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Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 4
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Dry Eye Disease 		Participants will be treated with the TRYPTYR drug for one month
  • Drug: TRYPTYR (Acoltremon ophthalmic solution 0.003%)
    TRYPTYR will be administered one drop in each eye twice daily (once every 12 hours) for 30 days.

Recruiting Locations

NYU Langone Health
New York, New York 10016

More Details

Status
Recruiting
Sponsor
NYU Langone Health

Study Contact

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.