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

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.