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

Center For Sight

Status and phase: Enrolling; Phase 4

Conditions: Sjogren Syndrome With Keratoconjunctivitis

Treatments: Drug: TRYPTYR (Acoltremon ophthalmic solution 0.003%)

Study type: Interventional

Funder types: Other

Identifiers

NCT07277257

CFS25-004

Details and patient eligibility

About

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.

Enrollment: 35 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Subjects must fulfill the following conditions to qualify for enrollment into the trial

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

Subjects with any of the following conditions on the eligibility exam may NOT be enrolled into the trial.

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Study eye

Experimental group

Description:

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

Treatment:

Drug: TRYPTYR (Acoltremon ophthalmic solution 0.003%)