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Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers

NCT ID: NCT01438281

Last Updated: 2012-07-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2012-06-30

Brief Summary

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

Detailed Description

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Conditions

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Ocular Pain Dry Eye

Keywords

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ocular pain dry eye siRNA

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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SYL1001

Group Type EXPERIMENTAL

SYL1001

Intervention Type DRUG

SYL1001 eye drops. topical administration

Interventions

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SYL1001

SYL1001 eye drops. topical administration

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sylentis, S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Belen Sadaba, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Clinica Universidad de Navarra

Locations

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Clinica Universidad de Navarra

Pamplona, Navarre, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 27893109 (View on PubMed)

Other Identifiers

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2010-023113-56

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SYL1001_I

Identifier Type: -

Identifier Source: org_study_id