A Phase 4 interventional study of Acoltremon in Dry Eye, Eye Diseases and Eyes Dry Chronic, sponsored by Southern College of Optometry. Recruiting at 3 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-12-05.
Sponsored by Southern College of Optometry · Phase 4, Interventional, and Treatment
This 1-month, 3-visit study will be conducted at the Southern College of Optometry (Memphis, TN), Kannarr Eye Care, LLC (Pittsburg, KS) and Complete Eye Care of Medina (Minneapolis, MN). Adults ≥18 years of age who have been diagnosed with DED for at least 6 months and who are currently symptomatic (Eye Dryness VAS Score ≥40) will be recruited. Subjects will have an abnormal Schirmer test of \<10 mm/5 min. Subjects will also be required to score ≤70 on the IDEEL Quality of Life (QoL) Work domain to ensure that their DED symptoms are significantly impacting their ability to do work.9 Subjects will be required to have corrected distance visual acuity of 20/32 (0.2 logMAR) or better.
Dry eye disease (DED) is a prevalent condition that commonly affects patients of working age in addition to the elderly.1-3 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).4 Unfortunately, there is not a perfect correlation between DED signs and symptoms,5 which makes diagnosis and timely treatment challenging. With DED symptoms often being bothersome and there being a lack of universally effective treatment options,6 DED patients are significantly more likely to suffer from a decreased quality of life and a psychological condition such depression.7 Thus, the DED patient population would strongly benefit from new, innovative treatments that are based upon a novel mechanism.
Acoltremon 0.003% (TRYPTYR; Alcon Laboratories; Fort Worth, TX, USA) 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.8 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.8 This drugs subsequently stimulates cold thermoreceptor to increase tear production. While acoltremon 0.003% has been significantly shown to improve tear production and symptoms as measured by the Symptom Assessment in Dry Eye (SANDE) at 14- and 28-days post-treatment, the community currently lacks data related to key measures of quality of life such as one's ability to work and perform daily tasks. Thus, the purpose of this study is to determine if acoltremon 0.003% can significantly improve the quality of life of DED suffers
Exclusion Criteria:
Participants who qualify for the study will be given TRYPTYR to determine if it is able to help alleviate symptoms associated with dry eye disease;
Drug: Acoltremon
Participants will be provided with Acoltremon or TRYPTYR to determine whether or not it is an effective medication to help alleviate symptoms associated with dry eye disease
Mean change from baseline in IDEEL-QoL Work scores at 28 days.
the ideel quality of life questionnaire will be used to determine if there was an improvement in participant quality of life while using tryptyr
Time frame: 1 month
Mean change from baseline in IDEEL-QoL Work scores at 14 days.
the ideel quality of life questionnaire will be used to determine if there was an improvement in participant quality of life while using tryptyr
Time frame: 14 days
Plan to share: Undecided
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Southern College of Optometry