A Single Center Study for the Treatment of Moderate to Severe Allergic Conjunctivitis (EBI-005-AC-1)

NCT ID: NCT02082899

Last Updated: 2014-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2014-07-31

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.

Conditions

Allergic Conjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Active Comparator EBI-005 5 mg/mL

Administered 3 times per day

Group Type: ACTIVE_COMPARATOR

Active Comparator EBI-005 5 mg/mL

Intervention Type: DRUG

Placebo Comparator

Administered 3 times per day

Group Type: PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type: DRUG

Interventions

Active Comparator EBI-005 5 mg/mL

Intervention Type: DRUG

Placebo Comparator

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eleven Biotherapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Goldstein, MD

Role: STUDY_DIRECTOR

Eleven Biotherapeutics

Locations

Investigation Site

Mississauga, Ontario, Canada

Countries

Canada

Other Identifiers

EBI-005-AC-1

Identifier Type: -

Identifier Source: org_study_id