NCT02405039

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
188

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2015

Shorter than P25 for phase_3

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2015

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

April 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

1.2 years

First QC Date

January 6, 2015

Last Update Submit

June 2, 2015

Conditions

Dry Eye

Keywords

DEDDisease

Outcome Measures

Primary Outcomes (4)

  • Safety of EBI-005 (vital signs)

    Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time.

    1 year

  • tolerability of EBI-005 (adverse events)

    Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time.

    1 year

  • Immunogenicity of EBI-005 (assessment of antibody development (immunogenicity) over time)

    Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time.

    1 year

  • Safety of EBI-005 (laboratory changes over time)

    1 year

Secondary Outcomes (2)

  • Biological effect of EBI-005 (Changes over time in the OSDI)

    1 year

  • Biological effect of EBI-005 (Total corneal fluorescein staining)

    1 year

Study Arms (2)

Active Comparator: EBI-005

ACTIVE COMPARATOR

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

Drug: EBI-005

Placebo or Vehicle control Comparator

PLACEBO COMPARATOR

One of two study arms: placebo or vehicle control topical administered 3 times per day

Drug: Placebo

Interventions

EBI-005DRUG

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

Active Comparator: EBI-005
PlaceboDRUG

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

Placebo or Vehicle control Comparator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a history of dry eye disease (DED) in both eyes supported by a previous clinical diagnosis or have a self-reported history of subjective complaints for at least 6 months prior to Visit 1
  • Are willing and able to follow instructions and can be present for the required study visits for the duration of the study

You may not qualify if:

  • Have an ocular condition that could confound study assessments (ocular infection, herpetic or neurotrophic keratitis, Steven-Johnson Syndrome, etc)
  • Have had penetrating intraocular surgery within 12 months prior to Visit 1
  • Be unwilling to comply with the study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Unknown Facility

Birmingham, Alabama, 35294, United States

Location

Unknown Facility

Newport Beach, California, 92663, United States

Location

Unknown Facility

Hamden, Connecticut, 06518, United States

Location

Unknown Facility

New Albany, Indiana, 47150, United States

Location

Unknown Facility

Louisville, Kentucky, 40206, United States

Location

Unknown Facility

Winchester, Massachusetts, 01890, United States

Location

Unknown Facility

St Louis, Missouri, 63131, United States

Location

Unknown Facility

Asheville, North Carolina, 28803, United States

Location

Unknown Facility

Mason, Ohio, 45040, United States

Location

Unknown Facility

Cranberry Township, Pennsylvania, 16066, United States

Location

Unknown Facility

Memphis, Tennessee, 38119, United States

Location

Unknown Facility

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Dry Eye SyndromesDisease

Interventions

EBI-005

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Goldstein, MD

    Eleven Biotherapeutics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2015

First Posted

April 1, 2015

Study Start

April 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2016

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations

US(12)