Tolerance and Effect on Intraocular Pressure After Administration of SYL040012

This study has been completed.
Sponsor:
Information provided by:
Sylentis, S.A.
ClinicalTrials.gov Identifier:
NCT00990743
First received: October 5, 2009
Last updated: October 21, 2010
Last verified: October 2010
  Purpose

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


Condition Intervention Phase
Ocular Hypertension
Glaucoma
Drug: SYL040012
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Phase I Study With SYL040012. Tolerance and Effect on Intraocular Pressure

Resource links provided by NLM:


Further study details as provided by Sylentis, S.A.:

Primary Outcome Measures:
  • Part I: Local tolerance after administration of one dose of SYL040012. [ Time Frame: Part I: 3 days ] [ Designated as safety issue: Yes ]
  • Part II: Local tolerance after 7 days administration of SYL040012 with one dose per day. [ Time Frame: Part II: 11 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Period I: Local Tolerance Assessment, Effect Assessment & Pharmacokinetic description after administration of one dose of SYL040012.Side effects. Analytics. [ Time Frame: Part I: 1 hour, 1, 2, 3, days ] [ Designated as safety issue: Yes ]
  • Period II:Tolerance assessment, Pharmacokinetic description, Effect assessment on the IOP after 7 days administration. Side effects. Analytics [ Time Frame: Part II: After each administration, at time 1 and 96 hours ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: September 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SYL040012 Drug: SYL040012
Administration of single and multiple doses of SYL040012 in ophthalmic drops solution

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00990743

Locations
Spain
Clinica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Sylentis, S.A.
Investigators
Principal Investigator: Belen Sadaba, MD, PhD Clínica Universitaria de Navarra
  More Information

No publications provided

Responsible Party: Ana Isabel Jiménez, Sylentis
ClinicalTrials.gov Identifier: NCT00990743     History of Changes
Other Study ID Numbers: 2008-008204-41, CUNFI-0511-0814
Study First Received: October 5, 2009
Last Updated: October 21, 2010
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Sylentis, S.A.:
Ocular hypertension
Glaucoma
Beta-blocker

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014