Back to resultsDose-finding Study to Assess the Safety and Effect of SYL1001 in Patients With Ocular Pain
Primary Purpose
Ocular Pain, Dry Eye Syndrome
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SYL1001
SYL1001
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Ocular Pain
Eligibility Criteria
Inclusion Criteria:
- Give written informed consent to participate in the study, after having received all information relating to the design, aims and possible risks resulting therefrom.
- Common symptoms of persistent, daily, mild to moderate dry eye lasting more than three months: OSDI scale between 13-70 and VAS scale between 2 -7.
- Eye tests in both eyes: Corneal fluorescein staining (Oxford scale > 0), Tear break-up time < 10 seconds and Schirmer's test with anaesthesia < 10 mm/5min.
Exclusion criteria:
- Women who are pregnant or breastfeeding or who have a positive urine pregnancy test. Women who do not commit to use a medically acceptable method of contraception from the time of selection and throughout the study.
- Any current, relevant disease, including respiratory disease, cardiovascular disease, endocrine disease, neurological disease, haematological disease, kidney disease, oncological disease, liver disease, gastrointestinal dysfunction, hypertension or active acute infectious processes.
- Previous chronic or recurrent processes which, according to the investigator, could affect the development of the study.
- Concomitant use of other medications with analgesic activity by any route of administration at the time of entry into the study.
- Change in any concomitant eye and/or systemic medication of the patient one month before the study and during the study.
- Changes in the pre-established administration schedule of artificial tears during the 15 days before the study and during the 10 days of the study.
- Initiation of treatment with cyclosporine or changes in the dosage or administration schedule of cyclosporine within the 6 months before inclusion in the study.
- History of hypersensitivity to drugs.
- Use of contact lenses during the treatment and previous 15 days.
- History of drug abuse or drug or alcohol dependence.
- Laboratory abnormalities which, in the investigator's opinion, are clinically significant.
- Previous refractive surgery.
- Having participated in another clinical trial within the 2 months prior to inclusion.
- Another eye disease that is significant in the investigator's opinion.
Sites / Locations
- East Tallinn Central Hospital
- Eye Clinic Dr. Krista Turman
- Hospital Universitario Ramón y Cajal
- Fundación Jiménez Díaz
- Hospital U. Clínico San Carlos
- Clínica Universidad de Navarra
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
SYL1001 eye drops dose C
SYL1001 eye drops dose D
Placebo
Arm Description
SYL1001 eye drops dose C administration via the ophthalmic route
SYL1001 eye drops dose D administration via the ophthalmic route
Placebo eye drops administration via the ophthalmic route
Outcomes
Primary Outcome Measures
Change from the baseline scoring of eye pain on the Visual Analogue Scale (VAS)
Change from the baseline scoring of ocular discomfort in the Ocular Surface Disease Index (OSDI)
Change from the baseline scoring after fluorescein staining of the cornea
Frequency of occurrence of conjunctival hyperaemia
Secondary Outcome Measures
Change from baseline in vital signs
Change from baseline in standard laboratory parameters
Assessment of Adverse Events (AEs) as a measure of SYL1001 safety
Change from baseline in standard ocular parameters
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02455999
Brief Title
Dose-finding Study to Assess the Safety and Effect of SYL1001 in Patients With Ocular Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
March 2016 (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 two strengths of SYL1001 eye drops 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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SYL1001 eye drops dose C
Arm Type
Experimental
Arm Description
SYL1001 eye drops dose C administration via the ophthalmic route
Arm Title
SYL1001 eye drops dose D
Arm Type
Experimental
Arm Description
SYL1001 eye drops dose D administration via the ophthalmic route
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo eye drops administration via the ophthalmic route
Intervention Type
Drug
Intervention Name(s)
SYL1001
Intervention Description
SYL1001 eye drops dose C administration for 10 consecutive days
Intervention Type
Drug
Intervention Name(s)
SYL1001
Intervention Description
SYL1001 eye drops dose D administration for 10 consecutive days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo eye drops administration for 10 consecutive days
Primary Outcome Measure Information:
Title
Change from the baseline scoring of eye pain on the Visual Analogue Scale (VAS)
Time Frame
10 consecutive days
Title
Change from the baseline scoring of ocular discomfort in the Ocular Surface Disease Index (OSDI)
Time Frame
10 consecutive days
Title
Change from the baseline scoring after fluorescein staining of the cornea
Time Frame
10 consecutive days
Title
Frequency of occurrence of conjunctival hyperaemia
Time Frame
10 consecutive days
Secondary Outcome Measure Information:
Title
Change from baseline in vital signs
Time Frame
10 consecutive days
Title
Change from baseline in standard laboratory parameters
Time Frame
10 consecutive days
Title
Assessment of Adverse Events (AEs) as a measure of SYL1001 safety
Time Frame
20 consecutive days
Title
Change from baseline in standard ocular parameters
Time Frame
10 consecutive days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Give written informed consent to participate in the study, after having received all information relating to the design, aims and possible risks resulting therefrom.
Common symptoms of persistent, daily, mild to moderate dry eye lasting more than three months: OSDI scale between 13-70 and VAS scale between 2 -7.
Eye tests in both eyes: Corneal fluorescein staining (Oxford scale > 0), Tear break-up time < 10 seconds and Schirmer's test with anaesthesia < 10 mm/5min.
Exclusion criteria:
Women who are pregnant or breastfeeding or who have a positive urine pregnancy test. Women who do not commit to use a medically acceptable method of contraception from the time of selection and throughout the study.
Any current, relevant disease, including respiratory disease, cardiovascular disease, endocrine disease, neurological disease, haematological disease, kidney disease, oncological disease, liver disease, gastrointestinal dysfunction, hypertension or active acute infectious processes.
Previous chronic or recurrent processes which, according to the investigator, could affect the development of the study.
Concomitant use of other medications with analgesic activity by any route of administration at the time of entry into the study.
Change in any concomitant eye and/or systemic medication of the patient one month before the study and during the study.
Changes in the pre-established administration schedule of artificial tears during the 15 days before the study and during the 10 days of the study.
Initiation of treatment with cyclosporine or changes in the dosage or administration schedule of cyclosporine within the 6 months before inclusion in the study.
History of hypersensitivity to drugs.
Use of contact lenses during the treatment and previous 15 days.
History of drug abuse or drug or alcohol dependence.
Laboratory abnormalities which, in the investigator's opinion, are clinically significant.
Previous refractive surgery.
Having participated in another clinical trial within the 2 months prior to inclusion.
Another eye disease that is significant in the investigator's opinion.
Facility Information:
Facility Name
East Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
Eye Clinic Dr. Krista Turman
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Fundación Jiménez Díaz
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital U. Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Clínica Universidad de Navarra
City
Pamplona
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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Dose-finding Study to Assess the Safety and Effect of SYL1001 in Patients With Ocular Pain
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