Clinical trial NCT01998802: Phase 3 Study of EBI-005 in Dry Eye Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease (DED)
Lead sponsor: Eleven Biotherapeutics
Sponsor class: INDUSTRY
First posted: 2013-12-02
Enrollment: 670
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: NEI score for Total Corneal Fluorescein Staining (TCFS)
timeFrame: 3 months
Secondary outcomes:
measure: The key secondary endpoint is total OSDI score
timeFrame: 3 months
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Investigational Site
state: Arizona
city: Mesa
country: United States
facility: Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Investigational Site
state: Arkansas
city: Artesia
country: United States
facility: Investigational Site
state: California
city: Mission Hills
country: United States
facility: Investigational Site
state: California
city: Petaluma
country: United States
facility: Investigational Site
state: California
city: Rancho Cordova
country: United States
facility: Investigational Site
state: California
city: San Diego
country: United States
facility: Investiational Site
state: California
city: Torrence
country: United States
facility: Investigational Site
state: California
city: Littleton
country: United States
facility: Investigational Site
state: Colorado
city: Hamden
country: United States
facility: Investigational Site
state: Connecticut
city: Plantation
country: United States
facility: Investigational Site
state: Florida
city: Roswell
country: United States
facility: Investigational Site
state: Georgia
city: Bloomingdale
country: United States
facility: Investigational Site
state: Illinois
city: Indianapolis
country: United States
facility: Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: Investigational Site
state: Indiana
city: New Albany
country: United States
facility: Investigational Site
state: Indiana
city: Lexington
country: United States
facility: Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Investigational Site
state: Kentucky
city: Louisville
country: United States
facility: Investigational Site
state: Kentucky
city: Bangor
country: United States
facility: Investigational Site
state: Maine
city: Boston
country: United States
facility: Investigational Site
state: Massachusetts
city: Winchester
country: United States
facility: Investigational Site
state: Massachusetts
city: Chesterfield
country: United States
facility: Investigational Site
state: Missouri
city: Des Peres
country: United States
facility: Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: Investigational Site
state: Missouri
city: St. Louis
country: United States
facility: Investigational Site
state: Missouri
city: Washington
country: United States
facility: Investigational Site
state: Missouri
city: Las Vegas
country: United States
facility: Investigational Site
state: Nevada
city: New York
country: United States
facility: Investigational Site
state: New York
city: Rochester
country: United States
facility: Investigational Site
state: New York
city: Wantagh
country: United States
facility: Investigational Site
state: New York
city: High Point
country: United States
facility: Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Investigational Site
state: Ohio
city: Cranberry Township
country: United States
facility: Investigational Site
state: Pennsylvania
city: Lancaster
country: United States
facility: Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Investigational Site
state: Pennsylvania
city: Rapid City
country: United States
facility: Investigational Site
state: South Dakota
city: Memphis
country: United States
facility: Investigational Site
state: Tennessee
city: Houston
country: United States
facility: Investigational Site
state: Texas
city: Houston
country: United States
facility: Investigational Site#2
state: Texas
city: League City
country: United States
facility: Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Investigational Site# 2
state: Texas
city: Norfolk
country: United States
facility: Investigational Site
state: Virginia
Study officials:
References: