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A Multi-Center Study Subjects With Dry Eye Syndrome (EBI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eleven Biotherapeutics
ClinicalTrials.gov Identifier:
NCT01745887
First received: December 4, 2012
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

This is a Phase 1b, multi-center, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the safety and biological activity of two doses of EBI-005 ophthalmic solution versus placebo in subjects with moderate to severe Dry Eye Syndrome. Approximately 72 subjects will be enrolled and randomized in this study at up to 9 centers located in the United States (US). Subjects will be enrolled in two groups or cohorts. The first enrollment group will consist of 33 subjects.


Condition Intervention Phase
Dry Eye Syndrome
Drug: EBI-005-2
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Double Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of EBI-005 Ophthalmic Solution Versus Placebo in Subjects With Dry Eye Syndrome

Resource links provided by NLM:


Further study details as provided by Eleven Biotherapeutics:

Primary Outcome Measures:
  • OSDI (Ocular Surface Disease Index) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    OSDI is a subject assessment tool to determine subject Dry Eye Syndrome symptoms


Secondary Outcome Measures:
  • Change from baseline in total corneal fluorescein staining [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Corneal staining assessment will be performed using methods developed by the NEI Dry Eye Workshop.

  • Symptom Assessment in Dry Eye (Modified SANDE) [ Time Frame: 2 months ] [ Designated as safety issue: No ]
    Patient Reported Outcome using a Visual Analog Scale for Modified SANDE.


Other Outcome Measures:
  • Gene transcription levels measured from cells collected via impression cytology [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: November 2012
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: EBI-005-2 5mg/ml
Administration: 3 times per day
Drug: EBI-005-2
The investigational drug EBI-005-2, is an intervention to three different study arms. One arm gets 5mg/ml, the other gets 20mg/ml and the last arm is Placebo.
Active Comparator: EBI-005-2 20 mg/ml
Administration: 3 times per day
Drug: EBI-005-2
The investigational drug EBI-005-2, is an intervention to three different study arms. One arm gets 5mg/ml, the other gets 20mg/ml and the last arm is Placebo.
Placebo Comparator: EBI-005-2 Placebo
Administration: 3 times per day

Detailed Description:
  • To investigate the safety and tolerability of EBI-005 ophthalmic solution compared to placebo in the treatment of patients with moderate to severe Dry Eye Syndrome (DES).
  • To evaluate pharmacokinetic (PK) parameters and immunogenicity of two different doses of EBI-005 ophthalmic solution.
  • To investigate the biological activity of multiple doses of EBI-005 ophthalmic solution compared to placebo as assessed by both objective and subjective assessments.
  • To investigate the comparative dose response of two different doses of EBI-005 ophthalmic solution.
  • To investigate the comparative tolerability of two different doses of EBI-005 ophthalmic solution.
  • To identify key biomarkers in the diagnosis and management of subjects with DES.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Provide written informed consent prior to any study related procedures
  • Are 18 years of age or older
  • Are women of child bearing potential (WOCBP) who are non-pregnant, non-lactating and sexually inactive (abstinent) for 14 days 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
  • Have a history of Dry Eye Syndrome in both eyes supported by a previous clinical diagnosis
  • Have ongoing Dry Eye Syndrome, in the same eye or both eyes, as defined by the following criteria:

    1. A score of ≥23 on OSDI
    2. A corneal fluorescein staining score of ≥6 (NEI scale)
  • Have normal lid anatomy
  • Are willing to withhold artificial tears for the duration of the study, with the exception of the study provided artificial tears: Refresh Plus®.

Exclusion Criteria: Subjects may not:

  • Have previously used an IL-1 blocker (e.g., Anakinra, Rilonacept or Ilaris).
  • Have an OSDI score ≥90
  • Have a corneal fluorescein staining score of 15 (NEI scale). NOTE: If one of two eyes has a corneal fluorescein staining score of 15, the subject may be eligible.
  • Within 30 days prior to the screening visit (Visit 1) have taken: Topical cyclosporine (Restasis®) Ocular corticosteroids Autologous serum Topical ocular antibiotics Topical ocular antihistamines or mast cell stabilizers Topical or nasal vasoconstrictors
  • Within 30 days prior to the screening visit (Visit 1) have altered the dose of tetracycline compounds (tetracycline, doxycycline or minocycline).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01745887

Locations
United States, California
Investigational Site
Artesia, California, United States, 90701
Investigational Site
Ranchero Cordova, California, United States, 95670
Investigational Site
Torrence, California, United States, 90505
United States, Missouri
Investigational Site
Kansas City, Missouri, United States, 64111
Investigational Site
Washington, Missouri, United States, 63090
United States, Ohio
Investigational Site
Cleveland, Ohio, United States, 44115
United States, Texas
Investigational Site
San Antonio, Texas, United States, 78209
United States, Virginia
Investigational Site
Norfolk, Virginia, United States, 23502
Sponsors and Collaborators
Eleven Biotherapeutics
Investigators
Study Director: Michael Goldstein, MD Eleven Biotherapeutics
  More Information

No publications provided

Responsible Party: Eleven Biotherapeutics
ClinicalTrials.gov Identifier: NCT01745887     History of Changes
Other Study ID Numbers: EBI-005-2
Study First Received: December 4, 2012
Last Updated: August 13, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Eleven Biotherapeutics:
Dry Eye Syndrome
Interleukin 1 Receptor Inhibitor

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Syndrome
Conjunctival Diseases
Conjunctivitis
Corneal Diseases
Disease
Eye Diseases
Keratitis
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on November 20, 2014