NCT07266948

Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work

Evaluating the Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Southern College of Optometry · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Dry Eye
• Eye Diseases
• Eyes Dry Chronic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-01-31
• Completion: 2026-03-01
• First posted: 2025-12-05
• Last updated: 2025-12-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study