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HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye Disease (DED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03108664
Recruitment Status : Completed
First Posted : April 11, 2017
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Sylentis, S.A.

Tracking Information
First Submitted Date  ICMJE March 30, 2017
First Posted Date  ICMJE April 11, 2017
Last Update Posted Date February 15, 2019
Actual Study Start Date  ICMJE May 18, 2017
Actual Primary Completion Date October 16, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
  • 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 ]
  • 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 ]
  • Change from baseline in conjunctival hyperaemia scores based on the McMonnies scale as a measurement of SYL1001 effect versus vehicle [ Time Frame: 28 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 5, 2017)
Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability [ Time Frame: 28 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye Disease (DED)
Official Title  ICMJE HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dry Eye Disease
Intervention  ICMJE
  • Drug: SYL1001 ophthalmic solution
    1 drop in the affected eye
  • Drug: Vehicle opthalmic solution
    1 drop in the affected eye
Study Arms  ICMJE
  • 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
    Intervention: Drug: SYL1001 ophthalmic solution
  • Experimental: Vehicle ophthalmic solution
    1 drop of vehicle ophthalmic solution in the affected eye(s) q.d
    Intervention: Drug: Vehicle opthalmic solution
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 12, 2019)
330
Original Estimated Enrollment  ICMJE
 (submitted: April 5, 2017)
300
Actual Study Completion Date  ICMJE November 16, 2018
Actual Primary Completion Date October 16, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Estonia,   Germany,   Italy,   Portugal,   Slovakia,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03108664
Other Study ID Numbers  ICMJE SYL1001_IV
2016-003903-79 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Sylentis, S.A.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Sylentis, S.A.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Sylentis, S.A.
Verification Date September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP