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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.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Dry Eye Disease Drug: SYL1001 ophthalmic solution Drug: Vehicle opthalmic solution Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 330 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye
Actual Study Start Date : May 18, 2017
Actual Primary Completion Date : October 16, 2018
Actual Study Completion Date : November 16, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

Arms and Interventions
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Arm Intervention/treatment
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
 Drug: SYL1001 ophthalmic solution
1 drop in the affected eye
Experimental: Vehicle ophthalmic solution
1 drop of vehicle ophthalmic solution in the affected eye(s) q.d
 Drug: Vehicle opthalmic solution
1 drop in the affected eye


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Change from baseline in conjunctival hyperaemia scores based on the McMonnies scale as a measurement of SYL1001 effect versus vehicle [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability [ Time Frame: 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108664


Locations
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Sponsors and Collaborators
Sylentis, S.A.
More Information
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Responsible Party: Sylentis, S.A.
ClinicalTrials.gov Identifier: NCT03108664    
Other Study ID Numbers: SYL1001_IV
2016-003903-79 ( EudraCT Number )
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sylentis, S.A.:
SYL1001
siRNA
Additional relevant MeSH terms:
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Dry Eye Syndromes
Keratoconjunctivitis Sicca
Eye Diseases
Lacrimal Apparatus Diseases
Keratoconjunctivitis
Conjunctivitis
 Conjunctival Diseases
Keratitis
Corneal Diseases
Pharmaceutical Solutions
Ophthalmic Solutions