Phase 3 Study of EBI-005 in Dry Eye Disease

Last updated: June 10, 2015
Sponsor: Eleven Biotherapeutics
Overall Status: Completed

Phase

3

Condition

Sjogren's Syndrome

Dry Eye Disease

Dry Eyes

Treatment

N/A

Clinical Study ID

NCT01998802
EBI-005-3
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 studyvisits for the duration of the study;

  • Have a history of dry eye disease (DED) in both eyes supported by a previous clinicaldiagnosis

  • Have normal lid anatomy.

  • If female and of child bearing potential, she must not be not pregnant or lactatingand not sexually active (abstinent) within 14 days prior to Visit 1

Exclusion

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 Design

Total Participants: 670
Study Start date:
January 01, 2014
Estimated Completion Date:
April 30, 2015

Connect with a study center

  • Investigational Site

    Chandler, Arizona 85225
    United States

    Site Not Available

  • Investigational Site

    Mesa, Arizona 85208
    United States

    Site Not Available

  • Investigational Site

    Little Rock, Arkansas 72212
    United States

    Site Not Available

  • Investigational Site

    Artesia, California 90701
    United States

    Site Not Available

  • Investigational Site

    Mission Hills, California 91345
    United States

    Site Not Available

  • Investigational Site

    Petaluma, California 94954
    United States

    Site Not Available

  • Investigational Site

    Rancho Cordova, California 95670
    United States

    Site Not Available

  • Investiational Site

    San Diego, California 92115
    United States

    Site Not Available

  • Investigational Site

    Torrance, California 90505
    United States

    Site Not Available

  • Investigational Site

    Torrence, California 90505
    United States

    Site Not Available

  • Investigational Site

    Littleton, Colorado 80120
    United States

    Site Not Available

  • Investigational Site

    Hamden, Connecticut 06518
    United States

    Site Not Available

  • Investigational Site

    Plantation, Florida 33324
    United States

    Site Not Available

  • Investigational Site

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Investigational Site

    Bloomingdale, Illinois 60108
    United States

    Site Not Available

  • Investigational Site

    Indianapolis, Indiana 46290
    United States

    Site Not Available

  • Investigational Site

    New Albany, Indiana 47150
    United States

    Site Not Available

  • Investigational Site

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Investigational Site

    Louisville, Kentucky 40206
    United States

    Site Not Available

  • Investigational Site

    Bangor, Maine 04401
    United States

    Site Not Available

  • Investigational Site

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Investigational Site

    Winchester, Massachusetts 01890
    United States

    Site Not Available

  • Investigational Site

    Chesterfield, Missouri 63017
    United States

    Site Not Available

  • Investigational Site

    Des Peres, Missouri 63131
    United States

    Site Not Available

  • Investigational Site

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Investigational Site

    St. Louis, Missouri 63131
    United States

    Site Not Available

  • Investigational Site

    Washington, Missouri 63090
    United States

    Site Not Available

  • Investigational Site

    Las Vegas, Nevada 89148
    United States

    Site Not Available

  • Investigational Site

    New York, New York 10036
    United States

    Site Not Available

  • Investigational Site

    Rochester, New York 14618
    United States

    Site Not Available

  • Investigational Site

    Wantagh, New York 11793
    United States

    Site Not Available

  • Investigational Site

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Investigational Site

    Cleveland, Ohio 44115
    United States

    Site Not Available

  • Investigational Site

    Cranberry Township, Pennsylvania 16066
    United States

    Site Not Available

  • Investigational Site

    Lancaster, Pennsylvania 17601
    United States

    Site Not Available

  • Investigational Site

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Investigational Site

    Rapid City, South Dakota 57701
    United States

    Site Not Available

  • Investigational Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • Investigational Site

    Houston, Texas 77034
    United States

    Site Not Available

  • Investigational Site#2

    Houston, Texas 77055
    United States

    Site Not Available

  • Investigational Site

    League City, Texas 77573
    United States

    Site Not Available

  • Investigational Site

    San Antonio, Texas 78209
    United States

    Site Not Available

  • Investigational Site# 2

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Investigational Site

    Norfolk, Virginia 23502
    United States

    Site Not Available

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