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

Phase 4RecruitingNCT07732010

NYU Langone Health50 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dry Eye Disease (DED)

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

NYU Langone Health

New York, New York, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: Baseline, 1 Month

Central Contacts

Jamika Singleton-Garvin

CONTACT

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

Data from ClinicalTrials.gov

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