HELIX, a Double-masked Study of SYL1001 in Patients With Moderate to Severe Dry Eye Disease (DED)
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|ClinicalTrials.gov Identifier: NCT03108664|
Recruitment Status : Completed
First Posted : April 11, 2017
Last Update Posted : February 15, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Disease||Drug: SYL1001 ophthalmic solution Drug: Vehicle opthalmic solution||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
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
- 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 ]
- Assessment of Adverse Events Appearance as a measure of SYL1001 tolerability [ Time Frame: 28 days ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
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
|Responsible Party:||Sylentis, S.A.|
|Other Study ID Numbers:||
2016-003903-79 ( EudraCT Number )
|First Posted:||April 11, 2017 Key Record Dates|
|Last Update Posted:||February 15, 2019|
|Last Verified:||September 2018|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Dry Eye Syndromes
Lacrimal Apparatus Diseases