Tolerance and Effect on Intraocular Pressure After Administration of SYL040012

Phase 1

Completed

• Conditions: Ocular Hypertension; Glaucoma
• Interventions: Drug: SYL040012

• Registration Number: NCT00990743
• Lead Sponsor: Sylentis, S.A.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-10-05
• Study First Submitted QC: 2009-10-06
• Study First Posted: 2009-10-07
• Primary Completion: 2010-06
• Study Completion: 2010-06
• Status Verified: 2010-10
• Last Update Submitted: 2010-10-21
• Last Update Posted: 2010-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SYL040012	SYL040012	-

Primary Outcome Measures

Name	Time	Method
Part I: Local tolerance after administration of one dose of SYL040012.	Part I: 3 days
Part II: Local tolerance after 7 days administration of SYL040012 with one dose per day.	Part II: 11 days

Secondary Outcome Measures

Name	Time	Method
Period I: Local Tolerance Assessment, Effect Assessment & Pharmacokinetic description after administration of one dose of SYL040012.Side effects. Analytics.	Part I: 1 hour, 1, 2, 3, days
Period II:Tolerance assessment, Pharmacokinetic description, Effect assessment on the IOP after 7 days administration. Side effects. Analytics	Part II: After each administration, at time 1 and 96 hours

Trial Locations

Locations (1)

Clinica Universidad de Navarra; 🇪🇸 Pamplona, Navarra, Spain