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Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers

Primary Purpose

Ocular Pain, Dry Eye

Status

Completed

Phase

Phase 1

Locations

Spain

Study Type

Interventional

Intervention

SYL1001

About this trial

This is an interventional treatment trial for Ocular Pain focused on measuring ocular pain, dry eye, siRNA

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Clinica Universidad de Navarra

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SYL1001

Arm Description

Outcomes

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.

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)

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

Full Information

NCT ID

NCT01438281

First Posted

September 14, 2011

Last Updated

July 16, 2012

Sponsor

Sylentis, S.A.

1. Study Identification

Unique Protocol Identification Number

NCT01438281

Brief Title

Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers

Official Title

Phase I Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

July 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sylentis, S.A.

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ocular Pain, Dry Eye

Keywords

ocular pain, dry eye, siRNA

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

N/A

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SYL1001

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

SYL1001

Intervention Description

SYL1001 eye drops. topical administration

Primary Outcome Measure Information:

Title

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.

Description

Time Frame

Period I: 3 days, Period II: 11 days

Secondary Outcome Measure Information:

Title

General tolerance assessment after administration of one dose of SYL1001 (period 1) and after 7 days administration (period 2)

Description

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

Time Frame

Period I: 3 days; Period II: 11 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Belen Sadaba, MD, PhD

Organizational Affiliation

Clinica Universidad de Navarra

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clinica Universidad de Navarra

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

27893109

Citation

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.

Results Reference

derived

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Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers

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