TRYPTYR for Dry Eye Disease

This study is testing a new eye drop called TRYPTYR (Acoltremon ophthalmic solution 0.003%) to see how well it treats Dry Eye Disease (DED). Researchers want to find out if TRYPTYR can improve your dry eye symptoms and the health of your eye's surface. You might be able to join if you are an adult (18 or older) with a diagnosis of dry eye disease, have certain dry eye symptoms, and a specific tear film break-up time (TBUT) score. The study will measure changes in your Ocular Surface Disease Index (OSDI) score after two weeks, and changes in your cornea and conjunctiva (the clear membrane covering the white part of your eye) after one month. The study plans to enroll 50 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 50 adult participants.
What's involved
You would administer TRYPTYR eye drops in each eye twice daily for 30 days. Your dry eye symptoms and eye health will be checked at the start, after two weeks, and after one month.
Compensation
Not stated in the trial record.
Follow-up
Your eye health will be assessed at 1 month after starting the treatment.

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NCT07732010

TRYPTYR as a Treatment for Patients With Dry Eye Disease (DED)

Recruiting
PHASE4Ages 18+InterventionalTreatment
NYU Langone Health
~50 participants
Updated 2026-07-28 on ClinicalTrials.gov
What's tested:TRYPTYR (Acoltremon ophthalmic solution 0.003%)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in ocular surface disease index (OSDI) Score
Measured over Baseline, Week 2
+2 more outcomes measured
Dry Eye Disease (DED)
1 sites across 1 states
New York1
  • Giacomina Massaro-Giordano, MD · PRINCIPAL_INVESTIGATOR · NYU Langone Health

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Eligibility criteria

Exclusion

History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, interfere with the interpretation of the study results or subject safety
History of ocular surgery within 3 months prior to the Screening visit, including punctal cautery, corneal refractive, or anterior segment surgeries that affect corneal sensitivity (e.g., cataract surgery or any surgery involving limbal or corneal incision) or lid surgery
Have had a corneal transplant in either or both eyes
Patients with current steroid use
Pregnancy
  • Change in ocular surface disease index (OSDI) ScoreBaseline, Week 2

    The Ocular Surface Disease Index (OSDI) is a 12-question screening tool used to measure the severity of dry eye disease and how it affects vision. Scores range from 0 to 100, with higher numbers indicating more severe symptoms.

  • Change in National Eye Institute (NEI) scale of the corneaBaseline, 1 Month

    The NEI scale of the cornea is a standardized system used to grade corneal fluorescein staining. It evaluates punctate epithelial erosions (staining) across five specific corneal zones (superior, inferior, nasal, temporal, and central) to yield a total severity score. Each of the 5 zones is graded on an integer scale from 0 (No staining) to 3 (Severe or confluent staining). Total scores of 0-5 typically indicate mild surface disease, 6-10 represent moderate disease, and 11-15 indicate severe ocular surface disease.

  • Change in NEI scale of the conjunctivaBaseline, 1 Month

    The National Eye Institute (NEI) scale of the conjunctiva evaluates the ocular surface by dividing the conjunctiva into six specific areas for evaluation to grade staining. Each of these six regions is graded individually on a 0 (none) to 3 (severe) scale. By adding the scores of all six regions, the conjunctiva yields a total score ranging from 0 to 18. Low scores represent a healthy or mildly compromised ocular surface, whereas high scores indicate severe surface disease like dry eye