Phase 3 Study of EBI-005 in Dry Eye Disease

Dry Eye Disease (DED) Clinical Trial

— EBI-005  

Official title:

A Multi-Center, Double-Masked, Randomized, Controlled, Efficacy and Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle Contraol In Subjects With Moderate to Severe Dry Eye Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998802
• Other study ID #: EBI-005-3
• Status: Completed
• Phase: Phase 3
• First received: November 25, 2013
• Last updated: June 10, 2015
• Start date: January 2014
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• 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 III double-masked, randomized, controlled study evaluating the efficacy of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe DED three times daily for 12 weeks. Approximately 730 subjects at up to approximately 50 centers in the United States will be screened, enrolled into the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 670
• Est. completion date: April 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Give written informed consent and any authorizations required by local law (e.g., Protected Health Information waiver) prior to performing any study procedures;

• Are = 18 years of age;

• 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 disease (DED) in both eyes supported by a previous clinical diagnosis

• Have normal lid anatomy.

• If female and of child bearing potential, she must not be not pregnant or lactating and not sexually active (abstinent) within 14 days prior to Visit 1

Exclusion Criteria:

• Have signs of infection (i.e., fever or current treatment with antibiotics)

• Have been exposed to an investigational drug/device within the preceding 30 days

• Be an employee of the site that is directly involved in the management, administration, or support of the study, or be an immediate family member of the same

• Be unwilling to or unable to comply with the study

Study Design

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

Related Conditions & MeSH terms

• Dry Eye Disease (DED)
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Active Comparator EBI-005

• Placebo Comparator

Locations

Country	Name	City	State
United States	Investigational Site	Artesia	California
United States	Investigational Site	Bangor	Maine
United States	Investigational Site	Bloomingdale	Illinois
United States	Investigational Site	Boston	Massachusetts
United States	Investigational Site	Chandler	Arizona
United States	Investigational Site	Chesterfield	Missouri
United States	Investigational Site	Cleveland	Ohio
United States	Investigational Site	Cranberry Township	Pennsylvania
United States	Investigational Site	Des Peres	Missouri
United States	Investigational Site	Hamden	Connecticut
United States	Investigational Site	High Point	North Carolina
United States	Investigational Site	Houston	Texas
United States	Investigational Site#2	Houston	Texas
United States	Investigational Site	Indianapolis	Indiana
United States	Investigational Site	Indianapolis	Indiana
United States	Investigational Site	Kansas City	Missouri
United States	Investigational Site	Lancaster	Pennsylvania
United States	Investigational Site	Las Vegas	Nevada
United States	Investigational Site	League City	Texas
United States	Investigational Site	Lexington	Kentucky
United States	Investigational Site	Little Rock	Arkansas
United States	Investigational Site	Littleton	Colorado
United States	Investigational Site	Louisville	Kentucky
United States	Investigational Site	Louisville	Kentucky
United States	Investigational Site	Memphis	Tennessee
United States	Investigational Site	Mesa	Arizona
United States	Investigational Site	Mission Hills	California
United States	Investigational Site	New Albany	Indiana
United States	Investigational Site	New York	New York
United States	Investigational Site	Norfolk	Virginia
United States	Investigational Site	Petaluma	California
United States	Investigational Site	Pittsburgh	Pennsylvania
United States	Investigational Site	Plantation	Florida
United States	Investigational Site	Rancho Cordova	California
United States	Investigational Site	Rapid City	South Dakota
United States	Investigational Site	Rochester	New York
United States	Investigational Site	Roswell	Georgia
United States	Investigational Site	San Antonio	Texas
United States	Investigational Site# 2	San Antonio	Texas
United States	Investiational Site	San Diego	California
United States	Investigational Site	St. Louis	Missouri
United States	Investigational Site	Torrence	California
United States	Investigational Site	Wantagh	New York
United States	Investigational Site	Washington	Missouri
United States	Investigational Site	Winchester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Eleven Biotherapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NEI score for Total Corneal Fluorescein Staining (TCFS)	To evaluate the efficacy of EBI-005 5 mg/mL topical ophthalmic solution given three times daily for 12 weeks as measured by the change in the NEI score for the Total Corneal Fluorescein Staining [sign] from baseline to Week 12 and a change in ocular pain as measured by the painful or sore eye question on the OSDI [symptom] of DED from baseline to Week 12 as compared to vehicle control.	3 months	Yes
Secondary	The key secondary endpoint is total OSDI score	Change from baseline to week 12 in Total OSDI score.	3 months	No