Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

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ClinicalTrials.gov Identifier: NCT04819269

Recruitment Status : Recruiting

First Posted : March 26, 2021

Last Update Posted : May 28, 2021

See Contacts and Locations

Sponsor:

Information provided by (Responsible Party):

Sylentis, S.A.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Dry Eye Disease Sjögren Syndrome	Drug: Tivanisiran sodium ophthalmic solution Drug: Vehicle ophthalmic solution	Phase 3

Study Design

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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 :	April 20, 2022
Estimated Study Completion Date :	June 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Sjögren syndrome

MedlinePlus related topics: Sjogren's Syndrome

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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United States, Arizona
Sylentis Investigative Site	Recruiting
Scottsdale, Arizona, United States, 85254
Contact: Regulatory Affairs Department info@sylentis.com
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	Recruiting
San Diego, California, United States, 92122
Contact: Regulatory Affairs Department info@sylentis.com
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
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
United States, Indiana
Sylentis Investigative Site	Recruiting
Carmel, Indiana, United States, 46290
Contact: Regulatory Affairs Department info@sylentis.com
United States, Kentucky
Sylentis Investigative Site	Recruiting
Louisville, Kentucky, United States, 40220
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, Missouri
Sylentis Investigative Site	Recruiting
Kansas City, Missouri, United States, 64111
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, New York
Sylentis Investigative Site	Recruiting
Slingerlands, New York, United States, 12159
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
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	Not yet recruiting
Memphis, Tennessee, United States, 38104
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	Recruiting
Houston, Texas, United States, 77034
Contact: Regulatory Affairs Technician info@sylentis.com

Sponsors and Collaborators

Sylentis, S.A.

More Information

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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:	May 28, 2021
Last Verified:	May 2021

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Sylentis, S.A.:


oligonucleotide siRNA keratoconjunctivitis sicca SYL1001

Additional relevant MeSH terms:

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Sjogren's Syndrome Keratoconjunctivitis Sicca Dry Eye Syndromes Eye Diseases Syndrome Disease Pathologic Processes Keratoconjunctivitis Conjunctivitis Conjunctival Diseases Keratitis Corneal Diseases Lacrimal Apparatus 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

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