Dose-finding Study to Assess the Safety and Effect of SYL1001 in Patients With Ocular Pain

• SYL1001 (Drug): SYL1001 eye drops dose C administration for 10 consecutive days
• SYL1001 (Drug): SYL1001 eye drops dose D administration for 10 consecutive days
• Placebo (Drug): Placebo eye drops administration for 10 consecutive days

Primary outcomes

• Change from the baseline scoring of eye pain on the Visual Analogue Scale (VAS) [10 consecutive days]
• Change from the baseline scoring of ocular discomfort in the Ocular Surface Disease Index (OSDI) [10 consecutive days]
• Change from the baseline scoring after fluorescein staining of the cornea [10 consecutive days]
• Frequency of occurrence of conjunctival hyperaemia [10 consecutive days]

Secondary outcomes

• Change from baseline in vital signs [10 consecutive days]
• Change from baseline in standard laboratory parameters [10 consecutive days]
• Assessment of Adverse Events (AEs) as a measure of SYL1001 safety [20 consecutive days]
• Change from baseline in standard ocular parameters [10 consecutive days]

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Give written informed consent to participate in the study, after having received all information relating to the design, aims and possible risks resulting therefrom.
* Common symptoms of persistent, daily, mild to moderate dry eye lasting more than three months: OSDI scale between 13-70 and VAS scale between 2 -7.
* Eye tests in both eyes: Corneal fluorescein staining (Oxford scale > 0), Tear break-up time < 10 seconds and Schirmer's test with anaesthesia < 10 mm/5min.

Exclusion criteria:

* Women who are pregnant or breastfeeding or who have a positive urine pregnancy test. Women who do not commit to use a medically acceptable method of contraception from the time of selection and throughout the study.
* Any current, relevant disease, including respiratory disease, cardiovascular disease, endocrine disease, neurological disease, haematological disease, kidney disease, oncological disease, liver disease, gastrointestinal dysfunction, hypertension or active acute infectious processes.
* Previous chronic or recurrent processes which, according to the investigator, could affect the development of the study.
* Concomitant use of other medications with analgesic activity by any route of administration at the time of entry into the study.
* Change in any concomitant eye and/or systemic medication of the patient one month before the study and during the study.
* Changes in the pre-established administration schedule of artificial tears during the 15 days before the study and during the 10 days of the study.
* Initiation of treatment with cyclosporine or changes in the dosage or administration schedule of cyclosporine within the 6 months before inclusion in the study.
* History of hypersensitivity to drugs.
* Use of contact lenses during the treatment and previous 15 days.
* History of drug abuse or drug or alcohol dependence.
* Laboratory abnormalities which, in the investigator's opinion, are clinically significant.
* Previous refractive surgery.
* Having participated in another clinical trial within the 2 months prior to inclusion.
* Another eye disease that is significant in the investigator's opinion.

• 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