RecruitingPhase 4NCT07266948

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

Sponsor

Southern College of Optometry

Enrollment

40 participants

Start Date

Nov 1, 2025

Study Type

INTERVENTIONAL

Conditions

Dry Eye Eye Diseases Eyes Dry Chronic

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.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria7

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 Criteria9

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGAcoltremon

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