What this study is
The purpose of this research study is to determine the effectiveness of TRYPTYR as a treatment for Dry Eye Disease. The primary efficacy variable is change from baseline in the Ocular Surface Disease Index (OSDI) at week 2. The co-primary efficacy variables are change from baseline in the National Eye Institute (NEI) scale of the cornea and NEI scale of the conjunctiva at 1 month (the third visit).
What's being tested
- TRYPTYR (Acoltremon ophthalmic solution 0.003%)
Intervention · DRUG
TRYPTYR will be administered one drop in each eye twice daily (once every 12 hours) for 30 days.
Study details
- Official title
- A Single Center Investigator Initiated Trial Using TRYPTYR as a Treatment for Patients With Dry Eye Disease
- Sponsor
- NYU Langone Health
- Conditions
- Dry Eye Disease (DED)
- Enrolling
- 50 people
- Starts
- 2026-07-06
- Est. completion
- 2027-05-25
- Design
- Open-label, single group, Phase 4
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Adults (18 and older)
- Ability to provide informed consent and to understand the study procedures
- Patients diagnosed with dry eye disease
- Presence of dry eye symptoms determined by a validated questionnaire (OSDI- Attachment 1) with scores above a specified threshold AND; Tear film break-up time (TBUT) below a set value (less than 8 seconds)
- Schirmer test (w/o drops) value below a set cut-off (less than 10 mm)
- Positive findings on ocular surface staining (NEI >/equal 3)
- Positive conjunctival staining (NEI >4)
- Moderate meibomian gland dysfunction (MGD)
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openNYU Langone Health
New York, New York, United States
Recruiting
Study team
Sponsor
NYU Langone Health
Study ID 26-00319
Principal investigator
Giacomina Massaro-Giordano, MD
NYU Langone Health
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.