Acoltremon for Dry Eye Syndrome

(TRYPTYR ADL Trial)

Recruiting at 2 trial locations

Overseen By Quentin Franklin, BS, BA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Southern College of Optometry

Must be taking: Restasis

Must not be taking: Accutane, Ocular medications

Disqualifiers: Sjögren's syndrome, Ocular surgery, Pregnant, 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: 3

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called Acoltremon to determine its effectiveness for people with Dry Eye Syndrome, a condition causing dry and irritated eyes. The research targets individuals who have experienced dry eye symptoms for at least six months and find their current treatment unsatisfactory. Ideal participants are those using Restasis who plan to stop due to its ineffectiveness and whose symptoms hinder their work. 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?

You will need to stop using any dry eye medications or treatments at least 1 week before joining the study, except for Restasis, which you can continue using.

What is the safety track record for Acoltremon?

Research has shown that Acoltremon, also known as TRYPTYR, has undergone thorough safety testing. In past studies, 766 patients with dry eye disease used TRYPTYR, and researchers found no major safety issues. The FDA approved Acoltremon for treating dry eye disease, indicating it passed strict safety tests for this use. Overall, Acoltremon appears well-tolerated by patients, with no serious side effects reported to date. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard treatments for dry eye syndrome, which often include artificial tears and anti-inflammatory medications, Acoltremon is unique because it targets the underlying mechanisms of dry eye disease. Researchers are excited about Acoltremon because it offers a novel approach by potentially modulating nerve responses to reduce symptoms. This could lead to more effective and longer-lasting relief compared to existing options, providing hope for patients seeking better management of their condition.

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

Studies have shown that Acoltremon significantly improves symptoms of dry eye disease (DED). In clinical research, Acoltremon increased tear production and reduced other signs of DED. Some patients experienced relief as soon as the first day of treatment. The FDA has already approved the treatment, confirming its effectiveness in alleviating dry eye symptoms. These findings suggest that Acoltremon may effectively assist those struggling with DED. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

Adults over 18 with Dry Eye Syndrome (DED) for at least 6 months, currently experiencing symptoms (Eye Dryness Score ≥40), and a Schirmer test result of less than 10 mm/5 min. Participants should have work impacted by DED, as indicated by scoring ≤70 on the IDEEL Work domain.

Inclusion Criteria

Corrected distance visual acuity of 20/100 or better

Willing to discontinue contact lens wear throughout the study

I am 18 years old or older.

Exclusion Criteria

Pregnant or breast feeding

Condition or situation that, in the investigator's opinion, may put the participant at significant risk, may confound the results, or may significantly interfere with their study participation

I have used Accutane or eye medications but stopped them a week ago, except for Restasis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TRYPTYR to determine its effect on dry eye disease symptoms and quality of life

4 weeks

3 visits (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

Trial Overview The trial is testing Acoltremon's effect on quality of life and work performance in people with DED. It involves three visits over one month at select locations in Memphis, Pittsburg, and Minneapolis.

How Is the Trial Designed?

Group I: TRYPTYR Experimental Treatment 1 Intervention

Participants who qualify for the study will be given TRYPTYR to determine if it is able to help alleviate symptoms associated with dry eye disease;

Who Is Running the Clinical Trial?

Southern College of Optometry

Lead Sponsor

Trials

8

Recruited

390+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41038456/

Results of Phase 3 Pivotal COMET-2 and COMET-3 Studies Acoltremon Ophthalmic Solution 0.003% for Signs and Symptoms of Dry Eye Disease: Results of Phase 3 Pivotal COMET-2 and COMET-3 Studies.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0161642025006050

Acoltremon Ophthalmic Solution 0.003% for Signs and ... In both phase 3 studies, ACO compared with VEH led to consistent, clinically meaningful tear production as well as reductions in other DED signs ...

3. 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.

4. 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.

5. investor.alcon.com investor.alcon.com/news-and-events/press-releases/news-details/2025/Alcon-Announces-FDA-Approval-of-TRYPTYR-acoltremon-ophthalmic-solution-0-003-for-the-Treatment-of-the-Signs-and-Symptoms-of-Dry-Eye-Disease/default.aspx

Alcon Announces FDA Approval of TRYPTYR (acoltremon ... TRYPTYR demonstrated statistically significant natural tear production as early as Day 1.1-2. “Many of my patients continue to face frustrating ...

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. va.gov va.gov/formularyadvisor/DOC_PDF/MON_Acoltremon_TRYPTYR_monograph_Aug_2025.pdf

Acoltremon ophthalmic solution (TRYPTYR) National Drug ... • Acoltremon is indicated for the treatment of the signs and symptoms of dry eye disease. Dosage Form(s) Under Review. • Ophthalmic solution: 0.003 ...

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

Acoltremon and the TRPM8 frontier: a new chapter in dry ... A new era in dry eye disease treatment begins with the FDA approval of Acoltremon, sold under the name TRYPTYR (0.003% ophthalmic solution). It ...

9. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2025/217370s000lbl.pdf

HIGHLIGHTS OF PRESCRIBING INFORMATION These ... In patients with dry eye disease, 766 patients received at least one dose of TRYPTYR in four randomized controlled clinical trials across 71 sites in the ...