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NOT YET RECRUITING
NCT07888452
PHASE4

Cooling Eyedrops for Dry Eye

Sponsor: University of California, Berkeley

View on ClinicalTrials.gov

Summary

In dry eye (DE), either insufficient aqueous tears are produced or the tears evaporate off the ocular surface too quickly. Meibomian gland dysfunction (MGD) results in poor quality or insufficient meibum being expressed during blinking, leading to a thinner tear lipid layer and faster aqueous tear evaporation. MGD is a major factor in evaporative dry eye globally. Activation of TRPM8 receptors on the cornea and eyelid margins gives a cooling sensation, which may increase the basal production of both aqueous tears and meibum through parasympathetic neural circuitry. The investigators hypothesize that acoltremon (TRYPTYR) 0.003% eye drops can increase tear lipid layer thickness and reduce the tear thinning rate.

Official title: Impact of TRPM8 Agonist on Tear-lipid Thickness

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-11

Completion Date

2027-07

Last Updated

2026-10-26

Healthy Volunteers

No

Conditions

Interventions

DRUG

TRYPTYR Eye Drops

At baseline, a single drop of acoltremon 0.003% (TRYPTYR) eye drops will be instilled in each eye. After 10 minutes, 1 hour, and 2 hours, tear lipid layer thickness and tear thinning rate will be measured. At each time point, subject will be administered a brief questionnaire about how their eyes feel.

OTHER

Purilens Plus Non-Preserved Saline Eye Drops

At baseline, a single drop of Purilens Plus over-the-counter non-preserved saline solution eye drops will be instilled in each eye. After 10 minutes, 1 hour, and 2 hours, tear lipid layer thickness and tear thinning rate will be measured. At each time point, subject will be administered a brief questionnaire about how their eyes feel.

Locations (1)

U.C. Berkeley Clinical Research Center

Berkeley, California, United States