TRYPTYR as a Treatment for Patients With Dry Eye Disease (DED)
NCT07732010 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2026-07-28
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
- 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.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Giacomina Massaro-Giordano, MD · NYU Langone Health
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-06
- Primary Completion
- 2027-04-20
- Completion
- 2027-05-25
- FDA Drug
- Yes
Countries
- United States
Study Locations
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