Tolerance and Effect on Intraocular Pressure After Administration of SYL040012

Phase I Study With SYL040012. Tolerance and Effect on Intraocular Pressure

The purpose of this study is to determine whether SYL040012 is safe for the treatment of ocular hypertension and glaucoma.

Inclusion Criteria:

• Healthy volunteers, any gender
• 18 to 45 years of age,
• Subjects must provide signed informed consent prior to participation in any study-related procedures
• Body Mass Index between 19,5 and 29 kg/m2
• IOP </= 21 mmHg in both eyes
• Have a BCVA (Best corrected visual acuity) of >/= 0.8 (20/25) (Snellen scale), or </= 0.1 (LogMar units)in both eyes
• Normal Fluorescein Clearance Test in both eyes
• Normal funduscopy in both eyes

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.
• Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplastic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes
• Previous chronic processes or with rebound characteristics that could interfere with study according to the investigator's judgment.
• Volunteers who have received pharmacological treatment, including medicinal plants, during the four weeks previous to beginning the study.
• Having used anti-cholinergics, betablockers and corticoids sporadically in the last 30 days whichever the route of administration, or any med by ocular or nasal administration route.
• Case history of hypersensitivity to meds or any other allergic process
• Visual alterations: Previous eye surgery, glaucoma, uveitis or ocular surface pathology (dry eye, blepharitis).
• Volunteers with visual alteration with more than 3 dioptres in either eye
• Use of contact lenses
• Volunteer who has participated in a clinical trial during the past four months before study entry.
• Blood or derivate transfusion during the six previous months to study entry
• Case history of drug or alcohol abuse or dependence.
• Positive result in test drug abuse during selection period
• Positive serology results to hepatitis B virus (HbsAg), virus C or HIV
• Analytic alterations medically relevant, at investigator's judgement.