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New treatment option for Sjogren Syndrome With Keratoconjunctivitis
Official title Evaluating a New Therapy for Dry Eye in Patients With Sjögren's Syndrome
ClinicalTrials.gov ID: NCT07277257
What this study is testing
What is TRYPTYR (Acoltremon ophthalmic solution 0.003%)?
TRYPTYR (Acoltremon ophthalmic solution 0.003%) is an investigational medicine, being studied as a potential treatment for sjogren syndrome with keratoconjunctivitis.
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
- This study will evaluate the effect of TRYPTYR in patients with Sjögren's syndrome-related dry eye disease. The goal is to determine whether TRYPTYR can improve symptoms and signs of dry eye in this specific patient population.
- 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
- people must fulfill the following conditions to qualify for enrollment into the trial
- Adults over 18 years old with a diagnosis of dry eye disease (DED) secondary to Sjögren's Syndrome within the past 2 years.
- History of using or desiring artificial tears for DED symptoms within the past 2 months.
- Unanesthetized Schirmer's Test (UA ST) score ≥1 and \< 10 mm/5 min and baseline total Corneal Fluorescein Staining (tCFS) score ≥2 and ≤ 15 (National...
You likely can't join if
- people with any of the following conditions on the eligibility exam may NOT be enrolled into the trial.
- History of ocular surgery within the past 6 months.
- Contact lens wear in either eye within 7 days of visit 1 (baseline) or use during study
- On current topical treatment regimen for less than 3 months or anticipates any change to the regimen during the study period.
- Use of topical steroid ocular medication or varenicline nasal spray within 4 weeks of baseline or during the study period.
- Use of artificial tears within 2 hours prior to the baseline or study visit days.
See the full eligibility criteria
- people must fulfill the following conditions to qualify for enrollment into the trial
- Adults over 18 years old with a diagnosis of dry eye disease (DED) secondary to Sjögren's Syndrome within the past 2 years.
- History of using or desiring artificial tears for DED symptoms within the past 2 months.
- Unanesthetized Schirmer's Test (UA ST) score ≥1 and \< 10 mm/5 min and baseline total Corneal Fluorescein Staining (tCFS) score ≥2 and ≤ 15 (National Eye Institute, NEI, grading scale).
- people with any of the following conditions on the eligibility exam may NOT be enrolled into the trial.
- History of ocular surgery within the past 6 months.
- Contact lens wear in either eye within 7 days of visit 1 (baseline) or use during study
- On current topical treatment regimen for less than 3 months or anticipates any change to the regimen during the study period.
- Use of topical steroid ocular medication or varenicline nasal spray within 4 weeks of baseline or during the study period.
- Use of artificial tears within 2 hours prior to the baseline or study visit days.
- Any known allergies to any component of the study drug.
- Severe, uncontrolled autoimmune disease (e.g., rheumatoid arthritis, lupus). Uncontrolled is at the discretion of the PI. people with severe systemic symptoms will not be included.
The study team makes the final eligibility decision.
Where it's taking place
- Venice, Florida, 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 Venice, Florida, 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.