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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01998802
Recruitment Status : Completed
First Posted : December 2, 2013
Last Update Posted : June 11, 2015
Information provided by (Responsible Party):
Eleven Biotherapeutics

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.

Condition or disease Intervention/treatment Phase
Dry Eye Disease (DED) Drug: Active Comparator EBI-005 Drug: Placebo Comparator Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 670 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : January 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Diseases

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

Primary Outcome Measures :
  1. NEI score for Total Corneal Fluorescein Staining (TCFS) [ Time Frame: 3 months ]
    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 :
  1. The key secondary endpoint is total OSDI score [ Time Frame: 3 months ]
    Change from baseline to week 12 in Total OSDI score.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01998802

  Show 45 Study Locations
Sponsors and Collaborators
Eleven Biotherapeutics

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Responsible Party: Eleven Biotherapeutics Identifier: NCT01998802     History of Changes
Other Study ID Numbers: EBI-005-3
First Posted: December 2, 2013    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Eye Diseases
Conjunctival Diseases
Corneal Diseases
Lacrimal Apparatus Diseases