Tolerance and Effect on Intraocular Pressure After Administration of SYL040012

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00990743
• Other study ID #: 2008-008204-41
• Secondary ID: CUNFI-0511-0814
• Status: Completed
• Phase: Phase 1
• First received: October 5, 2009
• Last updated: October 21, 2010
• Start date: September 2009
• Est. completion date: June 2010

Study information

• Verified date: October 2010
• Source: Sylentis, S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

Drug:
• SYL040012
Administration of single and multiple doses of SYL040012 in ophthalmic drops solution

Locations

Country	Name	City	State
Spain	Clinica Universidad de Navarra	Pamplona	Navarra

Sponsors (1)

Lead Sponsor	Collaborator
Sylentis, S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Part I: Local tolerance after administration of one dose of SYL040012.		Part I: 3 days	Yes
Primary	Part II: Local tolerance after 7 days administration of SYL040012 with one dose per day.		Part II: 11 days	Yes
Secondary	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	Yes
Secondary	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	Yes