A Single Center Study for the Treatment of Moderate to Severe Allergic Conjunctivitis (EBI-005-AC-1)
NCT02082899 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2014-07-11
Summary
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.
Conditions
- Allergic Conjunctivitis
Interventions
- DRUG
-
Active Comparator EBI-005 5 mg/mL
- DRUG
-
Placebo Comparator
Sponsors & Collaborators
-
Eleven Biotherapeutics
lead INDUSTRY
Principal Investigators
-
Michael Goldstein, MD · Eleven Biotherapeutics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-02-28
- Primary Completion
- 2014-06-30
- Completion
- 2014-07-31
Countries
- Canada
Study Locations
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