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

NCT06411132 | Terminated

• 1 other identifier: DEV0123
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 15

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.

Conditions

Sjögren Syndrome; Dry Eye

Keywords

Observational; Dry Eye; Sjögren's dry eye; Multinational

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with Sjögren's dry eye who demonstrate impaired corneal sensitivity

  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).

  Visit 1 (Day 1)

Secondary Outcomes (3)

• Corneal sensitivity, as measured via Cochet-Bonnet esthesiometer.

  Visit 1 (Day 1)

• Tear secretion, as measured via Schirmer I test.

  Visit 1 (Day 1)

• OPAS questionnaire results.

  Visit 1 (Day 1)

Study Arms (1)

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.

Other: observational study

Interventions

observational study OTHER

observational study

Full Analysis set

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 182 patients were planned to be included in the study. Due to its early termination, a total of 114 patients were screened and 103 patients were included in the FAS. Eleven patients did not meet the inclusion and/or exclusion criteria. All patients (103 patients) completed the study. The screened population consisted of all patients who signed the ICF and were assigned a patient identification number. The full analysis set (FAS) included all patients who met all the inclusion criteria and none of the exclusion criteria at the end of the screening procedure. All the analyses on the primary, secondary endpoints are provided on this population (FAS).

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.

Sponsors & Collaborators

• Dompé Farmaceutici S.p.A: lead

Study Sites (15)

West Coast Eye Institute

Bakersfield, California, 11901, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

Bowden Eye

Jacksonville, Florida, 32256, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Johns Hopkins

Baltimore, Maryland, 21287, United States

Location

Tufts University School of Medicine

Boston, Massachusetts, 02111, United States

Location

Minnesota Eye Consultants

Woodbury, Minnesota, 55125, United States

Location

Eye Associates of North Jersey

Dover, New Jersey, 07801, United States

Location

Weil Cornell Medicine

New York, New York, 10021, United States

Location

Triangle Eye Consultants

Raleigh, North Carolina, 27617, United States

Location

Vita Eye Clinic

Shelby, North Carolina, 28150, United States

Location

Focus Eye Care

Wilmington, North Carolina, 28405, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Toyos Clinic

Nashville, Tennessee, 37215, United States

Location

Periman Eye Institute

Seattle, Washington, 98119, United States

Location

MeSH Terms

Conditions

Sjogren's Syndrome; Dry Eye Syndromes

Interventions

Observation

Condition Hierarchy (Ancestors)

Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Lacrimal Apparatus Diseases; Eye Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Scott Hauswirth, OD

  Dompé Farmaceutici SpA

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2024
• First Posted: May 13, 2024
• Study Start: May 9, 2024
• Primary Completion: January 10, 2025
• Study Completion: January 10, 2025
• Last Updated: November 20, 2025

Record last verified: 2025-03

Locations

US (15)