NCT07732010 · NYU Langone Health
TRYPTYR as a Treatment for Patients With Dry Eye Disease (DED)
What this study is about
The purpose of this research study is to determine the effectiveness of TRYPTYR as a treatment for Dry Eye Disease. The primary effectiveness variable is change from baseline in the Ocular Surface Disease Index (OSDI) at week 2.
View original scientific description
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).
Interventions
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.
Primary outcome measures
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.
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.
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 28, 2026 · Source of record for eligibility and locations