NYU Langone Health
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).
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…
TRYPTYR will be administered one drop in each eye twice daily (once every 12 hours) for 30 days.
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