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RecruitingPhase 4NCT07277257

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

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

Sponsor

Center For Sight

Enrollment

35 participants

Start Date

Dec 2, 2025

Study Type

INTERVENTIONAL

Conditions

Sjogren Syndrome With Keratoconjunctivitis

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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).

Exclusion Criteria8

  • 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.

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Interventions

DRUGTRYPTYR (Acoltremon ophthalmic solution 0.003%)

Drop to be instilled before and after endpoint measurement.

Locations(1)

Center For Sight

Venice, Florida, United States

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NCT07277257