- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03108664
HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye Disease (DED)
February 12, 2019 updated by: Sylentis, S.A.
HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
330
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tallin, Estonia, 10138
- East Tallin Central Hospital
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Tallinn, Estonia, 13419
- Eye Clinic Dr. Krista Turman
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Tartu, Estonia, 50406
- Tartu University Hospital
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Ahaus, Germany, 48683
- Augenzentrum Nord-West
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Dusseldorf, Germany, 40225
- Universitäts-Augenklinik Düsseldorf
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Freiburg, Germany
- Universitätsklinikum Freiburg
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Homburg, Germany
- Universitätsklinikum des Saarlandes
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Kiel, Germany
- Klinik für Augenheilkunde Universitätsklinikum Schleswig-Holstein
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Köln, Germany
- Uniklinik Köln Zentrum für Augenheilkunde
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Leipzig, Germany
- Universitätsklinikum Leipzig AöR Klinik und Poliklinik für Augenheilkunde
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Munchen, Germany, 80336
- Augenklinik der Ludwig-Maximilian Universität München
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Firenze, Italy
- AOU Careggi
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Milan, Italy
- Ospedale San Giuseppe
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Padova, Italy
- Farmacia Azienda Ospedaliera di Padova
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Pisa, Italy
- A.O.U. Pisana
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Braga, Portugal, 4710-243
- Hospital de Braga
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Coimbra, Portugal
- Centro Hospitalar e Universitário de Coimbra
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Lisboa, Portugal, 1500-461
- Hospital Lusiadas Lisboa
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Martin, Slovakia, 03601
- Bellet s.r.o
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Trenčín, Slovakia, 911 01
- Oftalmologická ambulancia
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Trenčín, Slovakia, 911 71
- Fakultná nemocnica Trenčín,
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Štúrovo, Slovakia, 943 01
- Optomedic s.r.o
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Žilina, Slovakia, 012 07
- Fakultna nemocnica s poliklinikou Zilina
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Žilina, Slovakia, 01 001
- OPHTHAMED, s.r.o.,
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Žilina, Slovakia, 010 08
- VIKOM s.r.o
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Barcelona, Spain, 08017
- Institut Catala de La Retina
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Barcelona, Spain
- Centro de Oftalmologia Barraquer
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Barcelona, Spain, 08028
- Instituto de Oftalmología del Hospital Clínic de Barcelona Casa de la Maternitat
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Barcelona, Spain, 08035
- Instituto de Microcirugía Ocular (IMO)
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Madrid, Spain, 28040
- Hospital Clinico San Carlos
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Madrid, Spain, 28040
- Hospital Universitario Fundacion Jimenez Diaz
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Madrid, Spain, 28046
- Hospital Universitario La Paz
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Madrid, Spain, 28043
- Hospital Universitario Ramón y Cajal
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Sevilla, Spain, 41009
- Hospital Universitario Virgen Macarena
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Valencia, Spain, 46017
- FISABIO Oftalmología Médica (FOM)
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Valladolid, Spain
- Hospital Clínico Universitario de Valladolid
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Zaragoza, Spain, 50004
- Hospital Provincial Nuestra Señora de Gracia
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Asturias
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Oviedo, Asturias, Spain, 33012
- Instituto Oftalmologico Fernandez Vega
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Madrid
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Alcala de Henares, Madrid, Spain, 28805
- Hospital Universitario Príncipe de Asturias
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Navarra
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Pamplona, Navarra, Spain, 31008
- Clinica Universidad de Navarra
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 11.25 mg/mL SYL1001 ophthalmic solution
1 drop of 11.25 mg/mL SYL1001 ophthalmic solution in the affected eye(s) q.d
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1 drop in the affected eye
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EXPERIMENTAL: Vehicle ophthalmic solution
1 drop of vehicle ophthalmic solution in the affected eye(s) q.d
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1 drop in the affected eye
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in Visual Analogue Scale (VAS) scores for eye discomfort/pain as a measurement of SYL1001 effect versus vehicle
Time Frame: 28 days
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28 days
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Change from baseline in Corneal Fluorescein Staining (CFS) total scores obtained on the Oxford scale as a measurement of SYL1001 effect versus vehicle
Time Frame: 28 days
|
28 days
|
Change from baseline in conjunctival hyperaemia scores based on the McMonnies scale as a measurement of SYL1001 effect versus vehicle
Time Frame: 28 days
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
May 18, 2017
Primary Completion (ACTUAL)
October 16, 2018
Study Completion (ACTUAL)
November 16, 2018
Study Registration Dates
First Submitted
March 30, 2017
First Submitted That Met QC Criteria
April 5, 2017
First Posted (ACTUAL)
April 11, 2017
Study Record Updates
Last Update Posted (ACTUAL)
February 15, 2019
Last Update Submitted That Met QC Criteria
February 12, 2019
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SYL1001_IV
- 2016-003903-79 (EUDRACT_NUMBER)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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