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

• ClinicalTrials.gov Identifier: NCT03108664
• Recruitment Status: Completed
• First Posted: April 11, 2017
• Last Update Posted: February 15, 2019
• Sponsor: Sylentis, S.A.
• Information provided by (Responsible Party): Sylentis, S.A.

Tracking Information

• First Submitted Date: March 30, 2017
• First Posted Date: April 11, 2017
• Last Update Posted Date: February 15, 2019
• Actual Study Start Date: May 18, 2017
• Actual Primary Completion Date: October 16, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures (submitted: April 5, 2017): Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability [ Time Frame: 28 days ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye Disease (DED)
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Dry Eye Disease

Intervention

• Drug: SYL1001 ophthalmic solution
  1 drop in the affected eye
• Drug: Vehicle opthalmic solution
  1 drop in the affected eye

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 12, 2019): 330
• Original Estimated Enrollment (submitted: April 5, 2017): 300
• Actual Study Completion Date: November 16, 2018
• Actual Primary Completion Date: October 16, 2018 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Estonia, Germany, Italy, Portugal, Slovakia, Spain

Administrative Information

• NCT Number: NCT03108664
• Other Study ID Numbers: 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: Not Provided
• Current Responsible Party: Sylentis, S.A.
• Original Responsible Party: Same as current
• Current Study Sponsor: Sylentis, S.A.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Sylentis, S.A.
• Verification Date: September 2018