Clinical trial NCT00990743: Tolerance and Effect on Intraocular Pressure After Administration of SYL040012
Official title: Phase I Study With SYL040012. Tolerance and Effect on Intraocular Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ocular Hypertension
Glaucoma
Keywords: Ocular hypertension
Glaucoma
Beta-blocker
Lead sponsor: Sylentis, S.A.
Sponsor class: INDUSTRY
First posted: 2009-10-07
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Part I: Local tolerance after administration of one dose of SYL040012.
timeFrame: Part I: 3 days
measure: Part II: Local tolerance after 7 days administration of SYL040012 with one dose per day.
timeFrame: Part II: 11 days
Secondary outcomes:
measure: Period I: Local Tolerance Assessment, Effect Assessment & Pharmacokinetic description after administration of one dose of SYL040012.Side effects. Analytics.
timeFrame: Part I: 1 hour, 1, 2, 3, days
measure: Period II:Tolerance assessment, Pharmacokinetic description, Effect assessment on the IOP after 7 days administration. Side effects. Analytics
timeFrame: Part II: After each administration, at time 1 and 96 hours
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
state: Navarra
Study officials:
affiliation: Clínica Universitaria de Navarra
name: Belen Sadaba, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: