Status:
COMPLETED
Tolerance and Effect on Intraocular Pressure After Administration of SYL040012
Lead Sponsor:
Sylentis, S.A.
Conditions:
Ocular Hypertension
Glaucoma
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to determine whether SYL040012 is safe for the treatment of ocular hypertension and glaucoma.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00990743
Start Date
September 1 2009
End Date
June 1 2010
Last Update
October 22 2010
Active Locations (1)
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1
Clinica Universidad de Navarra
Pamplona, Navarre, Spain, 31008