Pilot Study to Evaluate SYL1001 Safety and Effect in Patients With Ocular Pain

Study Overview
=================
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.

Conditions
-----------------
Ocular Pain, Dry Eye Syndrome

Intervention / Treatment
-----------------
* Drug: SYL1001
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYL1001 eye drops dose A<br>Ocular topical administration of SYL1001 eye drops dose A | Drug: SYL1001<br>* Ocular topical administration of SYL1001 for 10 consecutive days<br>|
| Placebo Comparator: Placebo<br>Ocular topical administration of placebo eye drops | Drug: Placebo<br>* Ocular topical administration of placebo for 10 consecutive days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ocular pain, Dry Eye Syndrome, siRNA, RNAi, TRPV1