A Phase 4 interventional study of Treatment and Control in Dry Eye, sponsored by University of California, Berkeley. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by University of California, Berkeley · Phase 4, Interventional, and Treatment
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.
Background:
A TRPM8 agonist is a cooling agent, which could mimic the sensation of evaporative cooling of the ocular surface. It is conceivable that the human body perceives this cooling sensation as a sign of excessive tear film thinning or evaporation. As a result, the production of tear film components (both aqueous and meibum) may be up-regulated through a negative feedback loop (common in many biological functions) to maintain tear film homeostasis. It is also possible that the TRPM8 agonist alters the blinking pattern as the cooling sensation may lead to an increase in blink frequency. If the frequency of "complete" blinks increases, more meibum will be expressed due to the pressure on the Meibomian gland orifices when upper and lower eyelids meet, resulting in more lipid oil being spread onto the ocular surface. Finally, TRPM8 receptors have been found on the cornea and the eyelid margins; therefore, activation of these receptors may increase the basal production of both aqueous and meibum through parasympathetic neural circuitry. The investigators hypothesize that acoltremon (TRYPTYR) 0.003% eye drops can increase tear lipid thickness and reduce tear thinning rate.
Unmet Medical Need:
The effect of acoltremon (Tryptyr) 0.003% eye drops on tear film dynamics including tear lipid thickness and its uniformity as well as tear thinning rate has not been examined. Tear film stability depends heavily on having a sufficiently thick and uniform lipid layer, and this lipid film also influences the dynamic processes of tear thinning and breakup, not just tear production. Current studies of TRPM8 agonist eye drops have focused on tear volume and improvements in dry eye symptoms. While prior studies of TRPM8 agonist eye drops have demonstrated effects on tear volume and tear lipid concentration, their impact on tear film dynamics, including lipid layer thickness and tear thinning rate, has not been systematically characterized.
1,325 studies on the registry are indexed under Dry Eye Syndromes; 193 are open to participants now.
This study's planned enrollment of 50 is below the median of 60 across 1,103 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →University of California, Berkeley is the lead sponsor of 110 studies on the registry; 19 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
25 subjects will be randomized to receive the Treatment eye drops.
Drug: Treatment
25 subjects will be randomized to receive the Control eye drops.
Other: Control
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.
Also known as: TRYPTYR
At baseline, a single drop of 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.
Also known as: Over-the-counter non-preserved saline solution eye drops
Tear lipid layer thickness (nm)
Post-eye drop instillation, the LipiView interferometer will be used to measure the thickness of the tear lipid layer on both eyes.
Time frame: 10 minutes, 1 hour, and 2 hours after eye drop instillation
Tear thinning rate (%/sec)
Post-eye drop instillation, the EasyTear VIEW+ tearscope will be used to measure the rate of tear aqueous thinning on both eyes.
Time frame: 10 minutes, 1 hour, and 2 hours after eye drop instillation
Ocular Sensation Survey
Post-eye drop instillation, subjects will be administered a two-item questionnaire about how their eyes feel.
Time frame: 10 minutes, 1 hour, and 2 hours after eye drop instillation
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Nov 2026; primary completion for May 2027, 6 months later.
Of 81 non-industry phase 4 interventional studies under Dry Eye Syndromes, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's planned 6 months is below that.
Counting every sponsor, half of 111 studies reached it within 13 months; a quarter within 5 and three quarters within 24.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of California, Berkeley →