Back to results

Pilot Study to Evaluate SYL1001 Safety and Effect in Patients With Ocular Pain

Primary Purpose

Ocular Pain, Dry Eye Syndrome

Status

Completed

Phase

Phase 1

Locations

Spain

Study Type

Interventional

Intervention

SYL1001

Placebo

About this trial

This is an interventional treatment trial for Ocular Pain focused on measuring Ocular pain, Dry Eye Syndrome, siRNA, RNAi, TRPV1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients of both genders
Age ≥ 18 years old
Give written informed consent to participate in the study after having been informed of the study design, objectives and possible derived risks
Common mild to moderate dry eye symptoms. Persistent daily symptoms for more than three months:
OSDI scale: 13-30
VAS scale: 2-7
Ocular tests in both eyes:
Corneal staining with fluorescein. Oxford scale > 0
Tear Breakup Time Test: (BUT) < 10 seconds
Schirmer test with anaesthesia < 10 mm/5min

Exclusion Criteria:

Pregnant or breastfeeding females or those with a positive pregnancy test.
Females of childbearing potential who will not use a medically acceptable contraceptive method from selection and during the whole study.
Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplasic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes.
Past history of a chronic o recurring condition that could interfere with study according to the investigator's judgement.
Concomitant use of other drugs with analgesic activity by any route of administration at the enrolment period.
Changes in any ocular and/or systemic concomitant medication one month prior to the study commencement and during the study development.
Changes on the preestablished artificial tears dosage 15 days prior to the study commencement and during the study development.
Cyclosporine treatment initiation or changes in cyclosporine dosage or dosing regimen during the 6 months prior to enrolment.
Previous history of drug hypersensitivity.
Use of contact lenses
Case history of drug or alcohol abuse or dependence.
Relevant abnormal laboratory results as judged by the investigator
Previous refractive surgery
Participation in a clinical trial within 2 months before the enrolment visit
Relevant ocular pathology judged by the investigator.

Sites / Locations

Fundación Jiménez Díaz
Hospital Universitario Clínico San Carlos
Instituto Oftalmológico Fernández-Vega

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SYL1001 eye drops dose A

Placebo

Arm Description

Ocular topical administration of SYL1001 eye drops dose A

Ocular topical administration of placebo eye drops

Outcomes

Primary Outcome Measures

Changes from Baseline in the Ocular Pain Scores on the Visual Analog Scale (VAS) and in the Ocular Discomfort Scores on the Ocular Surface Disease Index (OSDI) as a Measure of SYL1001 Analgesic Effect versus Placebo.

Simple Corneal and Conjunctival Evaluation as a Measure of Safety and Tolerability using Ophthalmic Dyes and a Slit Lamp

Secondary Outcome Measures

Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability

Evaluation of Vital Signs, Blood, Urine and Ocular Parameters Alterations (IOP, Visual Acuity, Anterior Segment Exploration) Possibly Related to the Investigational Product

Full Information

NCT ID

NCT01776658

First Posted

November 14, 2012

Last Updated

May 22, 2015

Sponsor

Sylentis, S.A.

1. Study Identification

Unique Protocol Identification Number

NCT01776658

Brief Title

Pilot Study to Evaluate SYL1001 Safety and Effect in Patients With Ocular Pain

Study Type

Interventional

2. Study Status

Record Verification Date

May 2015

Overall Recruitment Status

Completed

Study Start Date

November 2012 (undefined)

Primary Completion Date

April 2015 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sylentis, S.A.

4. Oversight

5. Study Description

Brief Summary

The aim of this pilot study is to compare the analgesic effect of SYL1001 versus placebo in patients with ocular pain associated with Dry Eye Syndrome. General and local tolerability are also evaluated.

6. Conditions and Keywords

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

Ocular Pain, Dry Eye Syndrome

Keywords

Ocular pain, Dry Eye Syndrome, siRNA, RNAi, TRPV1

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SYL1001 eye drops dose A

Arm Type

Experimental

Arm Description

Ocular topical administration of SYL1001 eye drops dose A

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Ocular topical administration of placebo eye drops

Intervention Type

Drug

Intervention Name(s)

SYL1001

Intervention Description

Ocular topical administration of SYL1001 for 10 consecutive days

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Ocular topical administration of placebo for 10 consecutive days

Primary Outcome Measure Information:

Title

Time Frame

10 days + (4-10 days)

Title

Simple Corneal and Conjunctival Evaluation as a Measure of Safety and Tolerability using Ophthalmic Dyes and a Slit Lamp

Time Frame

10 days + (4-10 days)

Secondary Outcome Measure Information:

Title

Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability

Time Frame

10 days + (96-240 hours)

Title

Evaluation of Vital Signs, Blood, Urine and Ocular Parameters Alterations (IOP, Visual Acuity, Anterior Segment Exploration) Possibly Related to the Investigational Product

Time Frame

10 days + (96-240 hours)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients of both genders Age ≥ 18 years old Give written informed consent to participate in the study after having been informed of the study design, objectives and possible derived risks Common mild to moderate dry eye symptoms. Persistent daily symptoms for more than three months: OSDI scale: 13-30 VAS scale: 2-7 Ocular tests in both eyes: Corneal staining with fluorescein. Oxford scale > 0 Tear Breakup Time Test: (BUT) < 10 seconds Schirmer test with anaesthesia < 10 mm/5min Exclusion Criteria: Pregnant or breastfeeding females or those with a positive pregnancy test. Females of childbearing potential who will not use a medically acceptable contraceptive method from selection and during the whole study. Current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplasic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes. Past history of a chronic o recurring condition that could interfere with study according to the investigator's judgement. Concomitant use of other drugs with analgesic activity by any route of administration at the enrolment period. Changes in any ocular and/or systemic concomitant medication one month prior to the study commencement and during the study development. Changes on the preestablished artificial tears dosage 15 days prior to the study commencement and during the study development. Cyclosporine treatment initiation or changes in cyclosporine dosage or dosing regimen during the 6 months prior to enrolment. Previous history of drug hypersensitivity. Use of contact lenses Case history of drug or alcohol abuse or dependence. Relevant abnormal laboratory results as judged by the investigator Previous refractive surgery Participation in a clinical trial within 2 months before the enrolment visit Relevant ocular pathology judged by the investigator.

Facility Information:

Facility Name

Fundación Jiménez Díaz

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Hospital Universitario Clínico San Carlos

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Instituto Oftalmológico Fernández-Vega

City

Oviedo

ZIP/Postal Code

33012

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

Learn more about this trial

Pilot Study to Evaluate SYL1001 Safety and Effect in Patients With Ocular Pain

We'll reach out to this number within 24 hrs