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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
History of Changes
  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:

U.S. FDA Resources

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 May 19, 2013