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

Primary Purpose

Dry Eye Syndrome

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EBI-005-2
Sponsored by
Eleven Biotherapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Syndrome focused on measuring Dry Eye Syndrome, Interleukin 1 Receptor Inhibitor

Eligibility Criteria

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

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).

Sites / Locations

  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

EBI-005-2 5mg/ml

EBI-005-2 20 mg/ml

EBI-005-2 Placebo

Arm Description

Administration: 3 times per day

Administration: 3 times per day

Administration: 3 times per day

Outcomes

Primary Outcome Measures

OSDI (Ocular Surface Disease Index)
OSDI is a subject assessment tool to determine subject Dry Eye Syndrome symptoms

Secondary Outcome Measures

Change from baseline in total corneal fluorescein staining
Corneal staining assessment will be performed using methods developed by the NEI Dry Eye Workshop.
Symptom Assessment in Dry Eye (Modified SANDE)
Patient Reported Outcome using a Visual Analog Scale for Modified SANDE.

Full Information

First Posted
December 4, 2012
Last Updated
August 13, 2013
Sponsor
Eleven Biotherapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT01745887
Brief Title
A Multi-Center Study Subjects With Dry Eye Syndrome
Acronym
EBI
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndrome
Keywords
Dry Eye Syndrome, Interleukin 1 Receptor Inhibitor

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EBI-005-2 5mg/ml
Arm Type
Active Comparator
Arm Description
Administration: 3 times per day
Arm Title
EBI-005-2 20 mg/ml
Arm Type
Active Comparator
Arm Description
Administration: 3 times per day
Arm Title
EBI-005-2 Placebo
Arm Type
Placebo Comparator
Arm Description
Administration: 3 times per day
Intervention Type
Drug
Intervention Name(s)
EBI-005-2
Intervention Description
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.
Primary Outcome Measure Information:
Title
OSDI (Ocular Surface Disease Index)
Description
OSDI is a subject assessment tool to determine subject Dry Eye Syndrome symptoms
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Change from baseline in total corneal fluorescein staining
Description
Corneal staining assessment will be performed using methods developed by the NEI Dry Eye Workshop.
Time Frame
2 months
Title
Symptom Assessment in Dry Eye (Modified SANDE)
Description
Patient Reported Outcome using a Visual Analog Scale for Modified SANDE.
Time Frame
2 months
Other Pre-specified Outcome Measures:
Title
Gene transcription levels measured from cells collected via impression cytology
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: A score of ≥23 on OSDI 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Goldstein, MD
Organizational Affiliation
Eleven Biotherapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site
City
Artesia
State/Province
California
ZIP/Postal Code
90701
Country
United States
Facility Name
Investigational Site
City
Ranchero Cordova
State/Province
California
ZIP/Postal Code
95670
Country
United States
Facility Name
Investigational Site
City
Torrence
State/Province
California
ZIP/Postal Code
90505
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
Washington
State/Province
Missouri
ZIP/Postal Code
63090
Country
United States
Facility Name
Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44115
Country
United States
Facility Name
Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

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A Multi-Center Study Subjects With Dry Eye Syndrome

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