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

Completed

• Conditions: Sjögren Syndrome; Dry Eye

• Registration Number: NCT06411132
• Lead Sponsor: Dompé Farmaceutici S.p.A

Brief 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 OPAS questionnaire results.

Detailed Description

This clinical study has been designed to evaluate the proportion of patients with confirmed Sjögren's dry eye who present with neurosensory abnormalities via demonstration of increased ocular pain and/or a decrease in corneal sensitivity.

A multicenter design allows for a greater diversity of patient population with Sjögren's dry eye.

The number of sites allows for quick enrollment and expedited results that will help physicians understand the corneal sensitivity levels in the population of patients with Sjögren's dry eye.

This study design is minimally invasive and may be completed in a single visit provided all qualification criteria are met. This design reduces the time commitment from patients, thereby reducing barriers for enrollment and participation.

Study Timeline

• Study First Submitted: 2024-05-08
• Study First Submitted QC: 2024-05-08
• Study Start: 2024-05-09
• Study First Posted: 2024-05-13
• Primary Completion: 2025-01-10
• Study Completion: 2025-01-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

1. Patient must be ≥18 years of age at time of screening.
2. Patient must have had a 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. Patient must have had a 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 may be included in the study. The patient and/or his/her legal representative must read, sign, and date the IRB-approved informed consent document before any study-related procedures are performed.
6. Patients must 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, provide written informed consent, and 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 may affect corneal sensitivity or tear production.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of patients with Sjögren's dry eye who demonstrate impaired corneal sensitivity	Visit 1 (Day 1)	The number and proportion of patients with Sjögren's dry eye who have decreased corneal sensitivity, as determined by Cochet-Bonnet esthesiometer, will be shown with the 95% CI (Wilson method).

Secondary Outcome Measures

Name	Time	Method
Corneal sensitivity, as measured via Cochet-Bonnet esthesiometer.	Visit 1 (Day 1)	Summary statistics for continuous and categorical variables will be used to assess the secondary endpoints. Any statistical testing will be descriptive in nature.
Tear secretion, as measured via Schirmer I test.	Visit 1 (Day 1)	Summary statistics for continuous and categorical variables will be used to assess the secondary endpoints. Any statistical testing will be descriptive in nature.
OPAS questionnaire results.	Visit 1 (Day 1)	Summary statistics for continuous and categorical variables will be used to assess the secondary endpoints. Any statistical testing will be descriptive in nature.

Trial Locations

Locations (15)

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

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