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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
670
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.
Time frame: 3 months
The key secondary endpoint is total OSDI score
Change from baseline to week 12 in Total OSDI score.
Time frame: 3 months
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Investigational Site
Chandler, Arizona, United States
Investigational Site
Mesa, Arizona, United States
Investigational Site
Little Rock, Arkansas, United States
Investigational Site
Artesia, California, United States
Investigational Site
Mission Hills, California, United States
Investigational Site
Petaluma, California, United States
Investigational Site
Rancho Cordova, California, United States
Investiational Site
San Diego, California, United States
Investigational Site
Torrence, California, United States
Investigational Site
Littleton, Colorado, United States
...and 35 more locations