Recruiting

TRYPTYR

Sponsor:

Center For Sight

Code:

NCT07277257

Conditions

Sjogren Syndrome With Keratoconjunctivitis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TRYPTYR (Acoltremon ophthalmic solution 0.003%)

Study Details

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

Study ID

NCT07277257

Start date

Dec 2, 2025

Status verified date

Dec, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Study eye

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

Interventions

TRYPTYR (Acoltremon ophthalmic solution 0.003%)

Drop to be instilled before and after endpoint measurement.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Center For Sight

Recruiting

Venice, Florida, United States, 34285

Contacts

More Information

Sponsor

Center For Sight

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Center For Sight on 2025-12-22.