Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

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.

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Key information

Conditions

Dry Eye Disease Arthritis Arthritis, Rheumatoid Autoimmune Diseases Conjunctival Diseases Conjunctivitis Connective Tissue Diseases Corneal Diseases Dry Eye Syndromes Eye Diseases Immune System Diseases Joint Diseases Keratitis Keratoconjunctivitis Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren's Syndrome Sjögren Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sylentis Investigative Site, Pamplona, Navarre, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tivanisiran sodium ophthalmic solution

Drug

1 drop in the affected eye(s) once daily

Vehicle Ophthalmic Solution

Drug

1 drop in the affected eye(s) once daily

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Sylentis, S.A.

Industry

Registry information

Important dates

Study start: 2021
Primary completion: 2023
Study completion: 2023
First posted: Mar 26, 2021
Registry last updated: Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed