Status:
COMPLETED
Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
Lead Sponsor:
Sylentis, S.A.
Conditions:
Dry Eye Disease
Sjögren Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study will examine the efficacy and safety of tivanisiran sodium eye drops versus vehicle after a 2-week run-in phase when dosed once daily for 3 months in subjects with signs and symptoms of dry...
Eligibility Criteria
Inclusion
- Subject is a male or a female aged ≥ 18 years
- Have given their written consent to participate in the study
- Use of artificial tears (AT), autologous serum or specific dry eye medications during the last 6 months prior to the selection
- Willing to not use AT or autologous serum for the study duration
- VAS scale for Dry Eye Symptom Score ≥ 40
- Total CFS ≥ 5
- Schirmer's test with anesthesia \< 10 mm/5min
- Patients with Sjögren Syndrome
Exclusion
- Any concomitant treatment or prior ocular procedure or surgery, or alteration of the dose of systemic medications at the time of entry into the study
- Use of contact lenses during the study
- Significant Eye diseases according to investigator's opinion
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 11 2023
Estimated Enrollment :
203 Patients enrolled
Trial Details
Trial ID
NCT04819269
Start Date
May 25 2021
End Date
December 11 2023
Last Update
February 20 2024
Active Locations (46)
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1
Sylentis Investigative Site
Birmingham, Alabama, United States, 35294
2
Sylentis Investigative Site
Dothan, Alabama, United States, 36301
3
Sylentis Investigative Site
Scottsdale, Arizona, United States, 85254
4
Sylentis Investigative Site
Garden Grove, California, United States, 92843