Dose-finding Study to Assess the Safety and Effect of SYL1001 in Patients With Ocular Pain

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.

Study Overview

• Status: Completed
• Conditions: Ocular Pain; Dry Eye Syndrome
• Intervention / Treatment: Drug: SYL1001; Drug: SYL1001; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 2

Contacts and Locations

Study Locations

• Estonia
  • Tallinn, Estonia, 10138
    • East Tallinn Central Hospital
  • Tallinn, Estonia, 13419
    • Eye Clinic Dr. Krista Turman
• Spain
  • Madrid, Spain, 28040
    • Fundación Jiménez Díaz
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28040
    • Hospital U. Clínico San Carlos
  • Pamplona, Spain, 31008
    • Clinica Universidad de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SYL1001 eye drops dose C; SYL1001 eye drops dose C administration via the ophthalmic route	Drug: SYL1001; SYL1001 eye drops dose C administration for 10 consecutive days; Drug: SYL1001; SYL1001 eye drops dose D administration for 10 consecutive days
Experimental: SYL1001 eye drops dose D; SYL1001 eye drops dose D administration via the ophthalmic route	Drug: SYL1001; SYL1001 eye drops dose C administration for 10 consecutive days; Drug: SYL1001; SYL1001 eye drops dose D administration for 10 consecutive days
Placebo Comparator: Placebo; Placebo eye drops administration via the ophthalmic route	Drug: Placebo; Placebo eye drops administration for 10 consecutive days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Sylentis, S.A.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: May 20, 2015
• First Submitted That Met QC Criteria: May 25, 2015
• First Posted (Estimate): May 28, 2015

Study Record Updates

• Last Update Posted (Estimate): April 5, 2016
• Last Update Submitted That Met QC Criteria: April 4, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Pain; Neurologic Manifestations; Lacrimal Apparatus Diseases; Eye Manifestations; Dry Eye Syndromes; Eye Pain
• Other Study ID Numbers: SYL1001_III