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

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

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease (DED)
• Intervention / Treatment: Drug: Placebo Comparator; Drug: Active Comparator EBI-005

• Study Type: Interventional
• Enrollment (Actual): 670
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Investigational Site
    • Mesa, Arizona, United States, 85208
      • Investigational Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72212
      • Investigational Site
  • California
    • Artesia, California, United States, 90701
      • Investigational Site
    • Mission Hills, California, United States, 91345
      • Investigational Site
    • Petaluma, California, United States, 94954
      • Investigational Site
    • Rancho Cordova, California, United States, 95670
      • Investigational Site
    • San Diego, California, United States, 92115
      • Investiational Site
    • Torrence, California, United States, 90505
      • Investigational Site
  • Colorado
    • Littleton, Colorado, United States, 80120
      • Investigational Site
  • Connecticut
    • Hamden, Connecticut, United States, 06518
      • Investigational Site
  • Florida
    • Plantation, Florida, United States, 33324
      • Investigational Site
  • Georgia
    • Roswell, Georgia, United States, 30076
      • Investigational Site
  • Illinois
    • Bloomingdale, Illinois, United States, 60108
      • Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Investigational Site
    • Indianapolis, Indiana, United States, 46290
      • Investigational Site
    • New Albany, Indiana, United States, 47150
      • Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Investigational Site
    • Louisville, Kentucky, United States, 40217
      • Investigational Site
    • Louisville, Kentucky, United States, 40206
      • Investigational Site
  • Maine
    • Bangor, Maine, United States, 04401
      • Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Investigational Site
    • Winchester, Massachusetts, United States, 01890
      • Investigational Site
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Investigational Site
    • Des Peres, Missouri, United States, 63131
      • Investigational Site
    • Kansas City, Missouri, United States, 64111
      • Investigational Site
    • St. Louis, Missouri, United States, 63131
      • Investigational Site
    • Washington, Missouri, United States, 63090
      • Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • Investigational Site
  • New York
    • New York, New York, United States, 10036
      • Investigational Site
    • Rochester, New York, United States, 14618
      • Investigational Site
    • Wantagh, New York, United States, 11793
      • Investigational Site
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44115
      • Investigational Site
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • Investigational Site
    • Lancaster, Pennsylvania, United States, 17601
      • Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • Investigational Site
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Investigational Site
  • Texas
    • Houston, Texas, United States, 77034
      • Investigational Site
    • Houston, Texas, United States, 77055
      • Investigational Site#2
    • League City, Texas, United States, 77573
      • Investigational Site
    • San Antonio, Texas, United States, 78209
      • Investigational Site
    • San Antonio, Texas, United States, 78229
      • Investigational Site# 2
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Comparator: EBI-005; 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: Active Comparator EBI-005
Placebo Comparator: Placebo Comparator; One of two study arms: placebo topical administered 3 times per day.	Drug: Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The key secondary endpoint is total OSDI score	Change from baseline to week 12 in Total OSDI score.	3 months

Collaborators and Investigators

• Sponsor: Eleven Biotherapeutics

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: November 25, 2013
• First Submitted That Met QC Criteria: November 25, 2013
• First Posted (Estimate): December 2, 2013

Study Record Updates

• Last Update Posted (Estimate): June 11, 2015
• Last Update Submitted That Met QC Criteria: June 10, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: EBI-005-3