TRYPTYR eye drops for Sjögren's-related dry eye
Official title: Evaluating TRYPTYR as a Novel Therapy for Dry Eye in Patients With Sjögren's Syndrome
Run by Center For Sight · NCT07277257 · Data updated 2026-11-12
This study will test whether TRYPTYR (acoltremon 0.003% ophthalmic solution) improves symptoms and signs of dry eye in adults with Sjögren's syndrome.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | Center For Sight Academic / other |
| Locations | 1 site (Venice, Florida) |
| Status | Recruiting |
| Started | December 2, 2025 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | December 22, 2025 |
| Trial ID | NCT07277257 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older with a Sjögren's syndrome diagnosis within the past 2 years, who use or want artificial tears and meet the specified Schirmer (≥1 and <10 mm/5 min) and corneal fluorescein staining (tCFS 2–15 NEI scale) criteria are the intended participants.
✕Probably not a fit
People with recent ocular surgery, recent contact lens use, unstable or recently changed topical therapy, current use of certain topical steroids or nasal varenicline, or those who do not meet the Schirmer/tCFS ranges or the recent-diagnosis requirement are unlikely to be eligible or benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a Phase 4 interventional study testing topical TRYPTYR (acoltremon 0.003% ophthalmic solution) in adults with dry eye disease secondary to Sjögren's syndrome. Eligible participants must have a recent diagnosis (within 2 years), a requirement for or use of artificial tears, and objective signs within predefined Schirmer and corneal fluorescein staining ranges. The protocol excludes people with recent ocular surgery, recent contact lens use, unstable topical regimens, or certain topical medications. The study is being conducted at a single site in Venice, Florida, and will track changes in dry eye signs and symptoms over the treatment period.
Why it matters
Potential benefit: If successful, TRYPTYR could reduce discomfort and improve tear-related signs such as corneal staining and tear production in people with Sjögren's-related dry eye.
How similar studies have gone: Other topical anti-inflammatory and tear-modulating eye drops (for example cyclosporine and lifitegrast) have demonstrated benefits for dry eye, but acoltremon/TRYPTYR is a newer agent with limited published experience in Sjögren's-specific populations.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: Subjects must fulfill the following conditions to qualify for enrollment into the trial 1. Adults over 18 years old with a diagnosis of dry eye disease (DED) secondary to Sjögren's Syndrome within the past 2 years. 2. History of using or desiring artificial tears for DED symptoms within the past 2 months. 3. Unanesthetized Schirmer's Test (UA ST) score ≥1 and \< 10 mm/5 min and baseline total Corneal Fluorescein Staining (tCFS) score ≥2 and ≤ 15 (National Eye Institute, NEI, grading scale). Exclusion Criteria: Subjects with any of the following conditions on the eligibility exam may NOT be enrolled into the trial. 1. History of ocular surgery within the past 6 months. 2. Contact lens wear in either eye within 7 days of visit 1 (baseline) or use during study 3. On current topical treatment regimen for less than 3 months or anticipates any change to the regimen during the study period. 4. Use of topical steroid ocular medication or varenicline nasal spray within 4 weeks of baseline or during the study period. 5. Use of artificial tears within 2 hours prior to the baseline or study visit days. 6. Any known allergies to any component of the study drug. 7. Severe, uncontrolled autoimmune disease (e.g., rheumatoid arthritis, lupus). Uncontrolled is at the discretion of the PI. Subjects with severe systemic symptoms will not be included.
Where it's running
-
Center For Sight
Venice, Florida, United States Recruiting
Study contacts
- Study coordinator: Gina Thomas
- Email: gina.thomas@useye.com
- Phone: 9412634784
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.