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Completed

NCT Number: NCT02082899

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigation Site

Mississauga, Ontario, L4W 1A2, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Comparator EBI-005 5 mg/mL

Drug

placebo comparator

Drug

Primary outcomes

  1. Ocular itching in EEC arm at a specific visit comparing EBI-005 vs vehicle

    Time frame: 17 days

Secondary outcomes

  1. Evaluation of Adverse Events.

    Time frame: up to 45 days

    Frequency, severity and relationship to study medication of all Adverse Events occurring during the study.

  2. Evaluation of antibodies to EBI-005.

    Time frame: up to 45 days

    Number and percent of subjects who develop drug antibodies over time

  3. Evaluation of ocular changes

    Time frame: up to 45 days

    Changes in ophthalmic examinations over time.

Sponsors and collaborators

Lead sponsor

Eleven Biotherapeutics

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 10, 2014
Registry last updated
Jul 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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