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Monoclonal Antibodies

Active Comparator: EBI-005 for Dry Eye Syndrome (EBI-005 Trial)

Phase 3
Waitlist Available
Research Sponsored by Eleven Biotherapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

EBI-005 Trial 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.

Eligible Conditions
  • Dry Eye Syndrome

EBI-005 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Immunogenicity of EBI-005 (assessment of antibody development (immunogenicity) over time)
Safety of EBI-005 (laboratory changes over time)
Safety of EBI-005 (vital signs)
+1 more
Secondary outcome measures
Biological effect of EBI-005 (Changes over time in the OSDI)
Biological effect of EBI-005 (Total corneal fluorescein staining)

EBI-005 Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Active Comparator: EBI-005Active Control1 Intervention
Drug: EBI-005 The investigational drug EBI-005, is an intervention to one of two study arms: 5 mg/mL topical administered 3 times per day
Group II: Placebo or Vehicle control ComparatorPlacebo Group1 Intervention
One of two study arms: placebo or vehicle control topical administered 3 times per day

Find a Location

Who is running the clinical trial?

Eleven BiotherapeuticsLead Sponsor
6 Previous Clinical Trials
1,160 Total Patients Enrolled
Michael Goldstein, MDStudy DirectorEleven Biotherapeutics
4 Previous Clinical Trials
490 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who else is applying?

What state do they live in?
Connecticut
Tennessee
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
Study of EBI-005 in Dry Eye Disease (DED)
2015. "Study of EBI-005 in Dry Eye Disease (DED)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02405039.
All > Dry Eye
~19 spots leftby May 2025
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