A Phase 4 interventional study of acoltremon 0.003%. in Dry Eye, Evaporative Dry Eye and Evaporative Dry Eye Disease, sponsored by Southern College of Optometry. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-28.
Sponsored by Southern College of Optometry · Phase 4, Interventional, and Treatment
The goal of this clinical trial is to [primary purpose is to learn if accordingly, the purpose of this study is to evaluate the effects of acoltremon in participants with evaporative DED, with a focus on characterizing how symptoms and evaporative DED signs change over the first month of treatment.
[primary hypothesis or outcome measure 1] Change in unanesthetized Schirmer test score between pre-drop at baseline compared to post-drop score on Day 1 Researchers will compare all of the enrolled participants, and everyone will be provided the same treatment.
Participants will • 2. Eye Dryness VAS: A 0-100 Eye Dryness VAS will be completed by the participants.
Meibomian Gland Secretion Score (0-15 scale): The 5 central glands on lower eyelid will be evaluated by the investigator with their finger (each scored 0-3): 0 = normal; 1 = thick/yellow; whitish, particulate; 2 = paste; 3 = none/occluded. The investigator will do their best to grade the same 5 glands each visit
Dry eye disease is a complex and multifactorial condition that impacts a large number of people around the world. Symptoms can often include burning, stinging, soreness or irritation. However clinically it is defined differently which can be described as when patients are experiencing reduced tear production (aqueous-deficient DED), increased tear evaporation (evaporative DED), or both (mixed). While many patients suffer from aqueous-deficient DED, evaporative DED is much more prevalent. Acoltremon 0.003% or TRYPTYR is designed to help stimulate TRPM8 receptors which then coordinates the secretion of aqueous from the lacrimal glands, lipids from the meibomian glands, and mucins from the goblet cells. Therefore, the goal of this study is to see if patients with evaporative dry eye disease will benefit from using Acoltremon 0.003%
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's planned enrollment of 41 is below the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Southern College of Optometry is the lead sponsor of 18 studies on the registry; 10 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) 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.
- 1. Adults ≥18 years of age. 2. Have a history of DED for at least the past 6 months. 3. Has DED as determined by the following in the study eye: TBUT ≤5 seconds plus Schirmer's test ≥5 and ≤20 mm plus a tCFS score ≥4 and ≤11 plus total MGS score ≥3.8 If Schirmer's test only qualifies for one eye, that will be the study eye. If Schirmer's test qualifies for both eyes, the eye with the lower Schirmer score will be the study eye.
4. Symptomatic as defined by Eye Dryness VAS score of ≥40 plus Ocular Surface Disease Index (OSDI) score ≥25 5. Have corrected distance visual acuity of 20/40 or better. 6. Willing to discontinue contact lens wear 24 hours prior to screening visit and throughout the study.
Exclusion Criteria:
1. Have a systemic health condition that is known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
2. Have a history of ocular surgery within the past 6 months. 3. Have a history of severe ocular trauma, active ocular infection or inflammation that is not dry eye related.
4. Punctal plugs in place for \<3 months and/or Lacrifill in place for >5 months.
5. Use of topical , topical cyclosporine, lifitegrast, serum tears, or topical glaucoma medication within the previous 30 days screening and during the study period.
6. Use of artificial tears within 24 hours of screening and during the study period.
7. Use of contact lenses within 30 days prior to screening and during the study period.
8. Are pregnant or breast feeding. 9. Have had a physical meibomian gland treatment withing 1 month of enrollment. 10. Initiated, discontinued, or changed dose of a systemic medication known to cause ocular drying (e.g., antihistamines or tricyclic antidepressants) within 14 days of the screening visit.
11. Have a condition or be in a situation, which in the investigator's opinion, may put the participant at significant risk, may confound the results, or may significantly interfere with their study participation.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will receive the study drug and be instructed on how to dose properly; however the bottles will be deidentified, and they will not know the product they are using to prevent biasing.
Drug: acoltremon 0.003%.
this study seeks to address this gap by investigating the short-term impact of acoltremon 0.003% on both symptoms and key clinical markers of evaporative DED, including tear break up time (TBUT).
Also known as: TRYPTYR
Schirmers strip
Change in unanesthetized Schirmer test score between pre-drop at baseline compared to post-drop score on Day 1
Time frame: baseline compared to post drop day 1
VAS Scores
Change in ocular comfort scores at 1-month compared to pre-treatment as evaluated with the Eye Dryness Visual Analog Scale (VAS).
Time frame: 1 month
VAS Scores
Change in ocular comfort scores at 2 weeks compared to pre-treatment as evaluated with the Eye Dryness Visual Analog Scale (VAS).
Time frame: 2 weeks compared to baseline
Start is estimated for Oct 2026; primary completion for Jul 2027, 8 months later.
Of 84 non-industry phase 4 interventional studies under Dry Eye Syndromes, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 28. This study's planned 8 months is below that.
Counting every sponsor, half of 112 studies reached it within 12 months; a quarter within 5 and three quarters within 23.
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.
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Studies of the drug tested here: Acoltremon
Southern College of Optometry