Evaluating a New Therapy for Dry Eye in Patients With Sjögren's Syndrome
Recruiting now · Phase 4
Conditions studied: Sjogren Syndrome With Keratoconjunctivitis
In brief
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.
Key facts
- Study ID
- NCT07277257
- Run by
- Center For Sight
- People needed
- 35
- Starts
- 2025-12-02
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-12-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subjects must fulfill the following conditions to qualify for enrollment into the trial
- 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).
You may not qualify if…
- Subjects with any of the following conditions on the eligibility exam may NOT be enrolled into the trial.
- 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.
Where it is running
- Center For Sight — Venice, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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