Dry Eye DiseasePhase 3FYDESNCT05310422
Safety Study of Tivanisiran to Treat Dry Eye
A Phase 3 study testing Tivanisiran sodium ophthalmic solution in people with Dry Eye Disease, run by Sylentis, S.A. at 25 sites in United States.
Trial summary
This study will examine the safety of tivanisiran sodium eye drops versus vehicle when dosed once daily for 1 year in subjects with signs and symptoms of dry eye disease (DED). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease
- What is being tested?
- Tivanisiran sodium ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 301 participants
- Where
- 25 sitesUnited States
- Study dates
- 24 Mar 2022to 11 Oct 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Be at least 18 years of age
- 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
Who cannot join
- Pregnant or breast feeding females with a positive pregnancy test
- Women of childbearing potential not willing to use a medically acceptable contraceptive method
- Currently participating or has participated in another clinical trial within the 2 months prior to inclusion
- Current, previous chronic or recurrent medical condition that, according to the investigator, might impact on the study
- Any concomitant treatment or prior ocular procedure or surgery in either eye or alteration of the dose of systemic medications that could interfere in the trial
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Sylentis Investigative Site
Asheville, North Carolina, 28803
Sylentis Investigative Site
Austin, Texas, 78731
Sylentis Investigative Site
Chandler, Arizona, 85021
Sylentis Investigative Site
Cranberry Township, Pennsylvania, 16066
FYDES Investigative Site
Delray Beach, Florida, 33484
FYDES Investigative Site
El Paso, Texas, 79902
Sylentis Investigative Site
Fraser, Michigan, 48026
Sylentis Investigative Site
Garner, North Carolina, 27529
FYDES Investigative Site
Glendale, California, 91204
Sylentis Investigative Site
Hemet, California, 92545
FYDES Investigative Site
Jacksonville, Florida, 32256
Sylentis Investigative Site
Kansas City, Missouri, 64111
Sylentis Investigative Site
Largo, Florida, 33773
Sylentis Investigative Site
Los Angeles, California, 85032
Sylentis Investigative Site
Memphis, Tennessee, 38119
Sylentis Investigative Site
Morrow, Georgia, 30260
Sylentis Investigative Site
Murrieta, California, 92562
Sylentis Investigative Site
Newport Beach, California, 92663
Sylentis Investigative Site
Phoenix, Arizona, 85032
Sylentis Investigative Site
Rapid City, South Dakota, 57701
Sylentis Investigative Site
Rochester, New York, 14618
Sylentis Investigative Site
San Antonio, Texas, 78215
Sylentis Investigative Site
San Antonio, Texas, 78230
FYDES Investigative Site
St Louis, Missouri, 63131
Sylentis Investigative Site
Washington, Missouri, 63090
About this study
This study will examine the safety of tivanisiran sodium eye drops versus vehicle when dosed once daily for 1 year in subjects with signs and symptoms of dry eye disease (DED).
- Conditions
- Dry Eye Disease
- Being tested
- Tivanisiran sodium ophthalmic solution, Vehicle ophthalmic solution
- Keywords
- siRNA, oligonucleotide, keratoconjunctivitis sicca, SYL1001
- Medical subject headings
- Dry Eye Syndromes, 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 | Experimental | 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.
Number and Percentage of Subjects With Ocular and Non-ocular Treatment Emergent Adverse Events (TEAEs) for 1 Year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study start24 Mar 2022
- Primary completion11 Oct 2023
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 301 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
- NCT05310422
- Sponsor's protocol ID
- SYL1001_VI
- Acronym
- FYDES
- Status last verified
- Sep 2026
- First submitted
- 25 Mar 2022
- Last updated
- 9 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.
PubMed 36729473
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Study of Tivanisiran to Treat Dry Eye
- ClinicalTrials.gov ID
- NCT05310422
- Acronym / sponsor ID
- FYDES / SYL1001_VI
- Conditions
- Dry Eye Disease
- Keywords
- siRNA, oligonucleotide, keratoconjunctivitis sicca, SYL1001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 301 participants (actual)
- Lead sponsor
- Sylentis, S.A.Industry (pharma, biotech, devices)
- Study start
- 24 Mar 2022 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Posted 9 Sep 2026
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 safety of tivanisiran sodium eye drops versus vehicle when dosed once daily for 1 year in subjects with signs and symptoms of dry eye disease (DED).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tivanisiran sodium ophthalmic solution | Experimental | 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 (3 listed)
- Be at least 18 years of age
- 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
Key exclusion criteria (5 listed)
- Pregnant or breast feeding females with a positive pregnancy test
- Women of childbearing potential not willing to use a medically acceptable contraceptive method
- Currently participating or has participated in another clinical trial within the 2 months prior to inclusion
- Current, previous chronic or recurrent medical condition that, according to the investigator, might impact on the study
- Any concomitant treatment or prior ocular procedure or surgery in either eye or alteration of the dose of systemic medications that could interfere in the trial
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
Number and Percentage of Subjects With Ocular and Non-ocular Treatment Emergent Adverse Events (TEAEs) for 1 Year
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36729473Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.
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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.
25 sites in 1 country: 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, run by Sylentis, S.A. at 25 sites in United States.
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 3 inclusion and 5 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. 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?
Yes. Results are posted in the registry (first posted 9 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number and Percentage of Subjects With Ocular and Non-ocular Treatment Emergent Adverse Events (TEAEs) for 1 Year (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05310422, which also lists 1 linked publication.
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 9 Sep 2026.