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 range18 Years
SexALL
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.
✓. 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.
What they're measuring
1
The proportion of patients with Sjögren's dry eye who demonstrate impaired corneal sensitivity
✕. 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.