Dry Eye Disease
Conditions
Keywords
siRNA, oligonucleotide, keratoconjunctivitis sicca, SYL1001
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).
Interventions
1 drop in the affected eye(s) once daily
DRUGVehicle ophthalmic solution
1 drop in the affected eye(s) once daily
Sponsors
Sylentis, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 positive 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number and Percentage of Subjects With Ocular and Non-ocular Treatment Emergent Adverse Events (TEAEs) for 1 Year | 1 year |
Countries
United States
Participant flow
Pre-assignment details
Participants were administerd one drop in both eyes.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 171 Participants |
| Age, Categorical Between 18 and 65 years | 130 Participants |
| Age, Continuous | 63.5 years STANDARD_DEVIATION 12.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 171 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Other American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Other Asian | 18 Participants |
| Race (NIH/OMB) Other Black or African American | 37 Participants |
| Race (NIH/OMB) Other More than one race | 1 Participants |
| Race (NIH/OMB) Other Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Other Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) Other White | 153 Participants |
| Region of Enrollment United States | 301 participants |
| Sex: Female, Male Female | 159 Participants |
| Sex: Female, Male Male | 44 Participants |
| Total Corneal Fluorescein Staining (CFS) Scale [0-15] | 6.3 units on a scale STANDARD_DEVIATION 2.2 |
| Visual Analogue Scale (VAS) Scale [0-100 mm] | 66.5 units on a scale STANDARD_DEVIATION 16.2 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 203 | 0 / 98 |
| other Total, other adverse events | 37 / 203 | 31 / 98 |
| serious Total, serious adverse events | 7 / 203 | 3 / 98 |
Outcome results
None listed