Clinical trial NCT02082899: A Single Center Study for the Treatment of Moderate to Severe Allergic Conjunctivitis (EBI-005-AC-1)
Official title: A 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Conjunctivitis
Keywords: Allergic Conjunctivitis
Interleukin 1 Receptor Inhibitor
Environmental Exposure Chamber
Conjunctival Allergen Provocation Test
Lead sponsor: Eleven Biotherapeutics
Sponsor class: INDUSTRY
First posted: 2014-03-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Provide written informed consent prior to any study-related procedures.
* Be 18 years of age or older.
* Have at least a 2 year history of moderate to severe allergic conjunctivitis.
* Have a positive skin prick test to ragweed within the past 12 months of Screening (Visit 1A).
* Have a score of ≥ 2 for staff-assessed ocular redness in at least one region (nasal or temporal) in each eye and ≥ 2 for subject-assessed ocular itching within the 3.5-hour period of allergen exposure in the EEC at Visit 1B.
* Have required more than one anti-allergy pharmaceutical treatments in the past 2 years to treat ocular symptoms (including oral, topical, nasal treatments).
* Be able to self-administer topical ophthalmic drops.
* Avoid any topical or systemic ocular medications during the entire study period.
* Are willing and able to follow instructions and can be present for the required study visits for the duration of the study.

Exclusion Criteria:

* Are female and of childbearing potential and unwilling to remain abstinent through 30 days following the last dose of study drug or not willing to use acceptable birth control methods.
* Have previously used an IL-1 blocker (e.g., Anakinra, Rilonacept, or Ilaris).
* Have a known contraindication or hypersensitivities to Anakinra (Kineret®) or any therapeutic agent targeted to IL-1 or any component of study drug formulation.
* Current participation in another clinical study involving an experimental treatment or participation in such a study within 30 days prior to study entry.
* Require concomitant use of TNF-blocking agents (e.g., Etanercept, Adalimumab, Infliximab).
* Have a history of glaucoma or intraocular pressure (IOP) \> 25 mmHg at the Visit 1A (Medical Screening) or a history of elevated IOP within the past year.
* Have had ocular surgery including laser procedures within the past 12 months of Visit 1A (Medical Screening).
* Have had contact lens wear within 4 weeks prior to Visit 1A (Medical Screening) or unwilling to discontinue wear during the study period

Primary outcomes:
measure: Ocular itching in EEC arm at a specific visit comparing EBI-005 vs vehicle
timeFrame: 17 days
Secondary outcomes:
measure: Evaluation of Adverse Events.
timeFrame: up to 45 days
measure: Evaluation of antibodies to EBI-005.
timeFrame: up to 45 days
measure: Evaluation of ocular changes
timeFrame: up to 45 days
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Investigation Site
state: Ontario
Study officials:
affiliation: Eleven Biotherapeutics
name: Michael Goldstein, MD
role: STUDY_DIRECTOR
References: