Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04819269 |
Recruitment Status :
Recruiting
First Posted : March 26, 2021
Last Update Posted : June 24, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dry Eye Disease Sjögren Syndrome | Drug: Tivanisiran sodium ophthalmic solution Drug: Vehicle ophthalmic solution | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome |
Actual Study Start Date : | May 25, 2021 |
Estimated Primary Completion Date : | December 20, 2022 |
Estimated Study Completion Date : | February 20, 2023 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Tivanisiran sodium ophthalmic solution |
Drug: Tivanisiran sodium ophthalmic solution
1 drop in the affected eye(s) once daily |
Placebo Comparator: Vehicle ophthalmic solution |
Drug: Vehicle ophthalmic solution
1 drop in the affected eye(s) once daily |
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04819269
United States, Alabama | |
Sylentis Investigative Site | Recruiting |
Dothan, Alabama, United States, 36301 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
United States, Arizona | |
Sylentis Investigative Site | Terminated |
Scottsdale, Arizona, United States, 85254 | |
United States, California | |
Sylentis Investigative Site | Recruiting |
Glendale, California, United States, 91204 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
Sylentis Investigative Site | Recruiting |
Los Angeles, California, United States, 90013 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
Sylentis Investigative Site | Recruiting |
Newport Beach, California, United States, 92663 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
Sylentis Investigative Site | Recruiting |
Rancho Cordova, California, United States, 95670 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
Sylentis Investigative Site | Terminated |
San Diego, California, United States, 92122 | |
Sylentis Investigative Site | Recruiting |
Torrance, California, United States, 90505 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
United States, Colorado | |
Sylentis Investigative Site | Recruiting |
Aurora, Colorado, United States, 80045 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
Sylentis Investigative Site | Recruiting |
Colorado Springs, Colorado, United States, 80907 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
Sylentis Investigative Site | Recruiting |
Littleton, Colorado, United States, 80120 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
United States, Florida | |
Sylentis Investigative Site | Recruiting |
Jacksonville, Florida, United States, 32256 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
Sylentis Investigative Site | Recruiting |
Largo, Florida, United States, 33773 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
Sylentis Investigative Site | Not yet recruiting |
Miami, Florida, United States, 33136 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
Sylentis Investigative Site | Recruiting |
Ormond Beach, Florida, United States, 32174 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
Sylentis Investigative Site | Recruiting |
Tampa, Florida, United States, 33603 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
United States, Georgia | |
Sylentis Investigative Site | Recruiting |
Atlanta, Georgia, United States, 30339 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
Sylentis Investigative Site | Not yet recruiting |
Morrow, Georgia, United States, 30260 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
United States, Indiana | |
Sylentis Investigative Site | Recruiting |
Carmel, Indiana, United States, 46290 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
United States, Massachusetts | |
Sylentis Investigative Site | Recruiting |
Waltham, Massachusetts, United States, 02451 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
United States, Michigan | |
Sylentis Investigative Site | Recruiting |
Ypsilanti, Michigan, United States, 48197 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
United States, Missouri | |
Sylentis Investigative Site | Recruiting |
Kansas City, Missouri, United States, 64111 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
Sylentis Investigative Site | Recruiting |
Saint Louis, Missouri, United States, 63131 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
Sylentis Investigative Site | Recruiting |
Washington, Missouri, United States, 63090 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
United States, North Carolina | |
Sylentis Investigative Site | Recruiting |
Asheville, North Carolina, United States, 28803 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
Sylentis Investigative Site | Recruiting |
High Point, North Carolina, United States, 27262 | |
Contact: egulatory Affairs Department info@sylentis.com | |
United States, North Dakota | |
Sylentis Investigative Site | Recruiting |
Fargo, North Dakota, United States, 58103 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
United States, Ohio | |
Sylentis Investigative Site | Recruiting |
Cleveland, Ohio, United States, 44115 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
Sylentis Investigative Site | Recruiting |
Columbus, Ohio, United States, 43215 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
United States, Pennsylvania | |
Sylentis Investigative Site | Recruiting |
Cranberry Township, Pennsylvania, United States, 16066 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
United States, South Dakota | |
Sylentis Investigative Site | Recruiting |
Rapid City, South Dakota, United States, 57701 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
United States, Tennessee | |
Sylentis Investigative Site | Terminated |
Memphis, Tennessee, United States, 38103 | |
Sylentis Investigative Site | Not yet recruiting |
Nashville, Tennessee, United States, 37215 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
United States, Texas | |
Sylentis Investigative Site | Recruiting |
El Paso, Texas, United States, 79902 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
Sylentis Investigative Site | Not yet recruiting |
Houston, Texas, United States, 77030 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
Sylentis Investigative Site | Recruiting |
Houston, Texas, United States, 77034 | |
Contact: Regulatory Affairs Department info@sylentis.com | |
United States, Virginia | |
Sylentis Investigative Site | Recruiting |
Falls Church, Virginia, United States, 22042 | |
Contact: Regulatory Affairs Department info@sylentis.com |
Responsible Party: | Sylentis, S.A. |
ClinicalTrials.gov Identifier: | NCT04819269 |
Other Study ID Numbers: |
SYL1001_V |
First Posted: | March 26, 2021 Key Record Dates |
Last Update Posted: | June 24, 2022 |
Last Verified: | June 2022 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
oligonucleotide siRNA keratoconjunctivitis sicca SYL1001 |
Sjogren's Syndrome Dry Eye Syndromes Keratoconjunctivitis Sicca Eye Diseases Syndrome Disease Pathologic Processes Lacrimal Apparatus Diseases Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases Arthritis, Rheumatoid |
Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Xerostomia Salivary Gland Diseases Mouth Diseases Stomatognathic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Pharmaceutical Solutions Ophthalmic Solutions |