Pilot Study to Evaluate SYL1001 Safety and Effect in Patients With Ocular Pain

NCT01776658 | Completed Phase 1

• 1 other identifier: SYL1001_II
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Ocular Pain; Dry Eye Syndrome

Keywords

Ocular pain; Dry Eye Syndrome; siRNA; RNAi; TRPV1

Outcome Measures

Primary Outcomes (2)

• 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.

  10 days + (4-10 days)

• Simple Corneal and Conjunctival Evaluation as a Measure of Safety and Tolerability using Ophthalmic Dyes and a Slit Lamp

  10 days + (4-10 days)

Secondary Outcomes (2)

• Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability

  10 days + (96-240 hours)

• Evaluation of Vital Signs, Blood, Urine and Ocular Parameters Alterations (IOP, Visual Acuity, Anterior Segment Exploration) Possibly Related to the Investigational Product

  10 days + (96-240 hours)

Study Arms (2)

SYL1001 eye drops dose A

EXPERIMENTAL

Ocular topical administration of SYL1001 eye drops dose A

Drug: SYL1001

Placebo

PLACEBO COMPARATOR

Ocular topical administration of placebo eye drops

Drug: Placebo

Interventions

SYL1001 DRUG

Ocular topical administration of SYL1001 for 10 consecutive days

SYL1001 eye drops dose A

Placebo DRUG

Ocular topical administration of placebo for 10 consecutive days

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sylentis, S.A.: lead

Study Sites (3)

Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Hospital Universitario Clínico San Carlos

Madrid, 28040, Spain

Location

Instituto Oftalmológico Fernández-Vega

Oviedo, 33012, Spain

Location

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: 27893109 DERIVED

MeSH Terms

Conditions

Eye Pain; Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Eye Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Lacrimal Apparatus Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: November 14, 2012
• First Posted: January 28, 2013
• Study Start: November 1, 2012
• Primary Completion: April 1, 2015
• Last Updated: May 25, 2015

Record last verified: 2015-05

Locations

ES (3)