HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye Disease (DED)
- Conditions
- Dry Eye Disease
- Interventions
- Drug: SYL1001 ophthalmic solutionDrug: Vehicle opthalmic solution
- Registration Number
- NCT03108664
- Lead Sponsor
- Sylentis, S.A.
- Brief Summary
The purpose of this study is to determine whether SYL1001 ophthalmic solution is safe and effective in the treatment of signs and symptoms of Dry Eye Disease.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 330
- Both genders
- ≥ 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 symptoms of persistent, daily, moderate to severe dry eye lasting more than six months.
- Use of artificial tears
- VAS scale for eye discomfort/pain between 30 - 80
- CFS ≥ 2 and ≤ 4 on the Oxford scale
- TBUT < 10 seconds
- Hyperemia score ≥ 1 (McMonnies scale)
- Schirmer's test without anesthesia ≥ 2 and < 10 mm/5min in the eye
- Corrected visual acuity ≥ 0.7 logMAR
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 11.25 mg/mL SYL1001 ophthalmic solution SYL1001 ophthalmic solution 1 drop of 11.25 mg/mL SYL1001 ophthalmic solution in the affected eye(s) q.d Vehicle ophthalmic solution Vehicle opthalmic solution 1 drop of vehicle ophthalmic solution in the affected eye(s) q.d
- Primary Outcome Measures
Name Time Method Change from baseline in Visual Analogue Scale (VAS) scores for eye discomfort/pain as a measurement of SYL1001 effect versus vehicle 28 days Change from baseline in Corneal Fluorescein Staining (CFS) total scores obtained on the Oxford scale as a measurement of SYL1001 effect versus vehicle 28 days Change from baseline in conjunctival hyperaemia scores based on the McMonnies scale as a measurement of SYL1001 effect versus vehicle 28 days
- Secondary Outcome Measures
Name Time Method Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability 28 days
Trial Locations
- Locations (40)
Augenzentrum Nord-West
🇩🇪Ahaus, Germany
AOU Careggi
🇮🇹Firenze, Italy
Farmacia Azienda Ospedaliera di Padova
🇮🇹Padova, Italy
Hospital Universitario la Paz
🇪🇸Madrid, Spain
Clínica Universidad de Navarra
🇪🇸Pamplona, Navarra, Spain
Hospital Universitario Fundación Jiménez Díaz
🇪🇸Madrid, Spain
OPHTHAMED, s.r.o.,
🇸🇰Žilina, Slovakia
East Tallin Central Hospital
🇪🇪Tallin, Estonia
Ospedale San Giuseppe
🇮🇹Milan, Italy
Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde
🇩🇪Leipzig, Germany
Hospital Universitario Príncipe de Asturias
🇪🇸Alcala de Henares, Madrid, Spain
Hospital Clínico San Carlos
🇪🇸Madrid, Spain
FISABIO Oftalmología Médica (FOM)
🇪🇸Valencia, Spain
Hospital Lusiadas Lisboa
🇵🇹Lisboa, Portugal
Instituto de Oftalmología del Hospital Clínic de Barcelona Casa de la Maternitat
🇪🇸Barcelona, Spain
Centro de Oftalmología Barraquer
🇪🇸Barcelona, Spain
Hospital Provincial Nuestra Señora de Gracia
🇪🇸Zaragoza, Spain
A.O.U. Pisana
🇮🇹Pisa, Italy
Augenklinik der Ludwig-Maximilian Universität München
🇩🇪Munchen, Germany
Hospital Universitario Ramón y Cajal
🇪🇸Madrid, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Tartu University Hospital
🇪🇪Tartu, Estonia
Eye Clinic Dr. Krista Turman
🇪🇪Tallinn, Estonia
Uniklinik Köln Zentrum für Augenheilkunde
🇩🇪Köln, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Universitäts-Augenklinik Düsseldorf
🇩🇪Dusseldorf, Germany
Universitätsklinikum des Saarlandes
🇩🇪Homburg, Germany
Klinik für Augenheilkunde Universitätsklinikum Schleswig-Holstein
🇩🇪Kiel, Germany
Hospital de Braga
🇵🇹Braga, Portugal
Instituto Oftalmológico Fernández Vega
🇪🇸Oviedo, Asturias, Spain
Institut Català de la Retina
🇪🇸Barcelona, Spain
Instituto de Microcirugía Ocular (IMO)
🇪🇸Barcelona, Spain
Hospital Clínico Universitario de Valladolid
🇪🇸Valladolid, Spain
VIKOM s.r.o
🇸🇰Žilina, Slovakia
Fakultná nemocnica s poliklinikou Žilina
🇸🇰Žilina, Slovakia
Centro Hospitalar e Universitário de Coimbra
🇵🇹Coimbra, Portugal
Bellet s.r.o
🇸🇰Martin, Slovakia
Oftalmologická ambulancia
🇸🇰Trenčín, Slovakia
Fakultná nemocnica Trenčín,
🇸🇰Trenčín, Slovakia
Optomedic s.r.o
🇸🇰Štúrovo, Slovakia