NCT04819269CompletedPhase 3
Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
Source: ClinicalTrials.gov · Last updated 20 Feb 2024
Brief summary (registry, in English)
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 eye disease (DED) due to Sjögren's Syndrome.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 203 (actual)
- First submitted
- 24 Mar 2021
- Start date
- 25 May 2021
- Primary completion date
- 11 Dec 2023
- Lead sponsor
- Sylentis, S.A.
- Diseases
- Sjögren's disease
- NCT number
- NCT04819269
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 203
- From 25 May 2021 to the primary completion date, 11 Dec 2023
- 44 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Significant Eye diseases according to investigator's opinion
Other
- Use of contact lenses during the study
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (44)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.