Overview

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), 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.