Clinical trial NCT06411132: Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögren's Dry Eye
Official title: A Multicenter, Observational Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögren's Dry Eye
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sjögren Syndrome
Dry Eye
Keywords: Observational
Dry Eye
Sjögren's dry eye
Multinational
Lead sponsor: Dompé Farmaceutici S.p.A
Sponsor class: INDUSTRY
First posted: 2024-05-13
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The screened population will consist of all patients who sign the ICF and are assigned a patient identification number. The full analysis set will include 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, secondary endpoints are provided on this population.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of patients with Sjögren's dry eye who demonstrate impaired corneal sensitivity
timeFrame: Visit 1 (Day 1)
Secondary outcomes:
measure: Corneal sensitivity, as measured via Cochet-Bonnet esthesiometer.
timeFrame: Visit 1 (Day 1)
measure: Tear secretion, as measured via Schirmer I test.
timeFrame: Visit 1 (Day 1)
measure: OPAS questionnaire results.
timeFrame: Visit 1 (Day 1)
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: West Coast Eye Institute
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Jacksonville
country: United States
facility: Bowden Eye
state: Florida
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Boston
country: United States
facility: Tufts University School of Medicine
state: Massachusetts
city: Woodbury
country: United States
facility: Minnesota Eye Consultants
state: Minnesota
city: Dover
country: United States
facility: Eye Associates of North Jersey
state: New Jersey
city: New York
country: United States
facility: Weil Cornell Medicine
state: New York
city: Raleigh
country: United States
facility: Triangle Eye Consultants
state: North Carolina
city: Shelby
country: United States
facility: Vita Eye Clinic
state: North Carolina
city: Wilmington
country: United States
facility: Focus Eye Care
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Toyos Clinic
state: Tennessee
city: Seattle
country: United States
facility: Periman Eye Institute
state: Washington
Study officials:
affiliation: Dompé Farmaceutici SpA
name: Scott Hauswirth, OD
role: STUDY_DIRECTOR
References: