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

Sylentis

Status and phase

Completed

Phase 3

Conditions

Dry Eye Disease

Treatments

Drug: SYL1001 ophthalmic solution

Drug: Vehicle opthalmic solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT03108664

SYL1001_IV

2016-003903-79 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

330 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.