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Phase 3 Study of EBI-005 in Dry Eye Disease (EBI-005)

Primary Purpose

Dry Eye Disease (DED)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Active Comparator EBI-005
Placebo Comparator
Sponsored by
Eleven Biotherapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease (DED)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Give written informed consent and any authorizations required by local law (e.g., Protected Health Information waiver) prior to performing any study procedures;
  • Are ≥ 18 years of age;
  • Are willing and able to follow instructions and can be present for the required study visits for the duration of the study;
  • Have a history of dry eye disease (DED) in both eyes supported by a previous clinical diagnosis
  • Have normal lid anatomy.
  • If female and of child bearing potential, she must not be not pregnant or lactating and not sexually active (abstinent) within 14 days prior to Visit 1

Exclusion Criteria:

  • Have signs of infection (i.e., fever or current treatment with antibiotics)
  • Have been exposed to an investigational drug/device within the preceding 30 days
  • Be an employee of the site that is directly involved in the management, administration, or support of the study, or be an immediate family member of the same
  • Be unwilling to or unable to comply with the study

Sites / Locations

  • Investigational Site
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  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site#2
  • Investigational Site
  • Investigational Site
  • Investigational Site# 2
  • Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Comparator: EBI-005

Placebo Comparator

Arm Description

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.

One of two study arms: placebo topical administered 3 times per day.

Outcomes

Primary Outcome Measures

NEI score for Total Corneal Fluorescein Staining (TCFS)
To evaluate the efficacy of EBI-005 5 mg/mL topical ophthalmic solution given three times daily for 12 weeks as measured by the change in the NEI score for the Total Corneal Fluorescein Staining [sign] from baseline to Week 12 and a change in ocular pain as measured by the painful or sore eye question on the OSDI [symptom] of DED from baseline to Week 12 as compared to vehicle control.

Secondary Outcome Measures

The key secondary endpoint is total OSDI score
Change from baseline to week 12 in Total OSDI score.

Full Information

First Posted
November 25, 2013
Last Updated
June 10, 2015
Sponsor
Eleven Biotherapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01998802
Brief Title
Phase 3 Study of EBI-005 in Dry Eye Disease
Acronym
EBI-005
Official Title
A Multi-Center, Double-Masked, Randomized, Controlled, Efficacy and Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle Contraol In Subjects With Moderate to Severe Dry Eye Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eleven Biotherapeutics

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a phase III double-masked, randomized, controlled study evaluating the efficacy of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe DED three times daily for 12 weeks. Approximately 730 subjects at up to approximately 50 centers in the United States will be screened, enrolled into the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease (DED)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
670 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Comparator: EBI-005
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
One of two study arms: placebo topical administered 3 times per day.
Intervention Type
Drug
Intervention Name(s)
Active Comparator EBI-005
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Primary Outcome Measure Information:
Title
NEI score for Total Corneal Fluorescein Staining (TCFS)
Description
To evaluate the efficacy of EBI-005 5 mg/mL topical ophthalmic solution given three times daily for 12 weeks as measured by the change in the NEI score for the Total Corneal Fluorescein Staining [sign] from baseline to Week 12 and a change in ocular pain as measured by the painful or sore eye question on the OSDI [symptom] of DED from baseline to Week 12 as compared to vehicle control.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The key secondary endpoint is total OSDI score
Description
Change from baseline to week 12 in Total OSDI score.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Give written informed consent and any authorizations required by local law (e.g., Protected Health Information waiver) prior to performing any study procedures; Are ≥ 18 years of age; Are willing and able to follow instructions and can be present for the required study visits for the duration of the study; Have a history of dry eye disease (DED) in both eyes supported by a previous clinical diagnosis Have normal lid anatomy. If female and of child bearing potential, she must not be not pregnant or lactating and not sexually active (abstinent) within 14 days prior to Visit 1 Exclusion Criteria: Have signs of infection (i.e., fever or current treatment with antibiotics) Have been exposed to an investigational drug/device within the preceding 30 days Be an employee of the site that is directly involved in the management, administration, or support of the study, or be an immediate family member of the same Be unwilling to or unable to comply with the study
Facility Information:
Facility Name
Investigational Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Investigational Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85208
Country
United States
Facility Name
Investigational Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72212
Country
United States
Facility Name
Investigational Site
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Investigational Site
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Investigational Site
City
Petaluma
State/Province
California
ZIP/Postal Code
94954
Country
United States
Facility Name
Investigational Site
City
Rancho Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Investiational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92115
Country
United States
Facility Name
Investigational Site
City
Torrence
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Investigational Site
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Investigational Site
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Investigational Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Investigational Site
City
Roswell
State/Province
Georgia
ZIP/Postal Code
30076
Country
United States
Facility Name
Investigational Site
City
Bloomingdale
State/Province
Illinois
ZIP/Postal Code
60108
Country
United States
Facility Name
Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Investigational Site
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Investigational Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40217
Country
United States
Facility Name
Investigational Site
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Investigational Site
City
Winchester
State/Province
Massachusetts
ZIP/Postal Code
01890
Country
United States
Facility Name
Investigational Site
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Investigational Site
City
Des Peres
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
Investigational Site
City
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States
Facility Name
Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Investigational Site
City
Wantagh
State/Province
New York
ZIP/Postal Code
11793
Country
United States
Facility Name
Investigational Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Investigational Site
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Investigational Site
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Investigational Site
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77034
Country
United States
Facility Name
Investigational Site#2
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Investigational Site
City
League City
State/Province
Texas
ZIP/Postal Code
77573
Country
United States
Facility Name
Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Investigational Site# 2
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Phase 3 Study of EBI-005 in Dry Eye Disease

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