Sjögren SyndromeGEMINAENCT06411132
Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögren's Dry Eye
An observational study of Sjögren Syndrome and Dry Eye, run by Dompé Farmaceutici S.p.A at 15 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sjögren Syndrome, Dry Eye
- What is being tested?
- observational study
- How many people
- 103 participants
- Where
- 15 sitesUnited States
- Study dates
- 9 May 2024to 10 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
University of Colorado
Aurora, Colorado, 80045
West Coast Eye Institute
Bakersfield, California, 11901
Johns Hopkins
Baltimore, Maryland, 21287
Tufts University School of Medicine
Boston, Massachusetts, 02111
Eye Associates of North Jersey
Dover, New Jersey, 07801
Bowden Eye
Jacksonville, Florida, 32256
University of Miami
Miami, Florida, 33136
Toyos Clinic
Nashville, Tennessee, 37215
Weil Cornell Medicine
New York, New York, 10021
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Triangle Eye Consultants
Raleigh, North Carolina, 27617
Periman Eye Institute
Seattle, Washington, 98119
Vita Eye Clinic
Shelby, North Carolina, 28150
Focus Eye Care
Wilmington, North Carolina, 28405
Minnesota Eye Consultants
Woodbury, Minnesota, 55125
About this study
Official title: 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 Ocular Pain Assessment Survey (OPAS) questionnaire results.
Read the detailed description
This observational clinical study has been designed to evaluate the proportion of patients with confirmed Sjögren's dry eye who presented with neurosensory abnormalities via demonstration of increased ocular pain and/or a decrease in corneal sensitivity.
A multicenter design allowed for a greater diversity of patient population with Sjögren's dry eye.
The number of sites allowed for quick enrollment and expedited results that helped physicians understand the corneal sensitivity levels in the population of patients with Sjögren's dry eye.
This study design was minimally invasive and might be completed in a single visit provided all qualification criteria were met.
This design reduced the time commitment from patients, thereby reducing barriers for enrollment and participation.
Only one eye (study eye) was analyzed for endpoints; if both eyes qualified for the study, the eye with the worse staining (per National Eye Institute [NEI] scale) was the study eye. If staining was equal between eyes, the right eye was the study eye.
Please note that no safety monitoring was captured, as this was an observational and descriptive study, and no study drug was administered. All testing and procedures conducted in this study were performed consistent with clinical practice standards and should not pose any additional risk to patients.
- Conditions
- Sjögren Syndrome, Dry Eye
- Being tested
- observational study
- Keywords
- Observational, Dry Eye, Sjögren's dry eye, Multinational
- Medical subject headings
- Sjogren's Syndrome, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
observational study
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Visit 1 (Day 1)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Visit 1 (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2024
- Study start9 May 2024
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
Why it stopped: The analyses presented are based on a database lock date of 05 March 2025.The study was prematurely interrupted by Dompé following a review of the database, which determined that an acceptable no. of patients was reached to meet the trial objectives.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sjögren SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dompé Farmaceutici S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott Hauswirth, OD, Study director, Dompé Farmaceutici SpA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06411132
- Sponsor's protocol ID
- DEV0123
- Acronym
- GEMINAE
- Status last verified
- Mar 2025
- First submitted
- 8 May 2024
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Observational Study to Evaluate Corneal Neurosensory Abnormalities in Patients With Sjögren's Dry Eye
- ClinicalTrials.gov ID
- NCT06411132
- Acronym / sponsor ID
- GEMINAE / DEV0123
- Conditions
- Sjögren Syndrome, Dry Eye
- Keywords
- Observational, Dry Eye, Sjögren's dry eye, Multinational
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The analyses presented are based on a database lock date of 05 March 2025.The study was prematurely interrupted by Dompé following a review of the database, which determined that an acceptable no. of patients was reached to meet the trial objectives.
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Dompé Farmaceutici S.p.AIndustry (pharma, biotech, devices)
- Study start
- 9 May 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 13 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This observational clinical study has been designed to evaluate the proportion of patients with confirmed Sjögren's dry eye who presented with neurosensory abnormalities via demonstration of increased ocular pain and/or a decrease in corneal sensitivity.
A multicenter design allowed for a greater diversity of patient population with Sjögren's dry eye.
The number of sites allowed for quick enrollment and expedited results that helped physicians understand the corneal sensitivity levels in the population of patients with Sjögren's dry eye.
This study design was minimally invasive and might be completed in a single visit provided all qualification criteria were met.
This design reduced the time commitment from patients, thereby reducing barriers for enrollment and participation.
Only one eye (study eye) was analyzed for endpoints; if both eyes qualified for the study, the eye with the worse staining (per National Eye Institute [NEI] scale) was the study eye. If staining was equal between eyes, the right eye was the study eye.
Please note that no safety monitoring was captured, as this was an observational and descriptive study, and no study drug was administered. All testing and procedures conducted in this study were performed consistent with clinical practice standards and should not pose any additional risk to patients.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Full Analysis set | – | Other: observational studyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyobservational study | Other | Full Analysis set |
Primary outcome
The proportion of patients with Sjögren's dry eye who demonstrate impaired corneal sensitivity
Time frame: Visit 1 (Day 1)
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).
3 secondary outcomes
Corneal sensitivity, as measured via Cochet-Bonnet esthesiometer.
Time frame: Visit 1 (Day 1)
Tear secretion, as measured via Schirmer I test.
Time frame: Visit 1 (Day 1)
OPAS questionnaire results.
Time frame: Visit 1 (Day 1)
Results and safety
The study was stopped early (reason given: The analyses presented are based on a database lock date of 05 March 2025.The study was prematurely interrupted by Dompé following a review of the database, which determined that an acceptable no. of patients was reached to meet the trial objectives.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Hauswirth, OD study director
Dompé Farmaceutici SpA
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sjögren Syndrome and Dry Eye, run by Dompé Farmaceutici S.p.A at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The analyses presented are based on a database lock date of 05 March 2025.The study was prematurely interrupted by Dompé following a review of the database, which determined that an acceptable no. of patients was reached to meet the trial objectives.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with Sjögren's dry eye who demonstrate impaired corneal sensitivity (time frame: Visit 1 (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.