Evaluating a New Therapy for Dry Eye in Patients With Sjögren's Syndrome
NCT ID: NCT07277257
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
35 participants
INTERVENTIONAL
2025-12-02
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Study eye
The study eye is the eye with the lower pre-drop unanesthetized Schirmer score performed at the baseline visit.
TRYPTYR (Acoltremon ophthalmic solution 0.003%)
Drop to be instilled before and after endpoint measurement.
Interventions
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TRYPTYR (Acoltremon ophthalmic solution 0.003%)
Drop to be instilled before and after endpoint measurement.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Center For Sight
OTHER
Responsible Party
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Locations
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Center For Sight
Venice, Florida, United States
Countries
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Central Contacts
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Facility Contacts
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Gina Thomas
Role: primary
Other Identifiers
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CFS25-004
Identifier Type: -
Identifier Source: org_study_id