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Completed

NCT Number: NCT05310422

Safety Study of Tivanisiran to Treat Dry Eye

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).

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Key information

Conditions

Dry Eye Disease Conjunctival Diseases Conjunctivitis Corneal Diseases Dry Eye Syndromes Eye Diseases Keratitis Keratoconjunctivitis Keratoconjunctivitis Sicca Lacrimal Apparatus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sylentis Investigative Site, Chandler, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

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

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

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

  1. Frequency and percentage of subjects with ocular and non-ocular treatment emergent adverse events (TEAEs) for 1 year

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Sylentis, S.A.

Industry

Registry information

Acronym: FYDES

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Apr 5, 2022
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.

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