Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

Sponsor

Sylentis, S.A. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04819269

Collaborator

(none)

200

Enrollment

Locations

Arms

20.9

Anticipated Duration (Months)

5.4

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease Sjögren Syndrome	Drug: Tivanisiran sodium ophthalmic solution Drug: Vehicle ophthalmic solution	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Tivanisiran for Dry Eye in Subjects With Sjögren's Syndrome

Actual Study Start Date :

May 25, 2021

Anticipated Primary Completion Date :

Dec 20, 2022

Anticipated Study Completion Date :

Feb 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tivanisiran sodium ophthalmic solution	Drug: Tivanisiran sodium ophthalmic solution 1 drop in the affected eye(s) once daily
Placebo Comparator: Vehicle ophthalmic solution	Drug: Vehicle ophthalmic solution 1 drop in the affected eye(s) once daily

Arm

Intervention/Treatment

Active Comparator: Tivanisiran sodium ophthalmic solution

Drug: Tivanisiran sodium ophthalmic solution

1 drop in the affected eye(s) once daily

Placebo Comparator: Vehicle ophthalmic solution

Drug: Vehicle ophthalmic solution

1 drop in the affected eye(s) once daily

Outcome Measures

Primary Outcome Measures

Change from baseline in Corneal Fluorescein Staining (CFS) scale [0-3]. Higher scores mean disease worsening. [85 days]
Change from baseline in Dry Eye Symptom scale [0-100]. Higher scores mean disease worsening. [85 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sylentis Investigative Site	Dothan	Alabama	United States	36301
2	Sylentis Investigative Site	Scottsdale	Arizona	United States	85254
3	Sylentis Investigative Site	Glendale	California	United States	91204
4	Sylentis Investigative Site	Los Angeles	California	United States	90013
5	Sylentis Investigative Site	Newport Beach	California	United States	92663
6	Sylentis Investigative Site	Rancho Cordova	California	United States	95670
7	Sylentis Investigative Site	San Diego	California	United States	92122
8	Sylentis Investigative Site	Torrance	California	United States	90505
9	Sylentis Investigative Site	Aurora	Colorado	United States	80045
10	Sylentis Investigative Site	Colorado Springs	Colorado	United States	80907
11	Sylentis Investigative Site	Littleton	Colorado	United States	80120
12	Sylentis Investigative Site	Jacksonville	Florida	United States	32256
13	Sylentis Investigative Site	Largo	Florida	United States	33773
14	Sylentis Investigative Site	Miami	Florida	United States	33136
15	Sylentis Investigative Site	Ormond Beach	Florida	United States	32174
16	Sylentis Investigative Site	Tampa	Florida	United States	33603
17	Sylentis Investigative Site	Atlanta	Georgia	United States	30339
18	Sylentis Investigative Site	Morrow	Georgia	United States	30260
19	Sylentis Investigative Site	Carmel	Indiana	United States	46290
20	Sylentis Investigative Site	Waltham	Massachusetts	United States	02451
21	Sylentis Investigative Site	Ypsilanti	Michigan	United States	48197
22	Sylentis Investigative Site	Kansas City	Missouri	United States	64111
23	Sylentis Investigative Site	Saint Louis	Missouri	United States	63131
24	Sylentis Investigative Site	Washington	Missouri	United States	63090
25	Sylentis Investigative Site	Asheville	North Carolina	United States	28803
26	Sylentis Investigative Site	High Point	North Carolina	United States	27262
27	Sylentis Investigative Site	Fargo	North Dakota	United States	58103
28	Sylentis Investigative Site	Cleveland	Ohio	United States	44115
29	Sylentis Investigative Site	Columbus	Ohio	United States	43215
30	Sylentis Investigative Site	Cranberry Township	Pennsylvania	United States	16066
31	Sylentis Investigative Site	Rapid City	South Dakota	United States	57701
32	Sylentis Investigative Site	Memphis	Tennessee	United States	38103
33	Sylentis Investigative Site	Nashville	Tennessee	United States	37215
34	Sylentis Investigative Site	El Paso	Texas	United States	79902
35	Sylentis Investigative Site	Houston	Texas	United States	77030
36	Sylentis Investigative Site	Houston	Texas	United States	77034
37	Sylentis Investigative Site	Falls Church	Virginia	United States	22042