Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers

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: NCT01438281
Recruitment Status : Completed
First Posted : September 22, 2011
Last Update Posted : July 17, 2012
Information provided by (Responsible Party):
Sylentis, S.A.

Brief Summary:
The purpose of this study is to determine whether SYL1001 is safe for the prevention and treatment of ocular pain and dry eye syndrome.

Condition or disease Intervention/treatment Phase
Ocular Pain Dry Eye Drug: SYL1001 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Phase I Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers
Study Start Date : July 2011
Primary Completion Date : November 2011
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Care
U.S. FDA Resources

Arm Intervention/treatment
Experimental: SYL1001 Drug: SYL1001
SYL1001 eye drops. topical administration

Primary Outcome Measures :
  1. Local tolerance assessment of cornea and conjunctival sac after administration of one dose of SYL1001 for period 1 and after 7 days of administration of SYL1001 with one dose per day for period 2. [ Time Frame: Period I: 3 days, Period II: 11 days ]
    Local tolerance and ocular surface (cornea and conjunctival) on the area of administration 24 hours after last administration. It will be performed using a slit lamp which will be performed before, during and after the administration at established times. Adverse events will be registered and the determination of subjective tolerance will use the visual analogical scale in cases where asubjects refers them

Secondary Outcome Measures :
  1. General tolerance assessment after administration of one dose of SYL1001 (period 1) and after 7 days administration (period 2) [ Time Frame: Period I: 3 days; Period II: 11 days ]
    Corneal pachymetry eye exploration BCVA (best corrected visual acuity) eye fundus evaluation Clinical exploration Side effects

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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:

  • Subjects must provide signed inform consent prior to participation.
  • BMI between 19,5 y 29 kg/m2.
  • Normal ocular test in both eyes: IOP </=21 mmHg. BCVAof >/=0,8 (20/25)Snellen scale, or </=0.1 LogMar.
  • 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 or who will not use a medically acceptable contraceptive method from selection and during the study.
  • Current relevant disease.
  • Previous chronic processes or with rebound characteristics that could interfere with study according investigator's judgment.
  • Volunteers who have received pharmacological treatment, including medicinal plants, during the four weeks previous to beginning the study.
  • Having used corticoids sporadically in the last 30 days whichever the route aof 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, use of lenses, uveitis or ocular surface pathology (dry eye, blepharitis).
  • Volunteers with visual alteration with more than 3 dioptres in either eye.
  • Volunteers who has participated in a clinical trial during the past fout 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 o VIH.
  • 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): NCT01438281

Clinica Universidad de Navarra
Pamplona, Navarra, Spain, 31008
Sponsors and Collaborators
Sylentis, S.A.
Principal Investigator: Belen Sadaba, MD, PhD Clinica Universidad de Navarra

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Sylentis, S.A. Identifier: NCT01438281     History of Changes
Other Study ID Numbers: SYL1001_I
2010-023113-56 ( EudraCT Number )
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012

Keywords provided by Sylentis, S.A.:
ocular pain
dry eye

Additional relevant MeSH terms:
Eye Pain
Neurologic Manifestations
Nervous System Diseases
Eye Manifestations
Eye Diseases
Signs and Symptoms