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.