Dry Eye DiseasePhase 3NCT04819269
Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
A Phase 3 study testing Tivanisiran sodium ophthalmic solution in people with Dry Eye Disease and Sjögren Syndrome, run by Sylentis, S.A. at 46 sites in 2 countries.
Trial 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 eye disease (DED) due to Sjögren's Syndrome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease, Sjögren Syndrome
- What is being tested?
- Tivanisiran sodium ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 203 participants
- Where
- 46 sitesin 2 countries
- Study dates
- 25 May 2021to 11 Dec 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
46 sites in 2 countries.
46 sites in 2 countries
United States39 sites
Sylentis Investigative Site
Asheville, North Carolina, 28803
Sylentis Investigative Site
Atlanta, Georgia, 30339
Sylentis Investigative Site
Aurora, Colorado, 80045
Sylentis Investigative Site
Birmingham, Alabama, 35294
Sylentis Investigative Site
Carmel, Indiana, 46290
Sylentis Investigative Site
Cleveland, Ohio, 44115
Sylentis Investigative Site
Colorado Springs, Colorado, 80907
Sylentis Investigative Site
Columbus, Ohio, 43215
Sylentis Investigative Site
Cranberry Township, Pennsylvania, 16066
Sylentis Investigative Site
Dothan, Alabama, 36301
Sylentis Investigative Site
El Paso, Texas, 79902
Sylentis Investigative Site
Falls Church, Virginia, 22042
Sylentis Investigative Site
Fargo, North Dakota, 58103
Sylentis Investigative Site
Garden Grove, California, 92843
Sylentis Investigative Site
Glendale, California, 91204
Sylentis Investigative Site
High Point, North Carolina, 27262
Sylentis Investigative Site
Houston, Texas, 77030
Sylentis Investigative Site
Houston, Texas, 77034
Sylentis Investigative Site
Jacksonville, Florida, 32256
Sylentis Investigative Site
Kansas City, Missouri, 64111
Sylentis Investigative Site
Largo, Florida, 33773
Sylentis Investigative Site
Littleton, Colorado, 80120
Sylentis Investigative Site
Los Angeles, California, 90013
Sylentis Investigative Site
Memphis, Tennessee, 38103
Sylentis Investigative Site
Miami, Florida, 33136
Sylentis Investigative Site
Morrow, Georgia, 30260
Sylentis Investigative Site
Nashville, Tennessee, 37215
Sylentis Investigative Site
Newport Beach, California, 92663
Sylentis Investigative Site
Ormond Beach, Florida, 32174
Sylentis Investigative Site
Rancho Cordova, California, 95670
Sylentis Investigative Site
Rapid City, South Dakota, 57701
Sylentis Investigative Site
San Diego, California, 92122
Sylentis Investigative Site
Scottsdale, Arizona, 85254
Sylentis Investigative Site
St Louis, Missouri, 63131
Sylentis Investigative Site
Tampa, Florida, 33603
Sylentis Investigative Site
Torrance, California, 90505
Sylentis Investigative Site
Waltham, Massachusetts, 02451
Sylentis Investigative Site
Washington, Missouri, 63090
Sylentis Investigative Site
Ypsilanti, Michigan, 48197
Spain7 sites
Sylentis Investigative Site
Barcelona, 08022
Sylentis Investigative Site
Madrid, 28034
Sylentis Investigative Site
Madrid, 28040
Sylentis Investigative Site
Pamplona, Navarre, 31008
Sylentis Investigative Site
Seville, 41009
Sylentis Investigative Sites
Valladolid, 47003
Sylentis Investigative Site
Zaragoza, 50004
About this study
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.
- Conditions
- Dry Eye Disease, Sjögren Syndrome
- Being tested
- Tivanisiran sodium ophthalmic solution, Vehicle ophthalmic solution
- Keywords
- oligonucleotide, siRNA, keratoconjunctivitis sicca, SYL1001
- Medical subject headings
- Dry Eye Syndromes, Sjogren's Syndrome, Keratoconjunctivitis Sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tivanisiran sodium ophthalmic solutionDrug
1 drop in the affected eye(s) once daily
Vehicle ophthalmic solutionDrug
1 drop in the affected eye(s) once daily
| Study group | Role | What they receive |
|---|---|---|
| Tivanisiran sodium ophthalmic solution | Active comparator | Not described Receives: Drug: Tivanisiran sodium ophthalmic solution |
| Vehicle ophthalmic solution | Placebo comparator | Not described Receives: Drug: Vehicle ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening.
Measured: 85 days
Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening.
Measured: 85 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start25 May 2021
- Primary completion11 Dec 2023
- Study completion11 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sylentis, S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819269
- Sponsor's protocol ID
- SYL1001_V
- Status last verified
- Feb 2024
- First submitted
- 24 Mar 2021
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
- ClinicalTrials.gov ID
- NCT04819269
- Acronym / sponsor ID
- SYL1001_V
- Conditions
- Dry Eye Disease, Sjögren Syndrome
- Keywords
- oligonucleotide, siRNA, keratoconjunctivitis sicca, SYL1001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Sylentis, S.A.Industry (pharma, biotech, devices)
- Study start
- 25 May 2021 (actual)
- Primary completion
- 11 Dec 2023 (actual)
- Study completion
- 11 Dec 2023 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tivanisiran sodium ophthalmic solution | Active comparator | Drug: Tivanisiran sodium ophthalmic solution |
| Vehicle ophthalmic solution | Placebo comparator | Drug: Vehicle ophthalmic solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tivanisiran sodium ophthalmic solution1 drop in the affected eye(s) once daily | Drug | Tivanisiran sodium ophthalmic solution |
| Vehicle ophthalmic solution1 drop in the affected eye(s) once daily | Drug | Vehicle ophthalmic solution |
Primary outcome
Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening.
Time frame: 85 days
Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening.
Time frame: 85 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
46 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tivanisiran sodium ophthalmic solution in people with Dry Eye Disease and Sjögren Syndrome, run by Sylentis, S.A. at 46 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in United States, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening. (time frame: 85 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.