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Safety Study of Tivanisiran to Treat Dry Eye (FYDES)

Primary Purpose

Dry Eye Disease

Status
Active
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Tivanisiran sodium ophthalmic solution
Vehicle ophthalmic solution
Sponsored by
Sylentis, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease focused on measuring siRNA, oligonucleotide, keratoconjunctivitis sicca, SYL1001

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Sylentis Investigative Site
  • Sylentis Investigative Site
  • FYDES Investigative Site
  • Sylentis Investigative Site
  • Sylentis Investigative Site
  • Sylentis Investigative Site
  • Sylentis Investigative Site
  • FYDES Investigative Site
  • FYDES Investigative Site
  • Sylentis Investigative Site
  • Sylentis Investigative Site
  • Sylentis Investigative Site
  • Sylentis Investigative Site
  • FYDES Investigative Site
  • Sylentis Investigative Site
  • Sylentis Investigative Site
  • Sylentis Investigative Site
  • Sylentis Investigative Site
  • Sylentis Investigative Site
  • Sylentis Investigative Site
  • Sylentis Investigative Site
  • Sylentis Investigative Site
  • FYDES Investigative Site
  • Sylentis Investigative Site
  • Sylentis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tivanisiran sodium ophthalmic solution

Vehicle ophthalmic solution

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 25, 2022
Last Updated
October 3, 2022
Sponsor
Sylentis, S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT05310422
Brief Title
Safety Study of Tivanisiran to Treat Dry Eye
Acronym
FYDES
Official Title
Safety Study of Tivanisiran to Treat Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 24, 2022 (Actual)
Primary Completion Date
October 24, 2023 (Anticipated)
Study Completion Date
October 24, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sylentis, S.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease
Keywords
siRNA, oligonucleotide, keratoconjunctivitis sicca, SYL1001

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
301 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tivanisiran sodium ophthalmic solution
Arm Type
Experimental
Arm Title
Vehicle ophthalmic solution
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Tivanisiran sodium ophthalmic solution
Intervention Description
1 drop in the affected eye(s) once daily
Intervention Type
Drug
Intervention Name(s)
Vehicle ophthalmic solution
Intervention Description
1 drop in the affected eye(s) once daily
Primary Outcome Measure Information:
Title
Frequency and percentage of subjects with ocular and non-ocular treatment emergent adverse events (TEAEs) for 1 year
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Sylentis Investigative Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85021
Country
United States
Facility Name
Sylentis Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
FYDES Investigative Site
City
Glendale
State/Province
California
ZIP/Postal Code
91204
Country
United States
Facility Name
Sylentis Investigative Site
City
Hemet
State/Province
California
ZIP/Postal Code
92545
Country
United States
Facility Name
Sylentis Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
85032
Country
United States
Facility Name
Sylentis Investigative Site
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Sylentis Investigative Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
FYDES Investigative Site
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
FYDES Investigative Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Sylentis Investigative Site
City
Largo
State/Province
Florida
ZIP/Postal Code
33773
Country
United States
Facility Name
Sylentis Investigative Site
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
Facility Name
Sylentis Investigative Site
City
Fraser
State/Province
Michigan
ZIP/Postal Code
48026
Country
United States
Facility Name
Sylentis Investigative Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
FYDES Investigative Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Sylentis Investigative Site
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Sylentis Investigative Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Sylentis Investigative Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28803
Country
United States
Facility Name
Sylentis Investigative Site
City
Garner
State/Province
North Carolina
ZIP/Postal Code
27529
Country
United States
Facility Name
Sylentis Investigative Site
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Sylentis Investigative Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Sylentis Investigative Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Sylentis Investigative Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
FYDES Investigative Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Facility Name
Sylentis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Sylentis Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78230
Country
United States

12. IPD Sharing Statement

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Safety Study of Tivanisiran to Treat Dry Eye

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