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NCT Number: NCT07732010

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

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).

Recruiting

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Key information

Conditions

Dry Eye Disease (DED) Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

NYU Langone Health

New York, 10016, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

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

Treatment and study plan

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.

Primary outcomes

  1. Change in ocular surface disease index (OSDI) Score

    Time frame: Baseline, 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.

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

    Time frame: Baseline, 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.

  3. Change in NEI scale of the conjunctiva

    Time frame: Baseline, 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

Study contacts

Contact information is provided by the study sponsor or research team.

Jamika Singleton-Garvin

CONTACT

[email protected]

929-455-5522

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

A Single Center Investigator Initiated Trial Using TRYPTYR as a Treatment for Patients With Dry Eye Disease

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 28, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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