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Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

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
Sponsor:
Information provided by (Responsible Party):
Sylentis, S.A.

Study Description
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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 : December 20, 2022
Estimated Study Completion Date : February 20, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening. [ Time Frame: 85 days ]
  2. Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening. [ Time Frame: 85 days ]

Eligibility Criteria
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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
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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, 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   
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: June 24, 2022
Last Verified: June 2022

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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
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