RecruitingPhase 4

Evaluating a New Therapy for Dry Eye in Patients With Sjögren's Syndrome

United States35 participantsStarted 2025-12-02

Plain-language summary

This study will evaluate the effect of TRYPTYR in patients with Sjögren's syndrome-related dry eye disease. The goal is to determine whether TRYPTYR can improve symptoms and signs of dry eye in this specific patient population.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adults over 18 years old with a diagnosis of dry eye disease (DED) secondary to Sjögren's Syndrome within the past 2 years.
✓. History of using or desiring artificial tears for DED symptoms within the past 2 months.
✓. 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

✕. History of ocular surgery within the past 6 months.
✕. Contact lens wear in either eye within 7 days of visit 1 (baseline) or use during study
✕. On current topical treatment regimen for less than 3 months or anticipates any change to the regimen during the study period.
✕. Use of topical steroid ocular medication or varenicline nasal spray within 4 weeks of baseline or during the study period.
✕. Use of artificial tears within 2 hours prior to the baseline or study visit days.
✕. Any known allergies to any component of the study drug.
✕. 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.

What they're measuring

Change from pre-instillation to 3 minutes post-TRYPTYR instillation in study eye unanesthetized Schirmer's test at Visit 1 (baseline)

Timeframe: 3 minutes

Trial details

NCT IDNCT07277257

SponsorCenter For Sight

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-31

Contact for this trial

Gina Thomas

9412634784 gina.thomas@useye.com

View on ClinicalTrials.gov More Sjogren Syndrome With Keratoconjunctivitis trials