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Sjögren's dry eye study probes corneal nerve damage

NCT ID NCT06411132

Knowledge-focused Sponsor: Dompé Farmaceutici S.p.A Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aimed to find out how many people with Sjögren's dry eye have reduced feeling in their cornea (the clear front part of the eye). Researchers measured corneal sensitivity, tear production, and pain in 103 adults with confirmed Sjögren's syndrome and dry eye. The study was terminated early, so results may be limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

103 people

The number who actually took part.

Started

May 2024

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patients ≥18 years of age at time of screening. 2. 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. 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 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. 6. Patients should 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, to provide written informed consent, and to 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 might affect corneal sensitivity or tear production.

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Conditions

The condition(s) this trial relates to.

dry eye syndrome Sjogren syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dry eye Sjögren syndrome

Contacts and locations

Locations

  • Bowden Eye

    Jacksonville, Florida, 32256, United States

  • Eye Associates of North Jersey

    Dover, New Jersey, 07801, United States

  • Focus Eye Care

    Wilmington, North Carolina, 28405, United States

  • Johns Hopkins

    Baltimore, Maryland, 21287, United States

  • Minnesota Eye Consultants

    Woodbury, Minnesota, 55125, United States

  • Periman Eye Institute

    Seattle, Washington, 98119, United States

  • Toyos Clinic

    Nashville, Tennessee, 37215, United States

  • Triangle Eye Consultants

    Raleigh, North Carolina, 27617, United States

  • Tufts University School of Medicine

    Boston, Massachusetts, 02111, United States

  • University of Colorado

    Aurora, Colorado, 80045, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Vita Eye Clinic

    Shelby, North Carolina, 28150, United States

  • Weil Cornell Medicine

    New York, New York, 10021, United States

  • West Coast Eye Institute

    Bakersfield, California, 11901, United States

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