Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögren's Dry Eye (NCT06411132) | Clinical Trial Compass
TerminatedNot Applicable
Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögren's Dry Eye
Stopped: The analyses presented are based on a database lock date of 05 March 2025.The study was prematurely interrupted by Dompé following a review of the database, which determined that an acceptable no. of patients was reached to meet the trial objectives.
United States103 participantsStarted 2024-05-09
Plain-language summary
Primary Objective
\- To assess the proportion of patients with Sjögren's dry eye who demonstrate impaired corneal sensitivity.
Secondary Objectives
* To assess corneal sensitivity via Cochet-Bonnet esthesiometer.
* To assess tear secretion via Schirmer I test.
* To assess Ocular Pain Assessment Survey (OPAS) questionnaire results.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Patients ≥18 years of age at time of screening.
. Confirmed diagnosis of Sjögren's for a minimum of 3 months before enrollment, as determined by either serologic antibody testing (anti-SSA/anti-SSB) or biopsy of minor salivary glands.
. Confirmed diagnosis of dry eye for a minimum of 3 months before enrollment, as determined by signs and/or symptom assessment.
. Fluorescein corneal staining with a cobalt blue light must show punctate corneal fluorescein staining or staining consistent with corneal epithelial damage equivalent or greater than 1 on the NEI scale by dry eye at enrollment.
. Only patients who satisfy all informed consent requirements were included in the study. The patient and/or his/her legal representative should read, sign, and date the IRB-approved informed consent document before any study-related procedures were performed.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The proportion of patients with Sjögren's dry eye who demonstrate impaired corneal sensitivity
. Patients should have the ability and willingness to comply with study procedures.
Exclusion criteria
. Inability to speak and understand English sufficiently to understand the nature of the study, to provide written informed consent, and to allow the completion of all study assessments.
. Presence of active ocular infection (bacterial, viral, protozoal) in either eye, as deemed by the Investigator or confirmed culture.
. Previous use of OXERVATE® ophthalmic solution.
. Presence of gross epithelial defect, including a defect with stromal involvement.
. Any concurrent medical condition that, in the judgment of the Investigator, might interfere with the conduct of the study or confound the interpretation of the study results.
. Any eyelid abnormalities, such as lagophthalmos, entropion, ectropion, or other neuromuscular abnormalities, that result in prolonged exposure of the corneal surface.
. Concurrent epithelial corneal disease or dystrophy unrelated to dry eye, such as anterior basement membrane dystrophy.
. Inability to remove contact lenses for a minimum of 3 hours before corneal sensitivity testing.