Topical Menthol for Dry Eye Syndrome

(TMTS Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Reinhold Vieth

Disqualifiers: Menthol allergy, Contact lenses, Eye drops, Sensitive skin, Atopy, Stevens-Johnson, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether menthol vapors can relieve dry eye syndrome by increasing tear production. Researchers are testing a menthol solution applied to the cheek to activate cold sensors on the eye, potentially offering an alternative to eye drops for those with dry eyes. Participants should not currently receive care from an eye doctor for dry eyes and must not have used eye drops or have tears present before the test. This trial could suit individuals who frequently experience dry and sore eyes and are not allergic to menthol. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you should not use eye drops during the hour before participation.

Is there any evidence suggesting that topical menthol is likely to be safe for humans?

Research has shown that menthol can be safe for the eyes when used in certain ways. One study applied a warm compress with menthol to healthy individuals and found no harm to the tear film, which keeps eyes moist. This suggests that menthol might be well-tolerated in some forms.

This trial is in an early stage and primarily focuses on assessing safety and tolerability. So far, no serious problems have been reported when menthol is used externally, as in this trial. However, it is important to note that new methods, such as using menthol vapors, are still being tested to ensure safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for dry eye syndrome?

Unlike the standard treatments for dry eye syndrome, which often include artificial tears, anti-inflammatory drugs, or punctal plugs, topical menthol is applied directly to the skin below the eyes. Researchers are excited about this treatment because it uses menthol, which may stimulate the nerves responsible for tear production, offering a potentially new mechanism of action. This approach is also non-invasive, which could make it a more convenient and comfortable option for patients compared to other methods.

What evidence suggests that topical menthol might be an effective treatment for dry eye syndrome?

This trial will compare the effects of Topical Menthol in Oil with a Topical Placebo Oil for dry eye syndrome. Research has shown that menthol might help with dry eye syndrome by stabilizing the eye's tear layer. A recent study found that using a warm compress with menthol improved symptoms for people with dry eyes. Menthol activates cold sensors on the eye's surface, which can increase tear production. This suggests menthol could help keep eyes moist and comfortable. Early findings indicate it might be a promising alternative to traditional eye drops for some people. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for healthy individuals or those with dry eye syndrome, who may experience insufficient tear production. Participants should not have any conditions that would interfere with the study's hypothesis testing.

Inclusion Criteria

Not under care of an ophthalmologist for treatment of dry-eyes

Exclusion Criteria

Do you have a history of atopy, allergic diseases at the skin of your cheeks?

Did you use eye drops during the hour before participation?

My skin is not broken, irritated, or acne-prone where the treatment will be applied.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a menthol solution or placebo applied to the cheek to test tear secretion

1 day

1 visit (in-person)

Observation

Participants are observed for tear secretion and nasal secretion within 10 minutes of application

10 minutes

1 visit (in-person)

Follow-up

Participants are monitored for any discomfort or adverse effects after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Topical Menthol

Trial Overview

The study tests if a topical application of 20% menthol solution can stimulate tear secretion by activating cold sensors on the cornea, compared to a placebo oil without active ingredients.

How Is the Trial Designed?

Group I: Topical Menthol in Oil Experimental Treatment 1 Intervention

Menthol solution rolled onto the cheek below rim of a pair of glasses

Group II: Topical Placebo Oil only Placebo Group 1 Intervention

Oil vehicle only rolled onto the cheek below rim of a pair of glasses

Who Is Running the Clinical Trial?

Reinhold Vieth

Lead Sponsor

Stearacl Inc

Industry Sponsor

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40679590/

Which topical ophthalmic drugs work best for ...

The study concluded that cyclosporine therapy offers improvements in corneal fluorescein staining but does not significantly affect other common DED symptoms.

2.

researchgate.net

researchgate.net/publication/315953572_Effects_of_a_warm_compress_containing_menthol_on_the_tear_film_in_healthy_subjects_and_dry_eye_patients

(PDF) Effects of a warm compress containing menthol on ...

The outcomes are consistent with recent studies that show that patients with dry eye syndrome had their tear films become more stable after ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9697326/

Efficacy of Topical Administration of Corticosteroids for the ...

Concluding, topical CS administration led to an increase of SIT and a reduction of corneal staining at a mean of 10 weeks follow-up in patients ...

4.

nature.com

nature.com/articles/srep45848

Effects of a warm compress containing menthol on the tear ...

Similar to our results, a recent study found that the application of low-dose menthol ointment improved the ocular symptom score in dry eye ...

5.

hhs.texas.gov

hhs.texas.gov/sites/default/files/documents/oct-2025-durb-agenda-item04m.pdf

Gainwell Technologies - Therapeutic Class Review

In meta-analyses, cyclosporine ophthalmic emulsion demonstrated significant increases in tear production and decreases in dry eye symptoms compared with placebo ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5381094/

Effects of a warm compress containing menthol on the tear film ...

We evaluated a warm compress containing menthol as a potential treatment for dry eye by examining its effects on the tear film in healthy subjects.

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0161642025006050

Acoltremon Ophthalmic Solution 0.003% for Signs and ...

Evaluate safety and efficacy of the novel transient receptor potential melastatin 8 agonist acoltremon on signs and symptoms of dry eye disease ...

8.

malacards.org

malacards.org/card/keratoconjunctivitis_sicca

Keratoconjunctivitis Sicca (KCS)

A Multicenter, Placebo Controlled, Randomized, Double Blind, Phase II Study to Evaluate the Efficacy and Safety of SJP002 Eye Drops in Patients With Dry Eye ...

9.

go.drugbank.com

go.drugbank.com/conditions/DBCOND0054254

Dry Eyes (DBCOND0054254)

Efficacy and Safety of Fluorometholone (FML) in Dry Eye Disease (Keratoconjunctivitis Sicca). Fluorometholone. treatment, 3, completed. NCT04835623. CEQUA for ...

10.

emedicine.medscape.com

emedicine.medscape.com/article/1210417-treatment

Dry Eye Disease (Keratoconjunctivitis Sicca) Treatment & ...

This treatment modality has been shown to be safe with consistent use over 3 to 6 months and improves dry eye symptoms and tear production; may ...