Dose-finding Study to Assess the Safety and Effect of SYL1001 in Patients With Ocular Pain
1 other identifier
interventional
66
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2015
CompletedFirst Posted
Study publicly available on registry
May 28, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedApril 5, 2016
April 1, 2016
9 months
May 20, 2015
April 4, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
Change from the baseline scoring of eye pain on the Visual Analogue Scale (VAS)
10 consecutive days
Change from the baseline scoring of ocular discomfort in the Ocular Surface Disease Index (OSDI)
10 consecutive days
Change from the baseline scoring after fluorescein staining of the cornea
10 consecutive days
Frequency of occurrence of conjunctival hyperaemia
10 consecutive days
Secondary Outcomes (4)
Change from baseline in vital signs
10 consecutive days
Change from baseline in standard laboratory parameters
10 consecutive days
Assessment of Adverse Events (AEs) as a measure of SYL1001 safety
20 consecutive days
Change from baseline in standard ocular parameters
10 consecutive days
Study Arms (3)
SYL1001 eye drops dose C
EXPERIMENTALSYL1001 eye drops dose C administration via the ophthalmic route
SYL1001 eye drops dose D
EXPERIMENTALSYL1001 eye drops dose D administration via the ophthalmic route
Placebo
PLACEBO COMPARATORPlacebo eye drops administration via the ophthalmic route
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
- Another eye disease that is significant in the investigator's opinion.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sylentis, S.A.lead
Study Sites (6)
East Tallinn Central Hospital
Tallinn, 10138, Estonia
Eye Clinic Dr. Krista Turman
Tallinn, 13419, Estonia
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Fundación Jiménez Díaz
Madrid, 28040, Spain
Hospital U. Clínico San Carlos
Madrid, 28040, Spain
Clínica Universidad de Navarra
Pamplona, 31008, Spain
Related Publications (1)
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.
PMID: 27893109DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2015
First Posted
May 28, 2015
Study Start
June 1, 2015
Primary Completion
March 1, 2016
Last Updated
April 5, 2016
Record last verified: 2016-04