How TRYPTYR affects quality of life and the ability to work for people with dry eye

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This one-month, three-visit interventional study enrolls adults with chronic symptomatic dry eye and reduced tear production at three U.S. eye clinics. Participants will receive Acoltremon 0.003% (TRYPTYR) and be evaluated at baseline and two follow-up visits for symptoms (Eye Dryness VAS, SANDE), tear production (Schirmer test), and work-related quality of life (IDEEL Work domain). Key eligibility includes a history of dry eye for at least six months, abnormal Schirmer scores, and current symptoms despite prior therapy such as Restasis. The study focuses on patient-centered outcomes to determine whether the TRPM8 agonist improves daily functioning and tear production in a real-world patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults ≥18 years of age.
* Have a history of DED for at least the past 6 months.
* Are currently using Restasis as directed by their eye care provider for ≥1 month.
* Participant intends to stop Restasis in the near future because and expressed dissatisfaction with effectiveness of Restasis in reducing dry eye symptoms..
* Are symptomatic as determined with the Eye Dryness visual analog scale (VAS) (Score ≥50), SPEED (≥7), and have an abnormal Schirmer test score \[≥2 to \<10 mm/5 min\]) at Screening/Baseline.
* Have corrected distance visual acuity of 20/100 or better.
* Willing to discontinue contact lens wear throughout the study.

Exclusion Criteria:

* Have a systemic health condition that is known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
* Have a history of ocular surgery within the past 12 months.
* Have a history of severe ocular trauma, active ocular infection or inflammation that is not dry eye related.
* Punctal plugs in place for \< 3 months and/or Lacrifill in place for \> 5 months.
* Have ever used Accutane or are currently using ocular medications (must washout from all dry eye medications/treatments at least 1 week before entry, except for Restasis).
* Use of artificial tears within 2 hours prior to the baseline visit or during the study.
* Are pregnant or breast feeding.
* Have had a physical meibomian gland treatment withing 1 month of enrollment.
* 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.

Where it's running

• Kannar Eye Care
  Pittsburg, Kansas, United States Recruiting
• Complete Eye Care of Medina
  Medina, Minnesota, United States Recruiting
• The Southern College of Optometry
  Memphis, Tennessee, United States Recruiting

Study contacts

• Study coordinator: Chris Lievens, OD
• Email: clievens@sco.edu
• Phone: 901-722-3330

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.