Recruiting

TRYPTYR

Sponsor:

NYU Langone Health

Code:

NCT07732010

Conditions

Dry Eye Disease (DED)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TRYPTYR (Acoltremon ophthalmic solution 0.003%)

Study Details

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)

Study ID

NCT07732010

Start date

Jul 6, 2026

Status verified date

Jul, 2026

Completion date

May 25, 2027

Anticipated

Primary completion date

Apr 20, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Dry Eye Disease

Participants will be treated with the TRYPTYR drug for one month

Interventions

TRYPTYR (Acoltremon ophthalmic solution 0.003%)

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

Primary outcome measure

  • Change in ocular surface disease index (OSDI) Score [ Time Frame: Baseline, Week 2 ]
  • Change in National Eye Institute (NEI) scale of the cornea [ Time Frame: Baseline, 1 Month ]
  • Change in NEI scale of the conjunctiva [ Time Frame: Baseline, 1 Month ]

Central Contacts and Locations

Central contacts

Jamika Singleton-Garvin

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

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • DED
  • TRYPTYR

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-03. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-07-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.