A Multi-Center Study Subjects With Dry Eye Syndrome

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2012-11-30

Brief Summary

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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

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* 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.

Conditions

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Dry Eye Syndrome

Keywords

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Dry Eye Syndrome Interleukin 1 Receptor Inhibitor

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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EBI-005-2 5mg/ml

Administration: 3 times per day

Group Type ACTIVE_COMPARATOR

EBI-005-2

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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

* 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Goldstein, MD

Role: STUDY_DIRECTOR

Eleven Biotherapeutics

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EBI-005-2

Identifier Type: -

Identifier Source: org_study_id

A Multi-Center Study Subjects With Dry Eye Syndrome

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

EBI-005-2 5mg/ml

EBI-005-2

EBI-005-2 20 mg/ml

EBI-005-2

EBI-005-2 Placebo

Interventions

EBI-005-2

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Eleven Biotherapeutics

Responsible Party

Principal Investigators

Michael Goldstein, MD

Locations

Investigational Site

Investigational Site

Investigational Site

Investigational Site

Investigational Site

Investigational Site

Investigational Site

Investigational Site

Countries

Other Identifiers

EBI-005-2