Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sylentis, S.A.
ClinicalTrials.gov Identifier:
NCT01438281
First received: September 14, 2011
Last updated: July 16, 2012
Last verified: July 2012
  Purpose

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 Intervention Phase
Ocular Pain
Dry Eye
Drug: SYL1001
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 to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers

Resource links provided by NLM:


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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: Yes ]
    Corneal pachymetry eye exploration BCVA (best corrected visual acuity) eye fundus evaluation Clinical exploration Side effects


Enrollment: 30
Study Start Date: July 2011
Study Completion Date: June 2012
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SYL1001 Drug: SYL1001
SYL1001 eye drops. topical administration

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438281

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

No publications provided

Responsible Party: Sylentis, S.A.
ClinicalTrials.gov Identifier: NCT01438281     History of Changes
Other Study ID Numbers: SYL1001_I, 2010-023113-56
Study First Received: September 14, 2011
Last Updated: July 16, 2012
Health Authority: Spain: Spanish Agency of Medicines

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

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Pain
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Eye Manifestations
Signs and Symptoms
Pain

ClinicalTrials.gov processed this record on July 23, 2014