Dry EyePhase 4NCT07888452
Cooling Eyedrops for Dry Eye
A Phase 4 study testing TRYPTYR Eye Drops and Purilens Plus Non-Preserved Saline Eye Drops in people with Dry Eye, run by University of California, Berkeley at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- TRYPTYR Eye Drops and Purilens Plus Non-Preserved Saline Eye Drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jul 2027
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Best corrected visual acuity 20/25 or better in each eye
- Diagnosis of evaporative dry eye disease within the last 6 months
- Able to understand and sign informed consent
- Able and willing to comply with visit schedule
- Able and willing to undergo all planned assessments
- Baseline LipiView tear lipid layer thickness ≤50nm
Who cannot join
- Subjects with a condition or in a situation which, in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study
- Use of contact lenses within 24 hours of study
- Use of OTC eye drops or ocular medications within 24 hours of study
- Currently using any prescription topical eye medication
- Having known systemic health conditions that might alter tear film physiology
- Having a history of viral eye disease
Show all 16Show fewer
- Having a history of diabetes
- Having a history of ocular surgery
- Having a history of severe ocular trauma
- Having an active ocular infection or inflammation
- Currently using isotretinoin-derivatives
- Pregnant or breastfeeding
- Taking antihistamines, antianxiety agents, antidepressants, antimuscarinics, or any other drug known to cause or exacerbate dry eye
- Having lid margin inflammation or erythema
- Having visible capped meibomian glands
- Having collarettes or signs of demodex blepharitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
U.C. Berkeley Clinical Research Center
Berkeley, California, 94720
Meng C. Lin, OD, PhD, 510-643-9252, mlin@berkeley.edu
Laimeng Lee, OD, MS, 510-643-9252, laimenglee@berkeley.edu
About this study
Official title: Impact of TRPM8 Agonist on Tear-lipid Thickness
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.
Read the detailed description
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.
- Conditions
- Dry Eye
- Being tested
- TRYPTYR Eye Drops, Purilens Plus Non-Preserved Saline Eye Drops
- Keywords
- acoltremon (Tryptyr) 0.003%, dry eye, ophthalmic eye drops, tear lipid layer, tear thinning
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRYPTYR Eye DropsDrug
Also called acoltremon 0.003% 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.
Purilens Plus Non-Preserved Saline Eye DropsOther
Also called Over-the-counter non-preserved saline solution 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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | 25 subjects will be randomized to receive the Treatment eye drops. Receives: Drug: TRYPTYR Eye Drops |
| Control | Placebo comparator | 25 subjects will be randomized to receive the Control eye drops. Receives: Other: Purilens Plus Non-Preserved Saline Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 10 minutes, 1 hour, and 2 hours after eye drop instillation
Secondary outcomes (1)
Ocular Sensation Survey
Post-eye drop instillation, subjects will be administered a two-item questionnaire about how their eyes feel. The first item asks "Do your eyes feel different after using the eye drop?", Likert scale answers are [Much Better, A Little Better, No Change, A Little Worse, Much Worse]. The second item asks respondents to circle all that apply from a list of sensations, [Soothing, Comfortable, Pleasant, Cooling, Tingling, Burning, Stinging, Irritation, Discomfort, Wet, Tearing, Other: (please specify)].
Measured: 10 minutes, 1 hour, and 2 hours after eye drop instillation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07888452
- Sponsor's protocol ID
- 103232843
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of TRPM8 Agonist on Tear-lipid Thickness
- ClinicalTrials.gov ID
- NCT07888452
- Acronym / sponsor ID
- 103232843
- Conditions
- Dry Eye
- Keywords
- acoltremon (Tryptyr) 0.003%, dry eye, ophthalmic eye drops, tear lipid layer, tear thinning
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Nov 2026 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 22 Oct 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: TRYPTYR Eye Drops25 subjects will be randomized to receive the Treatment eye drops. |
| Control | Placebo comparator | Other: Purilens Plus Non-Preserved Saline Eye Drops25 subjects will be randomized to receive the Control eye drops. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Best corrected visual acuity 20/25 or better in each eye
- Diagnosis of evaporative dry eye disease within the last 6 months
- Able to understand and sign informed consent
- Able and willing to comply with visit schedule
Key exclusion criteria (16 listed)
- Subjects with a condition or in a situation which, in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study
- Use of contact lenses within 24 hours of study
- Use of OTC eye drops or ocular medications within 24 hours of study
- Currently using any prescription topical eye medication
- Having known systemic health conditions that might alter tear film physiology
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 |
|---|---|---|
| TRYPTYR Eye DropsAlso: acoltremon 0.003% Eye DropsAt 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. | Drug | Treatment |
| Purilens Plus Non-Preserved Saline Eye DropsAlso: Over-the-counter non-preserved saline solution eye dropsAt 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. | Other | Control |
Primary outcome
Tear lipid layer thickness (nm)
Time frame: 10 minutes, 1 hour, and 2 hours after eye drop instillation
Post-eye drop instillation, the LipiView interferometer will be used to measure the thickness of the tear lipid layer on both eyes.
Tear thinning rate (%/sec)
Time frame: 10 minutes, 1 hour, and 2 hours after eye drop instillation
Post-eye drop instillation, the EasyTear VIEW+ tearscope will be used to measure the rate of tear aqueous thinning on both eyes.
1 secondary outcome
Ocular Sensation Survey
Time frame: 10 minutes, 1 hour, and 2 hours after eye drop instillation
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 26 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TRYPTYR Eye Drops and Purilens Plus Non-Preserved Saline Eye Drops in people with Dry Eye, run by University of California, Berkeley at 1 site in United States.
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 7 inclusion and 16 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: opening soon, as of the sponsor's last update on 26 Oct 2026. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Contact Meng C Lin, OD, PhD (510-643-9252, mlin@berkeley.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear lipid layer thickness (nm) (time frame: 10 minutes, 1 hour, and 2 hours after eye drop instillation). The study lists 2 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 26 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.