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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. Identifier: NCT00990743
Recruitment Status : Completed
First Posted : October 7, 2009
Last Update Posted : October 22, 2010
Information provided by:
Sylentis, S.A.

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

Condition or disease Intervention/treatment Phase
Ocular Hypertension Glaucoma Drug: SYL040012 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Phase I Study With SYL040012. Tolerance and Effect on Intraocular Pressure
Study Start Date : September 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: SYL040012 Drug: SYL040012
Administration of single and multiple doses of SYL040012 in ophthalmic drops solution

Primary Outcome Measures :
  1. Part I: Local tolerance after administration of one dose of SYL040012. [ Time Frame: Part I: 3 days ]
  2. Part II: Local tolerance after 7 days administration of SYL040012 with one dose per day. [ Time Frame: Part II: 11 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00990743

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Clinica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Sylentis, S.A.
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Principal Investigator: Belen Sadaba, MD, PhD Clínica Universitaria de Navarra
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Responsible Party: Ana Isabel Jiménez, Sylentis Identifier: NCT00990743    
Other Study ID Numbers: 2008-008204-41
First Posted: October 7, 2009    Key Record Dates
Last Update Posted: October 22, 2010
Last Verified: October 2010
Keywords provided by Sylentis, S.A.:
Ocular hypertension
Additional relevant MeSH terms:
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Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases