Clinical trial NCT02455999: Dose-finding Study to Assess the Safety and Effect of SYL1001 in Patients With Ocular Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Pain
Dry Eye Syndrome
Lead sponsor: Sylentis, S.A.
Sponsor class: INDUSTRY
First posted: 2015-05-28
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change from the baseline scoring of eye pain on the Visual Analogue Scale (VAS)
timeFrame: 10 consecutive days
measure: Change from the baseline scoring of ocular discomfort in the Ocular Surface Disease Index (OSDI)
timeFrame: 10 consecutive days
measure: Change from the baseline scoring after fluorescein staining of the cornea
timeFrame: 10 consecutive days
measure: Frequency of occurrence of conjunctival hyperaemia
timeFrame: 10 consecutive days
Secondary outcomes:
measure: Change from baseline in vital signs
timeFrame: 10 consecutive days
measure: Change from baseline in standard laboratory parameters
timeFrame: 10 consecutive days
measure: Assessment of Adverse Events (AEs) as a measure of SYL1001 safety
timeFrame: 20 consecutive days
measure: Change from baseline in standard ocular parameters
timeFrame: 10 consecutive days
Other outcomes:
Locations:
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: Eye Clinic Dr. Krista Turman
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Madrid
country: Spain
facility: Fundación Jiménez Díaz
city: Madrid
country: Spain
facility: Hospital U. Clínico San Carlos
city: Pamplona
country: Spain
facility: Clínica Universidad de Navarra
Study officials:
References:
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.