Topical Menthol For Tear Secretion

NCT ID: NCT07109609

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-17
• Study Completion Date: 2025-12-01

Brief 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. 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).

Conditions

Healthy; Dry Eyes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Topical Menthol in Oil

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

Group Type: EXPERIMENTAL

Topical application of 20% menthol solution in MCT oil.

Intervention Type: 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 only

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

Group Type: PLACEBO_COMPARATOR

Topical Placebo Oil rolled onto the cheek.

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Not under care of an opthalmologist for treatment of dry-eyes

Exclusion Criteria

• • 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? ____

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stearacl Inc

INDUSTRY

Sponsor Role: collaborator

Reinhold Vieth

INDUSTRY

Sponsor Role: lead

Responsible Party

Reinhold Vieth

CEO Stearacl Inc, Canada

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Stearacl Incorporated.

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

M240706

Identifier Type: -

Identifier Source: org_study_id