Tolerance and Effect on Intraocular Pressure After Administration of SYL040012

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

Official Title
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Phase I Study With SYL040012. Tolerance and Effect on Intraocular Pressure

Conditions
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Ocular Hypertension, Glaucoma

Intervention / Treatment
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* Drug: SYL040012


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYL040012<br> | Drug: SYL040012<br>* Administration of single and multiple doses of SYL040012 in ophthalmic drops solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ocular hypertension, Glaucoma, Beta-blocker