['dry eye disease']
['syl1001 ophthalmic solution', 'vehicle opthalmic solution']

        Inclusion Criteria:

          -  Both genders

          -  ≥ 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 symptoms of persistent, daily, moderate to severe dry eye lasting more than six
             months.

          -  Use of artificial tears

          -  VAS scale for eye discomfort/pain between 30 - 80

          -  CFS ≥ 2 and ≤ 4 on the Oxford scale

          -  TBUT < 10 seconds

          -  Hyperemia score ≥ 1 (McMonnies scale)

          -  Schirmer's test without anesthesia ≥ 2 and < 10 mm/5min in the eye

          -  Corrected visual acuity ≥ 0.7 logMAR

        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.
      