Tolerance and Effect on Intraocular Pressure After Administration of SYL040012

NCT ID: NCT00990743

Last Updated: 2010-10-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2010-06-30

Brief Summary

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

Conditions

Ocular Hypertension; Glaucoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

SYL040012

Group Type: EXPERIMENTAL

SYL040012

Intervention Type: DRUG

Administration of single and multiple doses of SYL040012 in ophthalmic drops solution

Interventions

SYL040012

Administration of single and multiple doses of SYL040012 in ophthalmic drops solution

Intervention Type: DRUG

Eligibility 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 </= 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sylentis, S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Sylentis

Principal Investigators

Belen Sadaba, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clínica Universitaria de Navarra

Locations

Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Countries

Spain

Other Identifiers

CUNFI-0511-0814

Identifier Type: -

Identifier Source: secondary_id

2008-008204-41

Identifier Type: -

Identifier Source: org_study_id