Safety Study of Tivanisiran to Treat Dry Eye (FYDES)

Sylentis

Status and phase: Completed; Phase 3

Conditions: Dry Eye Disease

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT05310422

SYL1001_VI

Details and patient eligibility

About

This study will examine the safety of tivanisiran sodium eye drops versus vehicle when dosed once daily for 1 year in subjects with signs and symptoms of dry eye disease (DED).

Enrollment: 301 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Be at least 18 years of age
• 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

Exclusion criteria

• Pregnant or breast feeding females with a postitive pregnancy test
• Women of childbearing potential not willing to use a medically acceptable contraceptive method
• Currently participating or has participated in another clinical trial within the 2 months prior to inclusion
• Current, previous chronic or recurrent medical condition that, according to the investigator, might impact on the study
• Any concomitant treatment or prior ocular procedure or surgery in either eye or alteration of the dose of systemic medications that could interfere in the trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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301 participants in 2 patient groups, including a placebo group

Tivanisiran sodium ophthalmic solution

Experimental group

Treatment:

Drug: Tivanisiran sodium ophthalmic solution

Vehicle ophthalmic solution

Placebo Comparator group

Treatment:

Drug: Vehicle ophthalmic solution