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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02082899
Other study ID # EBI-005-AC-1
Secondary ID
Status Completed
Phase Phase 2
First received March 4, 2014
Last updated July 10, 2014
Start date February 2014
Est. completion date July 2014

Study information

Verified date July 2014
Source Eleven Biotherapeutics
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date July 2014
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment


Intervention

Drug:
Active Comparator EBI-005 5 mg/mL

Placebo Comparator


Locations

Country Name City State
Canada Investigation Site Mississauga Ontario

Sponsors (1)

Lead Sponsor Collaborator
Eleven Biotherapeutics

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Ocular itching in EEC arm at a specific visit comparing EBI-005 vs vehicle 17 days No
Secondary Evaluation of Adverse Events. Frequency, severity and relationship to study medication of all Adverse Events occurring during the study. up to 45 days Yes
Secondary Evaluation of antibodies to EBI-005. Number and percent of subjects who develop drug antibodies over time up to 45 days Yes
Secondary Evaluation of ocular changes Changes in ophthalmic examinations over time. up to 45 days No
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