A Phase 2 interventional study of Active Comparator EBI-005 5 mg/mL and Placebo Comparator in Allergic Conjunctivitis, sponsored by Eleven Biotherapeutics. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-11.
Sponsored by Eleven Biotherapeutics · Phase 2, Interventional, and Treatment
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.
361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.
This study's enrollment of 150 is above the median of 100 across 299 interventional studies indexed under Conjunctivitis.
Browse Conjunctivitis studies →Eleven Biotherapeutics is the lead sponsor of 7 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Administered 3 times per day
Drug: Active Comparator EBI-005 5 mg/mL
Administered 3 times per day
Drug: Placebo Comparator
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
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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Eleven Biotherapeutics