Sjogren Syndrome With Keratoconjunctivitis
Conditions
Brief summary
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.
Interventions
Drop to be instilled before and after endpoint measurement.
Sponsors
Center For Sight
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Subjects must fulfill the following conditions to qualify for enrollment into the trial 1. Adults over 18 years old with a diagnosis of dry eye disease (DED) secondary to Sjögren's Syndrome within the past 2 years. 2. History of using or desiring artificial tears for DED symptoms within the past 2 months. 3. 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).
Exclusion criteria
Subjects with any of the following conditions on the eligibility exam may NOT be enrolled into the trial. 1. History of ocular surgery within the past 6 months. 2. Contact lens wear in either eye within 7 days of visit 1 (baseline) or use during study 3. On current topical treatment regimen for less than 3 months or anticipates any change to the regimen during the study period. 4. Use of topical steroid ocular medication or varenicline nasal spray within 4 weeks of baseline or during the study period. 5. Use of artificial tears within 2 hours prior to the baseline or study visit days. 6. Any known allergies to any component of the study drug. 7. Severe, uncontrolled autoimmune disease (e.g., rheumatoid arthritis, lupus). Uncontrolled is at the discretion of the PI. Subjects with severe systemic symptoms will not be included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from pre-instillation to 3 minutes post-TRYPTYR instillation in study eye unanesthetized Schirmer's test at Visit 1 (baseline) | 3 minutes | 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. |
Countries
United States
Contacts
Primary ContactGina Thomas
Outcome results
None listed