TRYPTYR as a Treatment for Patients With Dry Eye Disease (DED)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TRYPTYR (Acoltremon ophthalmic solution 0.003%).
- Who it may be relevant to
- Registry conditions: Dry Eye Disease (DED). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Single Center Investigator Initiated Trial Using TRYPTYR as a Treatment for Patients With Dry Eye Disease
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).
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]
- Change in National Eye Institute (NEI) scale of the cornea [Time frame: Baseline, 1 Month]
- Change in NEI scale of the conjunctiva [Time frame: Baseline, 1 Month]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- NYU Langone Health — New York
Identifiers
NCT: NCT07732010 · 26-00319