Health TrialsbyHealthPanel

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

ConditionDry Eye Disease (DED)
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorNYU Langone Health

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Dry Eye DiseaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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
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
3

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NYU Langone Health

Lead sponsor

Source ClinicalTrials.gov
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