Acoltremon for Dry Eye

Overseen By Gina Thomas

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Center For Sight

Must not be taking: Topical steroids, Varenicline

Disqualifiers: Ocular surgery, Contact lenses, Allergies, others

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: 1

Duration: 3 minutes

35 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new eye drop treatment, Acoltremon, can help people with dry eyes caused by Sjögren's syndrome. The goal is to determine if it can relieve symptoms like dryness and irritation. Participants should have been diagnosed with Sjögren's-related dry eye in the last two years and have used or wanted to use artificial tears recently. Those who have had recent eye surgery or regularly wear contact lenses may not qualify for this trial. As a Phase 4 trial, Acoltremon is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial requires that you stop using certain medications, like topical steroid eye drops and varenicline nasal spray, at least 4 weeks before starting. You also can't use artificial tears within 2 hours before any study visits.

What is the safety track record for Acoltremon ophthalmic solution 0.003%?

Previous studies found no major safety issues with Acoltremon eye drops. These studies assessed how well people tolerated the treatment, and most reported no serious problems. Acoltremon already treats dry eye disease, providing some confidence in its safety for this condition. However, individual reactions can vary, and side effects may still occur. Prospective participants should consult their doctor before joining a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for dry eye often focus on lubricating the eyes or reducing inflammation, like artificial tears or anti-inflammatory drops. But Acoltremon works differently. It is an ophthalmic solution that potentially offers a novel mechanism of action by targeting the underlying causes of dry eye, possibly providing more effective relief. Researchers are excited because this could mean longer-lasting results and improved comfort for those who struggle with dry eyes.

What is the effectiveness track record for Acoltremon in treating dry eye?

Research has shown that Acoltremon eye drops (0.003%) effectively treat dry eye disease. Studies have found that this treatment significantly increases tear production and reduces dry eye symptoms. For example, one study noted a lasting improvement in tear production, measured by a test for eye moisture, with noticeable results starting on Day 1 and continuing through Day 14. More patients using Acoltremon experienced a meaningful increase in tear production compared to those who did not use it. This suggests that Acoltremon can provide real relief for people with dry eye symptoms. ^{4 5 6 7 8}

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TRYPTYR to evaluate its effect on dry eye symptoms in Sjögren's syndrome

3 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

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+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12577975/

Acoltremon and the TRPM8 frontier: a new chapter in dry ...

In the preceding phase 2b study, 0.003% Acoltremon showed sustained improvements in unanesthetized Schirmer score (Days 1 and 14, p < 0.0001), ...

2.

ophthalmologyadvisor.com

ophthalmologyadvisor.com/news/acoltremon-improves-tear-production-dry-eye/

Acoltremon Elicits Sustained Efficacy in Dry Eye Disease

Acoltremon 0.003% ophthalmic solution significantly increased tear production and improved dry eye disease symptoms in two Phase 3 studies.

3.

aaojournal.org

aaojournal.org/article/S0161-6420(25)00605-0/fulltext

Acoltremon Ophthalmic Solution 0.003% for Signs and ...

To evaluate the safety and efficacy of the transient receptor potential melastatin 8 agonist acoltremon on signs and symptoms of dry eye disease (DED). Design.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0161642025006050

Acoltremon Ophthalmic Solution 0.003% for Signs and ...

A significantly higher proportion of ACO-treated subjects achieved a clinically meaningful increase in tear production (≥ 10-mm increase in UST ...

5.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2025/217370Orig1s000IntegratedR.pdf

217370Orig1s000 - accessdata.fda.gov

– OTC Monograph eye drops. Tryptyr (acoltremon ophthalmic solution) 0.003% would provide an alternative product for the treatment of DED by ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2025/217370Orig1s000RiskR.pdf

217370Orig1s000 - accessdata.fda.gov

The applicant was informed that based on the currently available data, no significant safety concerns had been identified to date. 3.

7.

tryptyr.myalcon.com

tryptyr.myalcon.com/

TRYPTYR (acoltremon ophthalmic solution) 0.003% eye ...

TRYPTYR is a prescription eye drop used for the treatment of the signs and symptoms of dry eye disease. See prescribing information, how to save, and more.

8.

drugs.com

drugs.com/dosage/acoltremon-ophthalmic.html

Acoltremon Ophthalmic Dosage - Drugs.com

Liver Dose Adjustments. Data not available ; Precautions. CONTRAINDICATIONS: None Safety and efficacy have not been established in patients ...