TRYPTYR eye drops for Sjögren's-related dry eye

Evaluating TRYPTYR as a Novel Therapy for Dry Eye in Patients With Sjögren's Syndrome

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
• Enrollment: 35 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Center For Sight (Academic / other)
• Locations: 1 site (Venice, Florida)
• Trial ID: NCT07277257 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Venice, Florida

• Center For Sight — Venice, Florida, United States (Recruiting)

Study contacts

• Study coordinator: Gina Thomas

Conditions Sjogren Syndrome With Keratoconjunctivitis