic Keratitis Versus Severity of Tear Film and Ocular Surface Parameters in Determining the Differences in Corneal Structure and Function in Patients With Sjogrens vs. Non-Sjogrens Dry Eye
In this study the investigators plan to enroll three groups of patients: non-Sjogren's dry eye, Sjogren's dry eye and controls. The study has the following primary goals:
- To determine whether dry eye is associated with reduced corneal sensation
- To determine whether reduced corneal sensation is due to the severity of the dry eye, the type of dry eye (primarily aqueous deficient versus primarily evaporative) or entirely related to the presence of Sjogren's
- To determine whether corneal sensation is associated with ocular or systemic pain symptoms Additionally, the study aims to compare the novel corneal esthesiometer measurements to confocal biomicroscopy findings in determining neurotrophic keratitis (NK) and assess correlations between corneal sensation.
- Conditions
- Sjogren's Syndrome, Dry Eye, Neurotrophic Keratitis
- Being tested
- Eye Exam
- Keywords
- Sjogren's Syndrome, Dry Eye, Neurotrophic Keratitis
- Medical subject headings
- Sjogren's Syndrome, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eye ExamDiagnostic test
- Symptom Questionnaires (OSDI, eye dryness VAS, visual fatigue VAS, eye discomfort VAS)
- Pain scale questionnaire [Wong-Baker Faces Pain Rating Scale and Ocular Pain Assessment Survey
- Best spectacle-corrected visual acuity (BSCVA) as measured by Snellen chart followed by Mars contrast sensitivity test.
- Corneal esthesiometer for measurement of corneal sensation
- Schirmer's without topical anesthesia
- Corneal epithelial thickness sand endothelial cell count using Anterior Segment Optical Coherence Tomography (AS-OCT)
- Staining for dry eye:
- Tear film break-up time (BUT) using fluorescein.
- Fluorescein staining (National Eye Institute (NEI) and Ocular staining score (OSS))
- Lissamine green staining (OSS and Oxford)
- Non-contact confocal biomicroscopy for morphology of the ocular surface
| Study group | Role | What they receive |
|---|---|---|
| Sjogren's related dry-eye | Patients over the age of 18 years with known dry eye with underlying Sjogren's syndrome. Includes a previous diagnosis of dry eye made by an eye care specialist and a previous diagnosis of Sjogren's made according to the 2016 revised Sjogren's classification criteria. Receives: Diagnostic Test: Eye Exam | |
| non-Sjogren's related dry-eye | Patients over the age of 18 years with known dry eye without underlying Sjogren's syndrome. Includes a previous diagnosis of dry eye made by an eye care specialist and a previous diagnosis of Sjogren's according to the 2016 revised Sjogren's classification criteria was definitively excluded Receives: Diagnostic Test: Eye Exam | |
| Control | Age-matched healthy controls with no known history of ocular surface diseases or dry eye or any underlying autoimmune disease Receives: Diagnostic Test: Eye Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal Epithelium health
Measuring epithelial staining score and epithelial thickness map using anterior segment Optical coherence tomography (OCT)
Measured: 1 Day
Corneal Nerve health
Corneal sensation using non-contact esthesiometer and corneal nerve density and morphology using non-contact confocal biomicroscopy
Measured: 1 Day
Secondary outcomes (2)
Correlations Between Corneal Staining Score
Correlations between corneal staining score with visual parameters, epithelial thickness map, corneal nerve density and morphology, and corneal sensation
Measured: 1 Day
Correlations Between Patient Symptoms
Correlations between the patient symptoms and above corneal findings using Ocular Surface Disease Index (OSDI), Visual Acuity Scale (VAS), and pain scale questionnaire
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start1 Jul 2024
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
Why it stopped: The study was prematurely closed to enrollment due to the principal investigator's departure from the institution (Johns Hopkins University).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjogren's SyndromeStudies 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
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Dompé, US, Inc.
- Responsible party
- Sponsor
- Investigators
- Esen K Akpek, MD, Principal investigator, Johns Hopkins Hospital Wilmer Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06364657
- Sponsor's protocol ID
- IRB00439625
- Acronym
- IIR
- Status last verified
- Jan 2025
- First submitted
- 4 Apr 2024
- Last updated
- 15 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Neurotrophic Keratitis Versus Severity of Tear Film and Ocular Surface Parameters in Determining the Differences in Corneal Structure and Function in Patients With Sjogrens vs. Non-Sjogrens Dry Eye
- ClinicalTrials.gov ID
- NCT06364657
- Acronym / sponsor ID
- IIR / IRB00439625
- Conditions
- Sjogren's Syndrome, Dry Eye, Neurotrophic Keratitis
- Keywords
- Sjogren's Syndrome, Dry Eye, Neurotrophic Keratitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was prematurely closed to enrollment due to the principal investigator's departure from the institution (Johns Hopkins University).
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Dompé, US, Inc.
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 15 Apr 2024 (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.
In this study the investigators plan to enroll three groups of patients: non-Sjogren's dry eye, Sjogren's dry eye and controls. The study has the following primary goals:
- To determine whether dry eye is associated with reduced corneal sensation
- To determine whether reduced corneal sensation is due to the severity of the dry eye, the type of dry eye (primarily aqueous deficient versus primarily evaporative) or entirely related to the presence of Sjogren's
- To determine whether corneal sensation is associated with ocular or systemic pain symptoms Additionally, the study aims to compare the novel corneal esthesiometer measurements to confocal biomicroscopy findings in determining neurotrophic keratitis (NK) and assess correlations between corneal sensation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sjogren's related dry-eye | – | Diagnostic Test: Eye ExamPatients over the age of 18 years with known dry eye with underlying Sjogren's syndrome. Includes a previous diagnosis of dry eye made by an eye care specialist and a previous diagnosis of Sjogren's made according to the 2016 revised Sjogren's classification criteria. |
| non-Sjogren's related dry-eye | – | Diagnostic Test: Eye ExamPatients over the age of 18 years with known dry eye without underlying Sjogren's syndrome. Includes a previous diagnosis of dry eye made by an eye care specialist and a previous diagnosis of Sjogren's according to the 2016 revised Sjogren's classification criteria was definitively excluded |
| Control | – | Diagnostic Test: Eye ExamAge-matched healthy controls with no known history of ocular surface diseases or dry eye or any underlying autoimmune disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults aged 18 years or older, with and without Sjogren's-related dry eye, and no previous diagnosis of dry eye or other ocular surface disease.
Key inclusion criteria (7 listed)
- Male or female aged 18 or older
- 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 the terms of the study For Sjogren's-related dry eye, the below inclusion criteria will be required
Key exclusion criteria (23 listed)
- ● Age less than 18 years
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 |
|---|---|---|
| Eye Exam* Symptom Questionnaires (OSDI, eye dryness VAS, visual fatigue VAS, eye discomfort VAS) * Pain scale questionnaire [Wong-Baker Faces Pain Rating Scale and Ocular Pain Assessment Survey * Best spectacle-corrected visual acuity (BSCVA) as measured by Snellen chart followed by Mars contrast sensitivity test. * Corneal esthesiometer for measurement of corneal sensation * Schirmer's without topical anesthesia * Corneal epithelial thickness sand endothelial cell count using Anterior Segment Optical Coherence Tomography (AS-OCT) * Staining for dry eye: * Tear film break-up time (BUT) using fluorescein. * Fluorescein staining (National Eye Institute (NEI) and Ocular staining score (OSS)) * Lissamine green staining (OSS and Oxford) * Non-contact confocal biomicroscopy for morphology of the ocular surface | Diagnostic test | Control, Sjogren's related dry-eye, non-Sjogren's related dry-eye |
Primary outcome
Corneal Epithelium health
Time frame: 1 Day
Measuring epithelial staining score and epithelial thickness map using anterior segment Optical coherence tomography (OCT)
Corneal Nerve health
Time frame: 1 Day
Corneal sensation using non-contact esthesiometer and corneal nerve density and morphology using non-contact confocal biomicroscopy
2 secondary outcomes
Correlations Between Corneal Staining Score
Time frame: 1 Day
Correlations Between Patient Symptoms
Time frame: 1 Day
Results and safety
The study was stopped early (reason given: The study was prematurely closed to enrollment due to the principal investigator's departure from the institution (Johns Hopkins University).). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- 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 K Akpek, MD principal investigator
Johns Hopkins Hospital Wilmer Eye Institute
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 Sjogren's Syndrome and Dry Eye, 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 7 inclusion and 23 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: stopped early, as of the sponsor's last update on 15 Jan 2025. 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 was stopped early (reason given: The study was prematurely closed to enrollment due to the principal investigator's departure from the institution (Johns Hopkins University).). Results are not available in the source record.
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?
Corneal Epithelium health (time frame: 1 Day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jan 2025.