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

NCT07277257 | Recruiting Phase 4 FDA Drug

• 1 other identifier: CFS25-004
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sjogren Syndrome With Keratoconjunctivitis

Outcome Measures

Primary Outcomes (1)

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

  Unanesthetized Schirmer's test will be measured prior to instillation and then again 3 minutes after instillation of the TRYPTYR. The difference between the 2 measurements will be compared.

  3 minutes

Study Arms (1)

Study eye

EXPERIMENTAL

The study eye is the eye with the lower pre-drop unanesthetized Schirmer score performed at the baseline visit.

Drug: TRYPTYR (Acoltremon ophthalmic solution 0.003%)

Interventions

TRYPTYR (Acoltremon ophthalmic solution 0.003%) DRUG

Drop to be instilled before and after endpoint measurement.

Study eye

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Center For Sight: lead

Study Sites (1)

Center For Sight

Venice, Florida, 34285, United States

RECRUITING

Central Study Contacts

Gina Thomas

CONTACT

9412634784; gina.thomas@useye.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 11, 2025
• Study Start: December 2, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (1)