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Recruiting NCT07277257

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

Phase IV Interventional Sjogren Syndrome With Keratoconjunctivitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TRYPTYR (Acoltremon ophthalmic solution 0.003%).
Who it may be relevant to
Registry conditions: Sjogren Syndrome With Keratoconjunctivitis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug TRYPTYR (Acoltremon ophthalmic solution 0.003%)
    Drop to be instilled before and after endpoint measurement.

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

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 criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Center For Sight — Venice

Identifiers

NCT: NCT07277257 · CFS25-004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗