Phase 3 Study of EBI-005 in Dry Eye Disease
EBI-005
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
1 other identifier
interventional
670
1 country
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2014
Shorter than P25 for phase_3
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 25, 2013
CompletedFirst Posted
Study publicly available on registry
December 2, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedJune 11, 2015
June 1, 2015
1.2 years
November 25, 2013
June 10, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
The key secondary endpoint is total OSDI score
3 months
Study Arms (2)
Active Comparator: EBI-005
ACTIVE COMPARATORDrug: EBI-005 The investigational drug EBI-005, is an intervention to one of two study arms: 5 mg/mL topical administered 3 times per day.
Placebo Comparator
PLACEBO COMPARATOROne of two study arms: placebo topical administered 3 times per day.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Investigational Site
Chandler, Arizona, 85225, United States
Investigational Site
Mesa, Arizona, 85208, United States
Investigational Site
Little Rock, Arkansas, 72212, United States
Investigational Site
Artesia, California, 90701, United States
Investigational Site
Mission Hills, California, 91345, United States
Investigational Site
Petaluma, California, 94954, United States
Investigational Site
Rancho Cordova, California, 95670, United States
Investiational Site
San Diego, California, 92115, United States
Investigational Site
Torrence, California, 90505, United States
Investigational Site
Littleton, Colorado, 80120, United States
Investigational Site
Hamden, Connecticut, 06518, United States
Investigational Site
Plantation, Florida, 33324, United States
Investigational Site
Roswell, Georgia, 30076, United States
Investigational Site
Bloomingdale, Illinois, 60108, United States
Investigational Site
Indianapolis, Indiana, 46260, United States
Investigational Site
Indianapolis, Indiana, 46290, United States
Investigational Site
New Albany, Indiana, 47150, United States
Investigational Site
Lexington, Kentucky, 40509, United States
Investigational Site
Louisville, Kentucky, 40206, United States
Investigational Site
Louisville, Kentucky, 40217, United States
Investigational Site
Bangor, Maine, 04401, United States
Investigational Site
Boston, Massachusetts, 02114, United States
Investigational Site
Winchester, Massachusetts, 01890, United States
Investigational Site
Chesterfield, Missouri, 63017, United States
Investigational Site
Des Peres, Missouri, 63131, United States
Investigational Site
Kansas City, Missouri, 64111, United States
Investigational Site
St Louis, Missouri, 63131, United States
Investigational Site
Washington, Missouri, 63090, United States
Investigational Site
Las Vegas, Nevada, 89148, United States
Investigational Site
New York, New York, 10036, United States
Investigational Site
Rochester, New York, 14618, United States
Investigational Site
Wantagh, New York, 11793, United States
Investigational Site
High Point, North Carolina, 27262, United States
Investigational Site
Cleveland, Ohio, 44115, United States
Investigational Site
Cranberry Township, Pennsylvania, 16066, United States
Investigational Site
Lancaster, Pennsylvania, 17601, United States
Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
Investigational Site
Rapid City, South Dakota, 57701, United States
Investigational Site
Memphis, Tennessee, 38119, United States
Investigational Site
Houston, Texas, 77034, United States
Investigational Site#2
Houston, Texas, 77055, United States
Investigational Site
League City, Texas, 77573, United States
Investigational Site
San Antonio, Texas, 78209, United States
Investigational Site# 2
San Antonio, Texas, 78229, United States
Investigational Site
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 25, 2013
First Posted
December 2, 2013
Study Start
January 1, 2014
Primary Completion
March 1, 2015
Study Completion
April 1, 2015
Last Updated
June 11, 2015
Record last verified: 2015-06