Dry Eye Disease
Conditions
Keywords
SYL1001, siRNA
Brief summary
The purpose of this study is to determine whether SYL1001 ophthalmic solution is safe and effective in the treatment of signs and symptoms of Dry Eye Disease.
Interventions
DRUGSYL1001 ophthalmic solution
1 drop in the affected eye
1 drop in the affected eye
Sponsors
Sylentis, S.A.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Both genders * ≥ 18 years old * Give written informed consent to participate in the study after having been informed of the study design, objectives and possible derived risks * Common symptoms of persistent, daily, moderate to severe dry eye lasting more than six months. * Use of artificial tears * VAS scale for eye discomfort/pain between 30 - 80 * CFS ≥ 2 and ≤ 4 on the Oxford scale * TBUT \< 10 seconds * Hyperemia score ≥ 1 (McMonnies scale) * Schirmer's test without anesthesia ≥ 2 and \< 10 mm/5min in the eye * Corrected visual acuity ≥ 0.7 logMAR
Exclusion criteria
* Pregnant or breastfeeding females or those with a positive pregnancy test. * Females of childbearing potential who will not use a medically acceptable contraceptive method from selection and during the whole study. * Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplasic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes. * Past history of a chronic o recurring condition that could interfere with study according to the investigator's judgement. * Concomitant use of other drugs with analgesic activity by any route of administration at the enrolment period. * Changes in any ocular and/or systemic concomitant medication one month prior to the study commencement and during the study development. * Changes on the preestablished artificial tears dosage 15 days prior to the study commencement and during the study development. * Cyclosporine treatment initiation or changes in cyclosporine dosage or dosing regimen during the 6 months prior to enrolment. * Previous history of drug hypersensitivity. * Use of contact lenses * Case history of drug or alcohol abuse or dependence. * Relevant abnormal laboratory results as judged by the investigator * Previous refractive surgery * Participation in a clinical trial within 2 months before the enrolment visit * Relevant ocular pathology judged by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in Visual Analogue Scale (VAS) scores for eye discomfort/pain as a measurement of SYL1001 effect versus vehicle | 28 days |
| Change from baseline in Corneal Fluorescein Staining (CFS) total scores obtained on the Oxford scale as a measurement of SYL1001 effect versus vehicle | 28 days |
| Change from baseline in conjunctival hyperaemia scores based on the McMonnies scale as a measurement of SYL1001 effect versus vehicle | 28 days |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability | 28 days |
Countries
Estonia, Germany, Italy, Portugal, Slovakia, Spain
Outcome results
None listed