TRYPTYR as a Treatment for Patients With Dry Eye Disease (DED)
Recruiting
Phase 4
Interventional Study
Dry Eye Disease (DED)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 50 (estimated)
- Sponsor
- NYU Langone Health · Other
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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)…
Trial Locations
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Eligibility Criteria
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 …
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