Acoltremon for Dry Eye

Overseen By Gina Thomas

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Center For Sight

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

This trial is for individuals with Sjögren's syndrome who are experiencing dry eye symptoms. Specific eligibility criteria have not been provided, but typically participants would need to meet certain health standards and not be using conflicting medications or treatments.

Inclusion Criteria

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)

I am over 18 and was diagnosed with dry eye from Sjögren's Syndrome in the last 2 years.

I have used or wanted to use artificial tears for dry eye symptoms recently.

Exclusion Criteria

I've been using my current skin treatment for less than 3 months and might change it soon.

I have had eye surgery in the last 6 months.

I haven't used steroid eye drops or varenicline nasal spray in the last 4 weeks.

What Are the Treatments Tested in This Trial?

Interventions

• Acoltremon ophthalmic solution 0.003%

Trial Overview The trial is testing the effectiveness of a new ophthalmic solution called Acoltremon (0.003%) in improving symptoms and signs of dry eye disease in patients with Sjögren's syndrome.

How Is the Trial Designed?

Group I: Study eye Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Center For Sight

Lead Sponsor

Trials

2

Recruited

90+