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

NCT03108664 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 330

Last updated 2019-02-15

No results posted yet for this study

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.

Conditions

Interventions

DRUG

SYL1001 ophthalmic solution

1 drop in the affected eye

DRUG

Vehicle opthalmic solution

1 drop in the affected eye

Sponsors & Collaborators

  • Sylentis, S.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-18
Primary Completion
2018-10-16
Completion
2018-11-16

Countries

  • Estonia
  • Germany
  • Italy
  • Portugal
  • Slovakia
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03108664 on ClinicalTrials.gov