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Study of EBI-005 in Dry Eye Disease (DED)

NCT02405039 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 188

Last updated 2015-06-04

No results posted yet for this study

Summary

This is a randomized, double masked study designed to evaluate the safety of EBI-005 5 mg/mL topical ophthalmic solution given three times daily (TID) compared to vehicle-control over a one year period in subjects with dry eye disease (DED). Approximately 188 subjects will be enrolled to either EBI-005 or vehicle at up to 15 centers in the United States (US) and Canada.

Conditions

  • Dry Eye

Interventions

DRUG

EBI-005

EBI-005 is an intervention into one of two (2) study arms; 5 mg/mL topical administered 3 times per day

DRUG

Placebo

Placebo or Vehicle control comparator is an intervention into one of two (2) study arms; vehicle topical administered 3 times per day

Sponsors & Collaborators

  • Eleven Biotherapeutics

    lead INDUSTRY

Principal Investigators

  • Michael Goldstein, MD · Eleven Biotherapeutics

Study Design

Allocation
RANDOMIZED
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-06-30
Completion
2016-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02405039 on ClinicalTrials.gov