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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dry Eye; Sjögren Syndrome
• Intervention / Treatment: Other: observational study

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 Type: Observational
• Enrollment (Estimated): 182

Contacts and Locations

• Study Contact: Name: Marta Sacchetti, MD, PhD; Phone Number: +39 02 583831; Email: clinical.trials@dompe.com
• Study Contact Backup: Name: Flavio P. Mantelli, MD, PhD; Phone Number: +39 02 583831; Email: clinical.trials@dompe.com

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 11901
      • Recruiting
      • West Coast Eye Institute
      • Contact: Sandeep Walia, MD
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado
      • Contact: Kaleb Abbott, OD
  • Florida
    • Jacksonville, Florida, United States, 32256
      • Recruiting
      • Bowden Eye
      • Contact: Jerry Robben, OD
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Contact: Alfonso Sabater, MD
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Recruiting
      • Tufts University School of Medicine
      • Contact: Pedram Hamrah, MD
  • Minnesota
    • Woodbury, Minnesota, United States, 55125
      • Recruiting
      • Minnesota Eye Consultants
      • Contact: Mark Buboltz, OD
  • New Jersey
    • Dover, New Jersey, United States, 07801
      • Recruiting
      • Eye Associates of North Jersey
      • Contact: Eric Mann, MD
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Weil Cornell Medicine
      • Contact: Christopher Starr, MD
  • North Carolina
    • Raleigh, North Carolina, United States, 27617
      • Recruiting
      • Triangle Eye Consultants
      • Contact: Preeya Gupta, MD
    • Shelby, North Carolina, United States, 28150
      • Recruiting
      • Vita Eye Clinic
      • Contact: Patrick Vollmer, OD
    • Wilmington, North Carolina, United States, 28405
      • Recruiting
      • Focus Eye Care
      • Contact: Crystal Brimer, OD
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • University of Pennsylvania
      • Contact: Mina Massaro, MD
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Recruiting
      • Toyos Clinic
      • Contact: Melissa Toyos, MD
  • Washington
    • Seattle, Washington, United States, 98119
      • Recruiting
      • Periman Eye Institute
      • Contact: Laura Periman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Collaborators and Investigators

• Sponsor: Dompé Farmaceutici S.p.A
• Investigators: Study Director: Scott Hauswirth, OD, Dompé Farmaceutici SpA

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2024
• Primary Completion (Estimated): February 3, 2025
• Study Completion (Estimated): February 3, 2025

Study Registration Dates

• First Submitted: May 8, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Observational; Dry Eye; Sjögren's dry eye; Multinational
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Eye Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Stomatognathic Diseases; Mouth Diseases; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Arthritis, Rheumatoid; Xerostomia; Salivary Gland Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Sjogren's Syndrome
• Other Study ID Numbers: DEV0123

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No