Actively Recruiting
Evaluating the Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work
Led by Southern College of Optometry · Updated on 2025-12-05
40
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Dry eye disease (DED) is a common condition that affects both working-age adults and the elderly, causing symptoms like dryness and burning, and signs such as decreased tear production or increased tear evaporation. Diagnosing and treating DED can be challenging because symptoms and signs do not always match. This research aims to study a new treatment called Acoltremon 0.003% (TRYPTYR), recently approved by the FDA, to see if it can improve the quality of life and work ability of people suffering from DED by stimulating tear production through activating specific nerve receptors. Participants who qualify will receive TRYPTYR during the 1-month study, which includes three visits. TRYPTYR acts as a TRPM8 receptor agonist that stimulates cold thermoreceptors on the eye's nerves to increase tear production. The study focuses on assessing the effect of this medication on patients experiencing dry eye symptoms, with dosing and administration details provided during the visits. During the study, adults aged 18 to 75 years with diagnosed DED lasting at least six months and currently symptomatic will be assessed through visual analog scales, tear tests, and quality of life questionnaires related to work. Researchers will monitor changes in work-related quality of life scores at 14 and 28 days. Participants will also undergo eye exams, vision tests, and symptom assessments to track safety and treatment effects throughout the study.
CONDITIONS
Brief Title
Impact of TRYPTYR on a Patient's Quality of Life and Ability to Perform Work
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years of age or older
- History of dry eye disease for at least 6 months
- Currently using Restasis as directed for at least 1 month
- Planning to stop Restasis soon due to dissatisfaction with its effectiveness
- Symptomatic with Eye Dryness visual analog scale (VAS) score of 50 or higher and SPEED score of 7 or higher
- Abnormal Schirmer test score between 2 and less than 10 mm/5 minutes at screening
- Corrected distance visual acuity of 20/100 or better
- Willing to stop contact lens wear throughout the study
You will not qualify if you...
- Systemic health conditions that affect tear film physiology, such as Sjögren's syndrome
- History of ocular surgery within the past 12 months
- History of severe ocular trauma, active ocular infection, or inflammation unrelated to dry eye
- Punctal plugs in place for less than 3 months or Lacrifill in place for more than 5 months
- Use or history of Accutane or current use of ocular medications other than Restasis without proper washout
- Use of artificial tears within 2 hours before baseline or during the study
- Pregnant or breastfeeding
- Physical meibomian gland treatment within 1 month before enrollment
- Any condition or situation that may increase risk, confound results, or interfere with study participation as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants receive TRYPTYR (Acoltremon 0.003%) to evaluate its effectiveness in alleviating symptoms associated with dry eye disease.
Baseline visit and 1 follow-up visit at Day 14
Trial Site Locations
Total: 3 locations
1
Kannar Eye Care
Pittsburg, Kansas, United States, 66762
Actively Recruiting
2
Complete Eye Care of Medina
Medina, Minnesota, United States, 55340
Actively Recruiting
3
The Southern College of Optometry
Memphis, Tennessee, United States, 38104
Actively Recruiting
Research Team
C
Chris Lievens, OD
Q
Quentin Franklin, BS, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here