Tolerance and Effect on Intraocular Pressure After Administration of SYL040012

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Sylentis, S.A.

Criteria

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
• Have a BCVA (Best corrected visual acuity) of >/= 0.8 (20/25) (Snellen scale), or0.1 (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.