Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögren's Dry Eye

Stopped early

Conditions studied: Sjögren Syndrome, Dry Eye

In brief

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.

Key facts

Study ID

NCT06411132

Run by

Dompé Farmaceutici S.p.A

People needed

103

Starts

2024-05-09

Expected to finish

2025-01-10

Last updated by the study team

2025-11-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Inability to discontinue use of all topical ophthalmic treatments for a minimum of 3 hours before corneal sensitivity testing.
• Inability to suspend use of any neurostimulatory drugs or devices (including but not limited to nasal varenicline, iTear100, etc.) for treating dry eye or increasing tear film for 6 hours before testing.
• Ocular surgery (including but not limited to laser-assisted in situ keratomileusis, photorefractive keratectomy, tube shunt/trabeculectomy, or cataract surgery) within the last 6 months.
• History of corneal stromal surgery, including anterior lamellar keratoplasty, deep anterior lamellar keratoplasty, and penetrating keratoplasty.
• Current participation in another clinical study that might affect corneal sensitivity or tear production.

Where it is running

• West Coast Eye Institute — Bakersfield, California, United States
• University of Colorado — Aurora, Colorado, United States
• Bowden Eye — Jacksonville, Florida, United States
• University of Miami — Miami, Florida, United States
• Johns Hopkins — Baltimore, Maryland, United States
• Tufts University School of Medicine — Boston, Massachusetts, United States
• Minnesota Eye Consultants — Woodbury, Minnesota, United States
• Eye Associates of North Jersey — Dover, New Jersey, United States
• Weil Cornell Medicine — New York, New York, United States
• Triangle Eye Consultants — Raleigh, North Carolina, United States
• Vita Eye Clinic — Shelby, North Carolina, United States
• Focus Eye Care — Wilmington, North Carolina, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Toyos Clinic — Nashville, Tennessee, United States
• Periman Eye Institute — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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