Tolerance and Effect on Intraocular Pressure After Administration of SYL040012

Sylentis

Status and phase

Completed

Phase 1

Conditions

Glaucoma

Ocular Hypertension

Treatments

Drug: SYL040012

Study type

Interventional

Funder types

Industry

Identifiers

NCT00990743

2008-008204-41

CUNFI-0511-0814

Details and patient eligibility

About

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

Enrollment

30 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.