A Phase 4 interventional study of acoltremon 0.003% in Dry Eye, Eye Diseases and Chronic Dry Eye, sponsored by Southern College of Optometry. Not yet recruiting. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Southern College of Optometry · Phase 4, Interventional, and Treatment
Switching to acoltremon 0.003% will significantly improve the signs and symptoms of participants who were being treated with Restasis at 28 days post-treatment compared to baseline. Dry eye disease (DED) is a prevalent condition that commonly affects patients of working age in addition to the elderly. DED is a complex condition that results in ocular symptoms such as dryness and burning and signs such as decreased tear production (aqueous deficient DED) or increased tear evaporation (evaporative DED). Unfortunately, there is not a perfect correlation between DED signs and symptoms, which makes diagnosis and timely treatment challenging.
Acoltremon 0.003% was recently approved by the US Food and Drug Administration (FDA) as the first transient receptor potential melastatin 8 (TRPM8) agonist for the treatment of DED.9, 10 Acoltremon acts by activating TRPM8 receptors expressed on the neurons of the ophthalmic division of the trigeminal nerve, which is the nerve that innervates the cornea and eyelid.9 This drugs subsequently modulates cold thermoreceptor to increase tear production and promote a cooling sensation, which promotes symptomatic relief. While acoltremon 0.003% has been significantly shown to improve the signs and symptoms of DED patient, the community currently lacks data describing how patients who are being treated with Restasis (cyclosporine ophthalmic emulsion), yet are not having their expectations met with the drug, respond to being switched to acoltremon 0.003%. These data are important because they could demonstrate that a DED drug with a different mechanism of action can still be effective when another treatment does not meet the patient's expectations. Thus, the purpose of this study is to determine if acoltremon 0.003% can significantly improve the signs and symptoms of DED suffers who are not currently being successfully treated with Restasis.
Exclusion Criteria:
Switching to acoltremon 0.003% will significantly improve the signs and symptoms of participants who were being treated with Restasis at 28 days post-treatment compared to baseline.
Drug: acoltremon 0.003%
Participants who are using restasis will be switched to acoltremon 0.003%
Change between pre- and post-drop in unanesthetized Schirmer test score on Day 1
schirmers strip wetting/time will be measured between pre and post drop. With quicker wetting with greater voulme being considered better.
Time frame: 1 day
Change in SPEED scores
participants will complete the standardized speed questionnaire at baseline and at 28 days. To determine improvement, lower speed scores are considered better.
Time frame: 28 days
Change in SPEED scores
participants will complete the standardized speed questionnaire at baseline and at 14 days. To determine improvement, lower speed scores are considered better.
Time frame: 14 days
No study locations are listed for this record.
This study is not yet recruiting, as verified in Nov 2025. 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.
Southern College of Optometry