Evaluating a New Therapy for Dry Eye in Patients With Sjögren's Syndrome
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorCenter For Sight
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
TRYPTYR (Acoltremon ophthalmic solution 0.003%)
DrugDrop to be instilled before and after endpoint measurement.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Study eyeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from pre-instillation to 3 minutes post-TRYPTYR instillation in study eye unanesthetized Schirmer's test at Visit 1 (baseline)
Unanesthetized Schirmer's test will be measured prior to instillation and then again 3 minutes after instillation of the TRYPTYR. The difference between the 2 measurements will be compared.
Time frame
3 minutesSponsors and contacts
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Source ClinicalTrials.gov