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

Dry Eye Clinical Trial

— GEMINAE  

Official title:

A Multicenter, Observational Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögren's Dry Eye

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06411132
• Other study ID #: DEV0123
• Status: Recruiting
• Start date: March 15, 2024
• Est. completion date: February 3, 2025

Study information

• Verified date: May 2024
• Source: Dompé Farmaceutici S.p.A
• Contact: Marta Sacchetti, MD, PhD
• Phone: +39 02 583831
• Email: clinical.trials[@]dompe.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: February 3, 2025
• Est. primary completion date: February 3, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Sjögren Syndrome
• Sjogren's Syndrome

Intervention

Other:
• observational study
observational study

Locations

Country	Name	City	State
United States	University of Colorado	Aurora	Colorado
United States	West Coast Eye Institute	Bakersfield	California
United States	Tufts University School of Medicine	Boston	Massachusetts
United States	Eye Associates of North Jersey	Dover	New Jersey
United States	Bowden Eye	Jacksonville	Florida
United States	University of Miami	Miami	Florida
United States	Toyos Clinic	Nashville	Tennessee
United States	Weil Cornell Medicine	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Triangle Eye Consultants	Raleigh	North Carolina
United States	Periman Eye Institute	Seattle	Washington
United States	Vita Eye Clinic	Shelby	North Carolina
United States	Focus Eye Care	Wilmington	North Carolina
United States	Minnesota Eye Consultants	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Dompé Farmaceutici S.p.A

Country where clinical trial is conducted

United States, 

Outcome

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