HealthyPhase 2TMTSNCT07109609
Topical Menthol For Tear Secretion
A Phase 2 study testing Topical application of 20% menthol solution in MCT oil. in people with Healthy and Dry Eyes, run by Reinhold Vieth at 1 site in Canada.
Trial summary
Tears are the natural way to keep eyes moist, and tears are important for good vision and healthy eyes. Eyes without enought tears get dry and sore. The natural and normal way to stimulate secretion of tears is by turning on cold sensors that are located on the cornea of the eye. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Topical application of 20% menthol solution in MCT oil.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 17 Aug 2025to 1 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Not under care of an opthalmologist for treatment of dry-eyes
Who cannot join
- • Excluded if "Yes" to any of the questions below.
- Are you allergic to menthol or to menthol-containing products like tooth paste or certain cold remedies?
- Are you wearing contact lenses during the time of testing? ________
- Are there tears present prior to applying the menthol? ________
- Did you use of eye drops during the hour before participation? ________
- Do you have broken, irritated, sensitive skin and/or acne at or around application site? ________
- Do you have a history of atopy, allergic diseases at the skin of your cheeks?
- Do you have Stevens-Johnson syndrome, which is any known skin response to chemical, thermal, or radiation injury to the application area? ____
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Topical Menthol for Tear Secretion
Tears are the natural way to keep eyes moist, and tears are important for good vision and healthy eyes. Eyes without enought tears get dry and sore.
The natural and normal way to stimulate secretion of tears is by turning on cold sensors that are located on the cornea of the eye. Tear are normally released across the eyeball in a finely balanced system that balances out that natural evaporation. But sometimes there is not enough tear secretion to balance out the evaporation of tears and eyes can get sore.
Read more
The aim here is to test whether menthol in its vapor form may possibly turn on those cold sensors and thus cause secretion of tears. Use of menthol vapors may be like having a switch to release more tears.
The aim of this clinical trial is to test the hypothesis that a menthol solution applied onto a cheek will release enough menthol vapor into the air flowing up over the eye's cornea to stimulate cold sensors enough to make a tear flow from the eye.
If the hypothesis that menthol safely stimulates tear secretion in healthy people proves to be correct, then this clinical trial may inspire more new research into the use of menthol as an alternative to the use of eye drops for some people.
Read the detailed description
This is a proof-of-principle clinical trial. It is a double-blind, placebo-controlled, randomized clinical trial. Participants are not being seen by a physician for eye disease, and there is a 50% probability that a participant will receive active treatment, or 50% probability that they will just receive the carrier oil with nothing in it (placebo).
- Being tested
- Topical application of 20% menthol solution in MCT oil., Topical Placebo Oil rolled onto the cheek.
- Keywords
- tear secretion, dry eyes, eye drops, menthol, vapor, cornea
- Medical subject headings
- Dry Eye Syndromes, Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical application of 20% menthol solution in MCT oil.Drug
To facilitate reproducible and correct application of the solution, the subject wears glasses while the product is applied. The solution is rolled onto one cheek by rolling it to an area of about 2cm X 2cm at the cheekbone, underneath the bottom rim of the glasses worn. This method delivers about 12 mg solution, i.e. 2.4 mg menthol to one cheek. Or this method delviers 12 mg of placebo oil. The subject then sits in still air for 5 minutes, at which point tissue is wiped across the skin below the bottom eyelashes to permit the weighing of secreted tear.
Topical Placebo Oil rolled onto the cheek.Drug
To facilitate reproducible and correct application of the Placebo oil, the subject wears glasses while the product is applied. The Placebo oil is rolled onto one cheek by rolling it to an area of about 2cm X 2cm at the cheekbone, underneath the bottom rim of the glasses worn. This method delivers zero active agent. The subject then sits in still air for 5 minutes, at which point tissue is wiped across the skin below the bottom eyelashes to permit the weighing of secreted tear.
| Study group | Role | What they receive |
|---|---|---|
| Topical Menthol in Oil | Experimental | Menthol solution rolled onto the cheek below rim of a pair of glasses Receives: Drug: Topical application of 20% menthol solution in MCT oil. |
| Topical Placebo Oil only | Placebo comparator | Oil vehicle only rolled onto the cheek below rim of a pair of glasses Receives: Drug: Topical Placebo Oil rolled onto the cheek. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective measure of tear stimulation Yes or No
The outcome is the binary yes/no observation of active tear secretion that overflows to the skin below the bottom eyelashes. Subject sits in still air while wearing glasses to ensure correct positioning of the topical application. The solution of menthol or placebo is dispensed from a roller-ball bottle to the right eye only, onto an area about 2cm x 2 cm just below the bottom rim of the glasses; that is, inferior to the pupil, and in line with the bottom of the nose. Within 5 minutes of sitting in still air, If moisture is evident below the bottom eyelashes, glasses are removed and tissue is dabbed, or wiped under bottom eyelash to take up the tear. If that wipe increases the weight of the tissue by at least 6 milligrams, then a "Yes" response is recorded. If after 5 minutes a wipe of tissue across the bottom eyelashes of the right eye does not increase the weight of tissue by at least 6 milligrams, a "No" is recorded to indicate that there was no increase in tear secretion.
Measured: Participant is observed for 5 minutes after application, to record tear-weight data, and the related questions that are asked are completed within 10 minutes after applicaiton.
Weight of tear
The actual measured weight of the tear(s) collected onto the tissue, from below the right eye.
Measured: Measured at 5 minutes after dose application.
Was there a subjective difference between left and right eyes in terms of sense if moisture
Response to the question: " Which eye feels more moist? Left eye more moist or No difference (both same) or ….Right eye more moist"
Measured: 5 to 10 minutes after application
Weight of nasal secretion blown into tissue.
The purpose is to test whether there is evidence of shared innervation of TRPM8 receptors (the menthol-responsive sensors for cold) in cornea and nasal subepithelium. The particpant holds closed the left nostril, while blowing into a tissue from the right nostril. The increase in weight of tissue is measured.
Measured: Within 10 minutes of applying the dose.
Secondary outcomes (4)
Weight of nasal secretion
Subject blows their nose into a tissue, and the increase in tissue weight is recorded.
Measured: 5 to 10 minutes after application
Discomfortable feeling at the treated eye.
At your right eye, was there anything uncomfortable feeling? Nothing mild moderate severe (choose one)
Measured: 10 minutes
Degree of cooling or pain at the skin where the dose was applied.
At the skin of the cheek, where it was rolled on, did you feel (choose one) COOLING OR NOTHING OR PAIN If cooling or pain, how strong was the feeling? (choose one) Nothing mild moderate severe
Measured: 10 minutes
Did the procedure increase sense of runny nose?
Did you feel a runny nose, or nasal secretion during the 5 minutes of waiting? No or Yes And if Yes, at which nostril? Left or Right or Both nostrils
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start17 Aug 2025
- Primary completion7 Nov 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Reinhold Vieth
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Stearacl Inc
- Responsible party
- Sponsor-investigator, Reinhold Vieth, Stearacl Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109609
- Sponsor's protocol ID
- M240706
- Acronym
- TMTS
- Status last verified
- Jul 2025
- First submitted
- 30 Jul 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A spreadsheet of anonymized IPD collected throughout the trial may be made upon inquiry with the corresponding author of any peer-reviewed publication ensuing from this work.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Menthol for Tear Secretion
- ClinicalTrials.gov ID
- NCT07109609
- Acronym / sponsor ID
- TMTS / M240706
- Keywords
- tear secretion, dry eyes, eye drops, menthol, vapor, cornea
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Reinhold ViethIndustry (pharma, biotech, devices)
- Collaborators
- Stearacl Inc
- Study start
- 17 Aug 2025 (actual)
- Primary completion
- 7 Nov 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tears are the natural way to keep eyes moist, and tears are important for good vision and healthy eyes. Eyes without enought tears get dry and sore.
The natural and normal way to stimulate secretion of tears is by turning on cold sensors that are located on the cornea of the eye. Tear are normally released across the eyeball in a finely balanced system that balances out that natural evaporation. But sometimes there is not enough tear secretion to balance out the evaporation of tears and eyes can get sore.
The aim here is to test whether menthol in its vapor form may possibly turn on those cold sensors and thus cause secretion of tears. Use of menthol vapors may be like having a switch to release more tears.
The aim of this clinical trial is to test the hypothesis that a menthol solution applied onto a cheek will release enough menthol vapor into the air flowing up over the eye's cornea to stimulate cold sensors enough to make a tear flow from the eye.
If the hypothesis that menthol safely stimulates tear secretion in healthy people proves to be correct, then this clinical trial may inspire more new research into the use of menthol as an alternative to the use of eye drops for some people.
Detailed description
This is a proof-of-principle clinical trial. It is a double-blind, placebo-controlled, randomized clinical trial. Participants are not being seen by a physician for eye disease, and there is a 50% probability that a participant will receive active treatment, or 50% probability that they will just receive the carrier oil with nothing in it (placebo).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical Menthol in Oil | Experimental | Drug: Topical application of 20% menthol solution in MCT oil.Menthol solution rolled onto the cheek below rim of a pair of glasses |
| Topical Placebo Oil only | Placebo comparator | Drug: Topical Placebo Oil rolled onto the cheek.Oil vehicle only rolled onto the cheek below rim of a pair of glasses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Not under care of an opthalmologist for treatment of dry-eyes
Key exclusion criteria (8 listed)
- • Excluded if "Yes" to any of the questions below.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Topical application of 20% menthol solution in MCT oil.To facilitate reproducible and correct application of the solution, the subject wears glasses while the product is applied. The solution is rolled onto one cheek by rolling it to an area of about 2cm X 2cm at the cheekbone, underneath the bottom rim of the glasses worn. This method delivers about 12 mg solution, i.e. 2.4 mg menthol to one cheek. Or this method delviers 12 mg of placebo oil. The subject then sits in still air for 5 minutes, at which point tissue is wiped across the skin below the bottom eyelashes to permit the weighing of secreted tear. | Drug | Topical Menthol in Oil |
| Topical Placebo Oil rolled onto the cheek.To facilitate reproducible and correct application of the Placebo oil, the subject wears glasses while the product is applied. The Placebo oil is rolled onto one cheek by rolling it to an area of about 2cm X 2cm at the cheekbone, underneath the bottom rim of the glasses worn. This method delivers zero active agent. The subject then sits in still air for 5 minutes, at which point tissue is wiped across the skin below the bottom eyelashes to permit the weighing of secreted tear. | Drug | Topical Placebo Oil only |
Primary outcome
Objective measure of tear stimulation Yes or No
Time frame: Participant is observed for 5 minutes after application, to record tear-weight data, and the related questions that are asked are completed within 10 minutes after applicaiton.
The outcome is the binary yes/no observation of active tear secretion that overflows to the skin below the bottom eyelashes. Subject sits in still air while wearing glasses to ensure correct positioning of the topical application. The solution of menthol or placebo is dispensed from a roller-ball bottle to the right eye only, onto an area about 2cm x 2 cm just below the bottom rim of the glasses; that is, inferior to the pupil, and in line with the bottom of the nose. Within 5 minutes of sitting in still air, If moisture is evident below the bottom eyelashes, glasses are removed and tissue is dabbed, or wiped under bottom eyelash to take up the tear. If that wipe increases the weight of the tissue by at least 6 milligrams, then a "Yes" response is recorded. If after 5 minutes a wipe of tissue across the bottom eyelashes of the right eye does not increase the weight of tissue by at least 6 milligrams, a "No" is recorded to indicate that there was no increase in tear secretion.
Weight of tear
Time frame: Measured at 5 minutes after dose application.
The actual measured weight of the tear(s) collected onto the tissue, from below the right eye.
Was there a subjective difference between left and right eyes in terms of sense if moisture
Time frame: 5 to 10 minutes after application
Response to the question: " Which eye feels more moist? Left eye more moist or No difference (both same) or ….Right eye more moist"
Weight of nasal secretion blown into tissue.
Time frame: Within 10 minutes of applying the dose.
The purpose is to test whether there is evidence of shared innervation of TRPM8 receptors (the menthol-responsive sensors for cold) in cornea and nasal subepithelium. The particpant holds closed the left nostril, while blowing into a tissue from the right nostril. The increase in weight of tissue is measured.
4 secondary outcomes
Weight of nasal secretion
Time frame: 5 to 10 minutes after application
Discomfortable feeling at the treated eye.
Time frame: 10 minutes
Degree of cooling or pain at the skin where the dose was applied.
Time frame: 10 minutes
Did the procedure increase sense of runny nose?
Time frame: 10 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: Yes. A spreadsheet of anonymized IPD collected throughout the trial may be made upon inquiry with the corresponding author of any peer-reviewed publication ensuing from this work.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Topical application of 20% menthol solution in MCT oil. in people with Healthy and Dry Eyes, run by Reinhold Vieth at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective measure of tear stimulation Yes or No (time frame: Participant is observed for 5 minutes after application, to record tear-weight data, and the related questions that are asked are completed within 10 minutes after applicaiton.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2025.