Overview

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

Status:
Completed
Trial end date:
2018-11-16
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sylentis, S.A.
Treatments:
Ophthalmic Solutions
Pharmaceutical Solutions
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.