50 Participants NeededMy employer runs this trial

Acoltremon for Dry Eye

PH
SS
Overseen BySusan Sherouse
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University of South Florida
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a new eye drop, acoltremon 0.003%, can help individuals with Stage 1 Neurotrophic Keratopathy, a condition causing dry eyes due to nerve damage. The goal is to determine if the eye drop increases tear production and improves eye health. Suitable participants have a diagnosis of this specific eye condition, along with reduced corneal sensation and dry eyes. Participants should not have eye infections or recent eye surgeries and must be able to discontinue other eye medications during the trial. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

Yes, you will need to stop using any topical eye medications 8 days before the study starts and avoid using artificial tears 2 hours before your first visit. You must stay off these medications for the entire study.

What is the safety track record for Acoltremon Ophthalmic Solution 0.003%?

Research has shown that acoltremon eye drops (0.003%) are generally safe for use. Past studies found no major safety issues, meaning users did not experience significant negative side effects. The FDA has approved this treatment for dry eye disease, indicating it is well-tolerated. Additionally, no important safety differences exist between older and younger users of acoltremon. Overall, the evidence supports acoltremon as a safe choice for managing dry eye symptoms.12345

Why are researchers enthusiastic about this study treatment?

Unlike the standard of care for dry eye, which often includes artificial tears or anti-inflammatory drops, Acoltremon Ophthalmic Solution 0.003% offers a fresh approach by using a unique active ingredient. This treatment targets the root cause of dry eye by enhancing natural tear production rather than simply providing temporary relief. Researchers are excited about Acoltremon because it has the potential to offer longer-lasting benefits and improve overall eye health, setting it apart from existing therapies that only address symptoms.

What is the effectiveness track record for Acoltremon in treating Stage 1 Neurotrophic Keratopathy?

Research has shown that Acoltremon Eye Drops 0.003% help treat dry eye by increasing natural tear production. Studies found that it significantly improves tear production and reduces dry eye symptoms. In two important studies, patients reported better results than those using a placebo. Improvements appeared quickly and persisted over time. The treatment is approved for dry eye, confirming its effectiveness.25678

Who Is on the Research Team?

PH

Pedram Hamrah, MD

Principal Investigator

University of South Florida

Are You a Good Fit for This Trial?

This trial is for people with early-stage neurotrophic keratopathy (a type of dry eye disease) who have low tear production and reduced corneal sensation. Participants must not have active eye infections, recent eye surgery, severe allergies, or be pregnant or breastfeeding.

Inclusion Criteria

Baseline unanesthetized Schirmer's test ≤ 10 mm
Best corrected distance visual acuity (BCDVA), using corrective lenses, if necessary, in the study eye of at least +1.0 Log MAR (Snellen <20/200)
I have early-stage neurotrophic keratopathy with decreased corneal sensation.
See 1 more

Exclusion Criteria

I do not have any active eye infections or inflammation inside my eye.
I have a lasting corneal ulcer, scar, or swelling in my eye.
History of severe systemic allergies or severe ocular allergies
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Acoltremon 0.003% Ophthalmic Solution to improve tear production and corneal health

8 weeks
Weekly visits for assessments

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 study tests if Acoltremon 0.003% eye drops used twice daily for 8 weeks can improve tear production in both eyes compared to standard care or artificial tears.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Acoltremon 0.003% Ophthalmic SolutionExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials
433
Recruited
198,000+

Citations

Acoltremon Ophthalmic Solution 0.003% for Signs and ...

The corneal and conjunctival staining data collected in these studies, in addition to the symptom data, suggest that persistent natural tear production ...

Acoltremon Ophthalmic Solution 0.003% for Signs and ...

Acoltremon Ophthalmic Solution 0.003% for Signs and Symptoms of Dry Eye ... dry eye: phase 3 pivotal study results. Paper presented at: AAO Annual.

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

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

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 ...

Acoltremon 0.003% ophthalmic solution in dry eye disease

Acoltremon 0.003% demonstrated statistically significant improvements in tear production in two pivotal phase 3 trials, as well as statistically ...

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.

HIGHLIGHTS OF PRESCRIBING INFORMATION These ...

No clinically relevant differences in safety have been observed between elderly and younger patients. 11 DESCRIPTION. TRYPTYR (acoltremon ophthalmic solution) ...