TRYPTYR eye drops for dry eye disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 4 interventional trial evaluates the effectiveness of Acoltremon ophthalmic solution 0.003% (TRYPTYR) for Dry Eye Disease. The primary outcome is change in the Ocular Surface Disease Index (OSDI) from baseline to week 2, with co-primary outcomes including changes in corneal and conjunctival NEI staining scores at about one month. Eligible participants are adults with confirmed DED and measurable tear film and ocular surface abnormalities. Participants will receive TRYPTYR and will be assessed at multiple visits to monitor safety and efficacy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Adults (18 and older)
2. Ability to provide informed consent and to understand the study procedures
3. Patients diagnosed with dry eye disease
4. Presence of dry eye symptoms determined by a validated questionnaire (OSDI- Attachment 1) with scores above a specified threshold AND
5. Tear film break-up time (TBUT) below a set value (less than 8 seconds)
6. Schirmer test (w/o drops) value below a set cut-off (less than 10 mm)
7. Positive findings on ocular surface staining (NEI \>/equal 3)
8. Positive conjunctival staining (NEI \>4)
9. Moderate meibomian gland dysfunction (MGD)

Exclusion Criteria:

* 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

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Giacomina Massaro-Giordano, MD — NYU Langone Health
• Study coordinator: Jamika Singleton-Garvin
• Email: Jamika.Singleton-Garvin@nyulangone.org
• Phone: 929-455-5522

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.