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

NCT06411132

TerminatedN/A

Sponsor: Dompé Farmaceutici S.p.A

Conditions: Sjögren Syndrome, Dry Eye

Interventions: observational study

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria
Inclusion Criteria:

1. Patients ≥18 years of age at time of screening.
2. 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.
3. Confirmed diagnosis of dry eye for a minimum of 3 months before enrollment, as determined by signs and/or symptom assessment.
4. 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.
5. 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.
6. Patients should have the ability and willingness to comply with study procedures.

Exclusion Criteria:

1. 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.
2. Presence of active ocular infection (bacterial, viral, protozoal) in either eye, as deemed by the Investigator or confirmed culture.
3. Previous use of OXERVATE® ophthalmic solution.
4. Presence of gross epithelial defect, including a defect with stromal involvement.
5. 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.
6. Any eyelid abnormalities, such as lagophthalmos, entropion, ectropion, or other neuromuscular abnormalities, that result in prolonged exposure of the corneal surface.
7. Concurrent epithelial corneal disease or dystrophy unrelated to dry eye, such as anterior basement membrane dystrophy.
8. Inability to remove contact lenses for a minimum of 3 hours before corneal sensitivity testing.
9. Inability to discontinue use of all topical ophthalmic treatments for a minimum of 3 hours before corneal sensitivity testing.
10. 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.
11. 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.
12. History of corneal stromal surgery, including anterior lamellar keratoplasty, deep anterior lamellar keratoplasty, and penetrating keratoplasty.
13. Current participation in another clinical study that might affect corneal sensitivity or tear production.
Locations (15)
  • Bakersfield, California, United States
  • Aurora, Colorado, United States
  • Jacksonville, Florida, United States
  • Miami, Florida, United States
  • Baltimore, Maryland, United States
  • Boston, Massachusetts, United States
  • Woodbury, Minnesota, United States
  • Dover, New Jersey, United States
  • New York, New York, United States
  • Raleigh, North Carolina, United States
  • Shelby, North Carolina, United States
  • Wilmington, North Carolina, United States
  • Philadelphia, Pennsylvania, United States
  • Nashville, Tennessee, United States
  • Seattle, Washington, United States