How TRYPTYR affects quality of life and the ability to work for people with dry eye
Evaluating the Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work
This one-month test will see if TRYPTYR (acoltremon) eye drops help adults with chronic dry eye produce more tears, reduce symptoms, and improve their ability to do work.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Southern College of Optometry Academic / other |
| Locations | 3 sites (Pittsburg, Kansas and 2 other locations) |
| Trial ID | NCT07266948 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with at least six months of symptomatic dry eye, abnormal Schirmer test (<10 mm/5 min and ≥2 mm), significant work-related quality-of-life impact, corrected visual acuity meeting the protocol, currently using Restasis but planning to stop, and willing to avoid contact lenses are ideal candidates.
Not a fit: Patients with systemic diseases that alter tear physiology (e.g., Sjögren's), recent ocular surgery, severe ocular trauma, active ocular infection or non-dry-eye inflammation, or those unable to discontinue contact lenses or certain medications are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, TRYPTYR could increase tear production, reduce dry eye symptoms, and help people perform work tasks more comfortably.
How similar studies have performed: Acoltremon (acoltremon 0.003%) is a recently FDA-approved TRPM8 agonist and prior clinical work has shown improvements in tear production and symptom scores such as SANDE, so the mechanism has supporting data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Pittsburg, Kansas and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.