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

NCT07732010 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 26-00319
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Dry Eye Disease (DED)

Keywords

DED; TRYPTYR

Outcome Measures

Primary Outcomes (3)

• Change in ocular surface disease index (OSDI) Score

  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.

  Baseline, Week 2

• Change in National Eye Institute (NEI) scale of the cornea

  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.

  Baseline, 1 Month

• Change in NEI scale of the conjunctiva

  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

  Baseline, 1 Month

Study Arms (1)

Dry Eye Disease

EXPERIMENTAL

Participants will be treated with the TRYPTYR drug for one month

Drug: TRYPTYR (Acoltremon ophthalmic solution 0.003%)

Interventions

TRYPTYR (Acoltremon ophthalmic solution 0.003%) DRUG

TRYPTYR will be administered one drop in each eye twice daily (once every 12 hours) for 30 days.

Dry Eye Disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Giacomina Massaro-Giordano, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jamika Singleton-Garvin

CONTACT

929-455-5522; Jamika.Singleton-Garvin@nyulangone.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2026
• First Posted: July 28, 2026
• Study Start: July 6, 2026
• Primary Completion (Estimated): April 20, 2027
• Study Completion (Estimated): May 25, 2027
• Last Updated: July 28, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)