A Multi-Center Study Subjects With Dry Eye Syndrome

Dry Eye Syndrome Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01745887
• Other study ID #: EBI-005-2
• Status: Completed
• Phase: Phase 1
• First received: December 4, 2012
• Last updated: August 13, 2013
• Start date: November 2012
• Est. completion date: November 2012

Study information

• Verified date: August 2013
• Source: Eleven Biotherapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndrome
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Investigational Site	Artesia	California
United States	Investigational Site	Cleveland	Ohio
United States	Investigational Site	Kansas City	Missouri
United States	Investigational Site	Norfolk	Virginia
United States	Investigational Site	Ranchero Cordova	California
United States	Investigational Site	San Antonio	Texas
United States	Investigational Site	Torrence	California
United States	Investigational Site	Washington	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Eleven Biotherapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gene transcription levels measured from cells collected via impression cytology		2 months	No
Primary	OSDI (Ocular Surface Disease Index)	OSDI is a subject assessment tool to determine subject Dry Eye Syndrome symptoms	2 months	No
Secondary	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	No
Secondary	Symptom Assessment in Dry Eye (Modified SANDE)	Patient Reported Outcome using a Visual Analog Scale for Modified SANDE.	2 months	No