This is a Phase 1b, multi-center, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the safety and biological activity of two doses of EBI-005 ophthalmic solution versus placebo in subjects with moderate to severe Dry Eye Syndrome. Approximately 72 subjects will be enrolled and randomized in this study at up to 9 centers located in the United States (US). Subjects will be enrolled in two groups or cohorts. The first enrollment group will consist of 33 subjects.
* To investigate the safety and tolerability of EBI-005 ophthalmic solution compared to placebo in the treatment of patients with moderate to severe Dry Eye Syndrome (DES). * To evaluate pharmacokinetic (PK) parameters and immunogenicity of two different doses of EBI-005 ophthalmic solution. * To investigate the biological activity of multiple doses of EBI-005 ophthalmic solution compared to placebo as assessed by both objective and subjective assessments. * To investigate the comparative dose response of two different doses of EBI-005 ophthalmic solution. * To investigate the comparative tolerability of two different doses of EBI-005 ophthalmic solution. * To identify key biomarkers in the diagnosis and management of subjects with DES.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
74
The investigational drug EBI-005-2, is an intervention to three different study arms. One arm gets 5mg/ml, the other gets 20mg/ml and the last arm is Placebo.
Investigational Site
Artesia, California, United States
Investigational Site
Ranchero Cordova, California, United States
Investigational Site
Torrence, California, United States
Investigational Site
Kansas City, Missouri, United States
OSDI (Ocular Surface Disease Index)
OSDI is a subject assessment tool to determine subject Dry Eye Syndrome symptoms
Time frame: 2 months
Change from baseline in total corneal fluorescein staining
Corneal staining assessment will be performed using methods developed by the NEI Dry Eye Workshop.
Time frame: 2 months
Symptom Assessment in Dry Eye (Modified SANDE)
Patient Reported Outcome using a Visual Analog Scale for Modified SANDE.
Time frame: 2 months
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Investigational Site
Washington, Missouri, United States
Investigational Site
Cleveland, Ohio, United States
Investigational Site
San Antonio, Texas, United States
Investigational Site
Norfolk, Virginia, United States