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Tolerance and Effect on Intraocular Pressure After Administration of SYL040012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00990743
Recruitment Status : Completed
First Posted : October 7, 2009
Last Update Posted : October 22, 2010
Sponsor:
Information provided by:
Sylentis, S.A.

Tracking Information
First Submitted Date  ICMJE October 5, 2009
First Posted Date  ICMJE October 7, 2009
Last Update Posted Date October 22, 2010
Study Start Date  ICMJE September 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2009)
  • Part I: Local tolerance after administration of one dose of SYL040012. [ Time Frame: Part I: 3 days ]
  • Part II: Local tolerance after 7 days administration of SYL040012 with one dose per day. [ Time Frame: Part II: 11 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2009)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tolerance and Effect on Intraocular Pressure After Administration of SYL040012
Official Title  ICMJE Phase I Study With SYL040012. Tolerance and Effect on Intraocular Pressure
Brief Summary The purpose of this study is to determine whether SYL040012 is safe for the treatment of ocular hypertension and glaucoma.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Ocular Hypertension
  • Glaucoma
Intervention  ICMJE Drug: SYL040012
Administration of single and multiple doses of SYL040012 in ophthalmic drops solution
Study Arms  ICMJE Experimental: SYL040012
Intervention: Drug: SYL040012
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 6, 2009)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00990743
Other Study ID Numbers  ICMJE 2008-008204-41
CUNFI-0511-0814
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ana Isabel Jiménez, Sylentis
Study Sponsor  ICMJE Sylentis, S.A.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Belen Sadaba, MD, PhD Clínica Universitaria de Navarra
PRS Account Sylentis, S.A.
Verification Date October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP