Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

NCT04819269 | Completed Phase 3 FDA Drug

• 1 other identifier: SYL1001_V
• Study Type: interventional
• Target: 203
• Locations: 2 countries
• Sites: 46

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.

Conditions

Dry Eye Disease; Sjögren Syndrome

Keywords

oligonucleotide; siRNA; keratoconjunctivitis sicca; SYL1001

Outcome Measures

Primary Outcomes (2)

• Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening.

  85 days

• Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening.

  85 days

Study Arms (2)

Tivanisiran sodium ophthalmic solution

ACTIVE COMPARATOR

Drug: Tivanisiran sodium ophthalmic solution

Vehicle ophthalmic solution

PLACEBO COMPARATOR

Drug: Vehicle ophthalmic solution

Interventions

Tivanisiran sodium ophthalmic solution DRUG

1 drop in the affected eye(s) once daily

Tivanisiran sodium ophthalmic solution

Vehicle ophthalmic solution DRUG

1 drop in the affected eye(s) once daily

Vehicle ophthalmic solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sylentis, S.A.: lead

Study Sites (46)

Sylentis Investigative Site

Birmingham, Alabama, 35294, United States

Location

Sylentis Investigative Site

Dothan, Alabama, 36301, United States

Location

Sylentis Investigative Site

Scottsdale, Arizona, 85254, United States

Location

Sylentis Investigative Site

Garden Grove, California, 92843, United States

Location

Sylentis Investigative Site

Glendale, California, 91204, United States

Location

Sylentis Investigative Site

Los Angeles, California, 90013, United States

Location

Sylentis Investigative Site

Newport Beach, California, 92663, United States

Location

Sylentis Investigative Site

Rancho Cordova, California, 95670, United States

Location

Sylentis Investigative Site

San Diego, California, 92122, United States

Location

Sylentis Investigative Site

Torrance, California, 90505, United States

Location

Sylentis Investigative Site

Aurora, Colorado, 80045, United States

Location

Sylentis Investigative Site

Colorado Springs, Colorado, 80907, United States

Location

Sylentis Investigative Site

Littleton, Colorado, 80120, United States

Location

Sylentis Investigative Site

Jacksonville, Florida, 32256, United States

Location

Sylentis Investigative Site

Largo, Florida, 33773, United States

Location

Sylentis Investigative Site

Miami, Florida, 33136, United States

Location

Sylentis Investigative Site

Ormond Beach, Florida, 32174, United States

Location

Sylentis Investigative Site

Tampa, Florida, 33603, United States

Location

Sylentis Investigative Site

Atlanta, Georgia, 30339, United States

Location

Sylentis Investigative Site

Morrow, Georgia, 30260, United States

Location

Sylentis Investigative Site

Carmel, Indiana, 46290, United States

Location

Sylentis Investigative Site

Waltham, Massachusetts, 02451, United States

Location

Sylentis Investigative Site

Ypsilanti, Michigan, 48197, United States

Location

Sylentis Investigative Site

Kansas City, Missouri, 64111, United States

Location

Sylentis Investigative Site

St Louis, Missouri, 63131, United States

Location

Sylentis Investigative Site

Washington, Missouri, 63090, United States

Location

Sylentis Investigative Site

Asheville, North Carolina, 28803, United States

Location

Sylentis Investigative Site

High Point, North Carolina, 27262, United States

Location

Sylentis Investigative Site

Fargo, North Dakota, 58103, United States

Location

Sylentis Investigative Site

Cleveland, Ohio, 44115, United States

Location

Sylentis Investigative Site

Columbus, Ohio, 43215, United States

Location

Sylentis Investigative Site

Cranberry Township, Pennsylvania, 16066, United States

Location

Sylentis Investigative Site

Rapid City, South Dakota, 57701, United States

Location

Sylentis Investigative Site

Memphis, Tennessee, 38103, United States

Location

Sylentis Investigative Site

Nashville, Tennessee, 37215, United States

Location

Sylentis Investigative Site

El Paso, Texas, 79902, United States

Location

Sylentis Investigative Site

Houston, Texas, 77030, United States

Location

Sylentis Investigative Site

Houston, Texas, 77034, United States

Location

Sylentis Investigative Site

Falls Church, Virginia, 22042, United States

Location

Sylentis Investigative Site

Pamplona, Navarre, 31008, Spain

Location

Sylentis Investigative Site

Barcelona, 08022, Spain

Location

Sylentis Investigative Site

Madrid, 28034, Spain

Location

Sylentis Investigative Site

Madrid, 28040, Spain

Location

Sylentis Investigative Site

Seville, 41009, Spain

Location

Sylentis Investigative Sites

Valladolid, 47003, Spain

Location

Sylentis Investigative Site

Zaragoza, 50004, Spain

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Sjogren's Syndrome; Keratoconjunctivitis Sicca

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 26, 2021
• Study Start: May 25, 2021
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

US (39); ES (7)