Dry Eye Clinical Trial
— GEMINAEOfficial title:
A Multicenter, Observational Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögren's Dry Eye
NCT number | NCT06411132 |
Other study ID # | DEV0123 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 15, 2024 |
Est. completion date | February 3, 2025 |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Dompé Farmaceutici S.p.A |
United States,
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) |
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