Dry Eye Syndrome, Ocular Pain
Conditions
Keywords
Ocular pain, Dry Eye Syndrome, siRNA, RNAi, TRPV1
Brief summary
The aim of this pilot study is to compare the analgesic effect of SYL1001 versus placebo in patients with ocular pain associated with Dry Eye Syndrome. General and local tolerability are also evaluated.
Interventions
DRUGSYL1001
Ocular topical administration of SYL1001 for 10 consecutive days
DRUGPlacebo
Ocular topical administration of placebo for 10 consecutive days
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
* Patients of both genders * Age ≥ 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 mild to moderate dry eye symptoms. Persistent daily symptoms for more than three months: * OSDI scale: 13-30 * VAS scale: 2-7 * Ocular tests in both eyes: * Corneal staining with fluorescein. Oxford scale \> 0 * Tear Breakup Time Test: (BUT) \< 10 seconds * Schirmer test with anaesthesia \< 10 mm/5min
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 |
|---|---|
| Changes from Baseline in the Ocular Pain Scores on the Visual Analog Scale (VAS) and in the Ocular Discomfort Scores on the Ocular Surface Disease Index (OSDI) as a Measure of SYL1001 Analgesic Effect versus Placebo. | 10 days + (4-10 days) |
| Simple Corneal and Conjunctival Evaluation as a Measure of Safety and Tolerability using Ophthalmic Dyes and a Slit Lamp | 10 days + (4-10 days) |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability | 10 days + (96-240 hours) |
| Evaluation of Vital Signs, Blood, Urine and Ocular Parameters Alterations (IOP, Visual Acuity, Anterior Segment Exploration) Possibly Related to the Investigational Product | 10 days + (96-240 hours) |
Countries
Spain
Outcome results
None listed