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Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers

Sponsor
Sylentis, S.A. (Industry)
Overall Status
Completed
CT.gov ID
NCT01438281
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
11
Duration (Months)
2.7
Patients Per Site Per Month

Study Details

Study Description

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
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
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 :
Jul 1, 2011
Actual Primary Completion Date :
Nov 1, 2011
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: SYL1001

Drug: SYL1001
SYL1001 eye drops. topical administration

Outcome Measures

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. [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) [Period I: 3 days; Period II: 11 days]

    Corneal pachymetry eye exploration BCVA (best corrected visual acuity) eye fundus evaluation Clinical exploration Side effects

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sylentis, S.A.
ClinicalTrials.gov Identifier:
NCT01438281
Other Study ID Numbers:
  • SYL1001_I
  • 2010-023113-56
First Posted:
Sep 22, 2011
Last Update Posted:
Jul 17, 2012
Last Verified:
Jul 1, 2012
Keywords provided by Sylentis, S.A.
ocular pain
dry eye
siRNA
Additional relevant MeSH terms:
Dry Eye Syndromes
Eye Pain

Study Results

No Results Posted as of Jul 17, 2012