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

September 14, 2011
July 16, 2012
July 2011
November 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01438281 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers
Phase I Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers

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

Not Provided
Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Ocular Pain
  • Dry Eye
Drug: SYL1001
SYL1001 eye drops. topical administration
Experimental: SYL1001
Intervention: Drug: SYL1001
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2012
November 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01438281
SYL1001_I, 2010-023113-56
No
Sylentis, S.A.
Sylentis, S.A.
Not Provided
Principal Investigator: Belen Sadaba, MD, PhD Clinica Universidad de Navarra
Sylentis, S.A.
July 2012

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