NCT07109609

Topical Menthol For Tear Secretion

Topical Menthol for Tear Secretion

• Status: Enrolling By Invitation
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Reinhold Vieth · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	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 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.

Timeline

• Start date: 2025-08-17
• Primary completion: 2025-11-07
• Completion: 2025-12-01
• First posted: 2025-08-07
• Last updated: 2025-09-16

Locations

1 site across 1 country: Canada