NCT01438281

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

July 17, 2012

Status Verified

July 1, 2012

Enrollment Period

4 months

First QC Date

September 14, 2011

Last Update Submit

July 16, 2012

Conditions

Ocular PainDry Eye

Keywords

ocular paindry eyesiRNA

Outcome Measures

Primary Outcomes (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.

    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

    Period I: 3 days, Period II: 11 days

Secondary Outcomes (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

Study Arms (1)

SYL1001

EXPERIMENTAL
Drug: SYL1001

Interventions

SYL1001DRUG

SYL1001 eye drops. topical administration

SYL1001

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (1)

  • Benitez-Del-Castillo JM, Moreno-Montanes J, Jimenez-Alfaro I, Munoz-Negrete FJ, Turman K, Palumaa K, Sadaba B, Gonzalez MV, Ruz V, Vargas B, Paneda C, Martinez T, Bleau AM, Jimenez AI. Safety and Efficacy Clinical Trials for SYL1001, a Novel Short Interfering RNA for the Treatment of Dry Eye Disease. Invest Ophthalmol Vis Sci. 2016 Nov 1;57(14):6447-6454. doi: 10.1167/iovs.16-20303.

    PMID: 27893109DERIVED

MeSH Terms

Conditions

Eye PainDry Eye Syndromes

Condition Hierarchy (Ancestors)

Eye ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsLacrimal Apparatus Diseases

Study Officials

  • Belen Sadaba, MD, PhD

    Clinica Universidad de Navarra

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2011

First Posted

September 22, 2011

Study Start

July 1, 2011

Primary Completion

November 1, 2011

Study Completion

June 1, 2012

Last Updated

July 17, 2012

Record last verified: 2012-07

Locations

ES(1)