TRYPTYR as a Treatment for Patients With Dry Eye Disease (DED) | NCT07732010

NCT07732010

Overview

NCT ID: NCT07732010
Lead Sponsor: NYU Langone HealthOTHER
Official Title: A Single Center Investigator Initiated Trial Using TRYPTYR as a Treatment for Patients With Dry Eye Disease
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)
Interventions

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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

Central Contacts: Jamika Singleton-GarvinContact
Jamika.Singleton-Garvin@nyulangone.org