Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

Sylentis

Status and phase: Completed; Phase 3

Conditions: Sjögren Syndrome; Dry Eye Disease

Treatments: Drug: Tivanisiran sodium ophthalmic solution; Drug: Vehicle ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT04819269

SYL1001_V

Details and patient eligibility

About

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.

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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203 participants in 2 patient groups, including a placebo group

Tivanisiran sodium ophthalmic solution

Active Comparator group

Treatment:

Drug: Tivanisiran sodium ophthalmic solution

Vehicle ophthalmic solution

Placebo Comparator group

Treatment:

Drug: Vehicle ophthalmic solution