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New treatment option for Dry Eye Disease (DED)
Official title TRYPTYR as a Treatment for Patients With Dry Eye Disease (DED)
ClinicalTrials.gov ID: NCT07732010
What this study is testing
What is TRYPTYR (Acoltremon ophthalmic solution 0.003%)?
TRYPTYR (Acoltremon ophthalmic solution 0.003%) is an investigational medicine, given as an once-daily, being studied as a potential treatment for dry eye disease (ded).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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)
You likely can't join if
- 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...
- History of ocular surgery within 3 months prior to the Screening visit, including punctal cautery, corneal refractive, or anterior segment surgeries...
- Have had a corneal transplant in either or both eyes
- Patients with current steroid use
- Pregnancy
See the full eligibility 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)
- 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...
- Have had a corneal transplant in either or both eyes
- Patients with current steroid use
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.