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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 February 2024 |
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Main ID: |
NCT04819269 |
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Date of registration:
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24/03/2021 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
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Scientific title:
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Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome |
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Date of first enrolment:
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May 25, 2021 |
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Target sample size:
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203 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT04819269 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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Spain
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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 Criteria:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dry Eye Disease
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Sjögren Syndrome
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Intervention(s)
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Drug: Vehicle ophthalmic solution
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Drug: Tivanisiran sodium ophthalmic solution
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Primary Outcome(s)
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Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening.
[Time Frame: 85 days]
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Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening.
[Time Frame: 85 days]
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Secondary ID(s)
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SYL1001_V
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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