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

NCT ID: NCT06411132

Last Updated: 2025-11-20

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 103 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-09
• Study Completion Date: 2025-01-10

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 Ocular Pain Assessment Survey (OPAS) questionnaire results.

Detailed Description

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

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

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

This study design was minimally invasive and might be completed in a single visit provided all qualification criteria were met.

This design reduced the time commitment from patients, thereby reducing barriers for enrollment and participation.

Only one eye (study eye) was analyzed for endpoints; if both eyes qualified for the study, the eye with the worse staining (per National Eye Institute [NEI] scale) was the study eye. If staining was equal between eyes, the right eye was the study eye.

Please note that no safety monitoring was captured, as this was an observational and descriptive study, and no study drug was administered. All testing and procedures conducted in this study were performed consistent with clinical practice standards and should not pose any additional risk to patients.

Conditions

Sjögren Syndrome; Dry Eye

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Full Analysis set

The full analysis set includes all patients who meet all the inclusion criteria and none of the exclusion criteria at the end of the screening procedure. All the analyses on the primary and secondary endpoints will be provided on this population. The screened population consists of all patients who sign the ICF and are assigned a patient identification number.

Please note that the sample size may vary depending on feasibility.

observational study

Intervention Type: OTHER

observational study

Interventions

observational study

observational study

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dompé Farmaceutici S.p.A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Scott Hauswirth, OD

Role: STUDY_DIRECTOR

Dompé Farmaceutici SpA

Locations

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

Countries

United States

Other Identifiers

DEV0123

Identifier Type: -

Identifier Source: org_study_id