This is a Phase II Single Center, Randomized, Double-Masked, Vehicle-Controlled, Parallel, Group Study to Assess the Efficacy of EBI-005 Topical Ophthalmic Solution for the Treatment of Moderate to Severe Allergic Conjunctivitis Using an Environmental Exposure Chamber (EEC) Model and Conjunctival Allergen Provocation Test (CAPT) Model. Approximately 150 subjects will be enrolled and randomized in one study center in Canada for a duration of 0.33 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
150
Investigation Site
Mississauga, Ontario, Canada
Ocular itching in EEC arm at a specific visit comparing EBI-005 vs vehicle
Time frame: 17 days
Evaluation of Adverse Events.
Frequency, severity and relationship to study medication of all Adverse Events occurring during the study.
Time frame: up to 45 days
Evaluation of antibodies to EBI-005.
Number and percent of subjects who develop drug antibodies over time
Time frame: up to 45 days
Evaluation of ocular changes
Changes in ophthalmic examinations over time.
Time frame: up to 45 days
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