Dose Finding Clinical Trial With SYL040012 to Evaluate the Tolerability and Effect on Intraocular Pressure in Subjects With Ocular Hypertension or Open Angle Glaucoma

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 hole study.
• •Females of childbearing potential not willing to use a medically acceptable contraceptive method from enrolment until after the follow-up visit.
• •Any current disease or condition that might compromise the respiratory, cardiovascular, endocrine, neurological, haematological, renal, or gastrointestinal function.
• •Previous chronic processes or with rebound characteristics that could interfere with the study according to the investigator's judgment.
• •Body temperature.
• •Intolerability of any components of SYL040012 or placebo.
• •Unable to comply with the clinical trial requirements as judged by the investigator.
• •Beta blockers or corticosteroids use (other than cutaneous or intra-articular) for the treatment of concurrent diseases, even if sporadically, or any ocular or nasal vasoconstrictor treatment in the last 15 days prior to the first investigational product administration
• •Previous refractive surgery; cataract extraction in the last 6 months
• •Previous surgery for glaucoma.
• •Participation in a clinical trial within 2 months before the enrolment visit
• •Use of any other investigational product within 60 days before the enrolment visit.
• •Other drugs for the treatment of concurrent diseases are allowed. However, their dosages should be kept constant throughout the study.
• •Use of contact lenses in the last 7 days prior to the first investigational product administration and wearing contact lenses throughout the trial
• •History of ocular infection or inflammation within the last 3 months before the enrolment visit
• •Angle-closure or pigmentary glaucoma.
• •Chronic or current acute eye diseases such as scleritis, uveitis, blepharitis, conjunctivitis, or ocular Herpes simplex virus infection