Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers

Phase I Study to Evaluate the Ocular Tolerance of SYL1001 in Healthy Volunteers

The purpose of this study is to determine whether SYL1001 is safe for the prevention and treatment of ocular pain and dry eye syndrome.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universidad de Navarra

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects must provide signed inform consent prior to participation.
• BMI between 19,5 y 29 kg/m2.
• Normal ocular test in both eyes: IOP </=21 mmHg. BCVAof >/=0,8 (20/25)Snellen scale, or </=0.1 LogMar.
• Normal fluorescein Clearance Test in both eyes.
• Normal funduscopy in both eyes.

Exclusion Criteria:

• Pregnant or breastfeeding females or those with a positive pregnancy test or who will not use a medically acceptable contraceptive method from selection and during the study.
• Current relevant disease.
• Previous chronic processes or with rebound characteristics that could interfere with study according investigator's judgment.
• Volunteers who have received pharmacological treatment, including medicinal plants, during the four weeks previous to beginning the study.
• Having used corticoids sporadically in the last 30 days whichever the route aof administration, or any med by ocular or nasal administration route.
• Case history of hypersensitivity to meds or any other allergic process.
• Visual alterations: previous eye surgery, glaucoma, use of lenses, uveitis or ocular surface pathology (dry eye, blepharitis).
• Volunteers with visual alteration with more than 3 dioptres in either eye.
• Volunteers who has participated in a clinical trial during the past fout months before study entry.
• Blood or derivate transfusion during the six previous months to study entry.
• Case history of drug or alcohol abuse or dependence.
• Positive result in test drug abuse during selection period.
• positive serology results to hepatitis B virus(HbsAg), virus C o VIH.
• Analytic alterations medically relevant, at investigator's judgement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: SINGLE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: SYL1001	Drug: SYL1001; SYL1001 eye drops. topical administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local tolerance assessment of cornea and conjunctival sac after administration of one dose of SYL1001 for period 1 and after 7 days of administration of SYL1001 with one dose per day for period 2.	Local tolerance and ocular surface (cornea and conjunctival) on the area of administration 24 hours after last administration. It will be performed using a slit lamp which will be performed before, during and after the administration at established times. Adverse events will be registered and the determination of subjective tolerance will use the visual analogical scale in cases where asubjects refers them	Period I: 3 days, Period II: 11 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General tolerance assessment after administration of one dose of SYL1001 (period 1) and after 7 days administration (period 2)	Corneal pachymetry eye exploration BCVA (best corrected visual acuity) eye fundus evaluation Clinical exploration Side effects	Period I: 3 days; Period II: 11 days

Collaborators and Investigators

• Sponsor: Sylentis, S.A.
• Investigators: Principal Investigator: Belen Sadaba, MD, PhD, Clinica Universidad de Navarra

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: July 1, 2011
• Primary Completion (ACTUAL): November 1, 2011
• Study Completion (ACTUAL): June 1, 2012

Study Registration Dates

• First Submitted: September 14, 2011
• First Submitted That Met QC Criteria: September 21, 2011
• First Posted (ESTIMATE): September 22, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): July 17, 2012
• Last Update Submitted That Met QC Criteria: July 16, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: dry eye; siRNA; ocular pain
• Additional Relevant MeSH Terms: Eye Diseases; Pain; Neurologic Manifestations; Lacrimal Apparatus Diseases; Eye Manifestations; Dry Eye Syndromes; Eye Pain
• Other Study ID Numbers: SYL1001_I; 2010-023113-56 (EUDRACT_NUMBER)