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

A Multi-Center, Double Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of EBI-005 Ophthalmic Solution Versus Placebo in Subjects With Dry Eye Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Syndrome
• Intervention / Treatment: Drug: EBI-005-2

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.

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Artesia, California, United States, 90701
      • Investigational Site
    • Ranchero Cordova, California, United States, 95670
      • Investigational Site
    • Torrence, California, United States, 90505
      • Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • Investigational Site
    • Washington, Missouri, United States, 63090
      • Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44115
      • Investigational Site
  • Texas
    • San Antonio, Texas, United States, 78209
      • Investigational Site
  • 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:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
OSDI (Ocular Surface Disease Index)	OSDI is a subject assessment tool to determine subject Dry Eye Syndrome symptoms	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in total corneal fluorescein staining	Corneal staining assessment will be performed using methods developed by the NEI Dry Eye Workshop.	2 months
Symptom Assessment in Dry Eye (Modified SANDE)	Patient Reported Outcome using a Visual Analog Scale for Modified SANDE.	2 months

Other Outcome Measures

Outcome Measure	Time Frame
Gene transcription levels measured from cells collected via impression cytology	2 months

Collaborators and Investigators

• Sponsor: Eleven Biotherapeutics

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): November 1, 2012
• Study Completion (ACTUAL): November 1, 2012

Study Registration Dates

• First Submitted: December 4, 2012
• First Submitted That Met QC Criteria: December 7, 2012
• First Posted (ESTIMATE): December 10, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 14, 2013
• Last Update Submitted That Met QC Criteria: August 13, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Dry Eye Syndrome; Interleukin 1 Receptor Inhibitor
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Syndrome; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: EBI-005-2