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

• SYL1001 (Drug): Ocular topical administration of SYL1001 for 10 consecutive days
• Placebo (Drug): Ocular topical administration of placebo for 10 consecutive days

Primary outcomes

• 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 outcomes

• 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)]

Sex: All, ages: 18 Years to any

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.

• Results publication: Benitez-Del-Castillo JM, Moreno-Montanes J, Jimenez-Alfaro I, Munoz-Negrete FJ, Turman K, Palumaa K, Sadaba B, Gonzalez MV, Ruz V, Vargas B, Paneda C, Martinez T, Bleau AM, Jimenez AI. Safety and Efficacy Clinical Trials for SYL1001, a Novel Short Interfering RNA for the Treatment of Dry Eye Disease. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6447-6454. doi: 10.1167/iovs.16-20303. PMID 27893109