EBI: A Multi-Center Study Subjects With Dry Eye Syndrome

Sponsor

Eleven Biotherapeutics (Industry)

Overall Status

Completed

CT.gov ID

NCT01745887

Collaborator

(none)

Enrollment

Locations

Arms

9.3

Patients Per Site

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Drug: EBI-005-2	Phase 1

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 Design

Study Type:

Interventional

Actual Enrollment :

74 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, 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

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Nov 1, 2012

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

OSDI (Ocular Surface Disease Index) [2 months]
OSDI is a subject assessment tool to determine subject Dry Eye Syndrome symptoms

Secondary Outcome Measures

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

Other Outcome Measures

Gene transcription levels measured from cells collected via impression cytology [2 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Investigational Site	Artesia	California	United States	90701
2	Investigational Site	Ranchero Cordova	California	United States	95670
3	Investigational Site	Torrence	California	United States	90505
4	Investigational Site	Kansas City	Missouri	United States	64111
5	Investigational Site	Washington	Missouri	United States	63090
6	Investigational Site	Cleveland	Ohio	United States	44115
7	Investigational Site	San Antonio	Texas	United States	78209
8	Investigational Site	Norfolk	Virginia	United States	23502