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

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.