Dry Eye Disease (DED) Clinical Trial
— EBI-005Official 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
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Eleven Biotherapeutics |
United States,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04140227 -
Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)
|
Phase 3 | |
Completed |
NCT04393441 -
Efficacy and Safety of a New Artificial Tear Formulation Compared With Systane Ultra Multidose in Participants With Dry Eye Disease
|
Phase 3 | |
Completed |
NCT04036292 -
Evaluation of the Efficacy and Safety of OC-01 Nasal Spray on Signs and Symptoms of Dry Eye Disease
|
Phase 3 | |
Completed |
NCT04139798 -
Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)
|
Phase 3 | |
Completed |
NCT04523142 -
CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004
|
Phase 3 | |
Completed |
NCT03333057 -
Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
|
Phase 2 | |
Completed |
NCT05723770 -
Effects of NOV03 on the Tear Film
|
Phase 4 |