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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
Sponsored by
Sylentis, S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

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

First Posted
November 14, 2012
Last Updated
May 22, 2015
Sponsor
Sylentis, S.A.
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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
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.
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
No
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
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Pilot Study to Evaluate SYL1001 Safety and Effect in Patients With Ocular Pain

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