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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eleven Biotherapeutics
ClinicalTrials.gov Identifier:
NCT02082899
First received: March 4, 2014
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Allergic Conjunctivitis
Drug: Active Comparator EBI-005 5 mg/mL
Drug: Placebo Comparator
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Eleven Biotherapeutics:

Primary Outcome Measures:
  • Ocular itching in EEC arm at a specific visit comparing EBI-005 vs vehicle [ Time Frame: 17 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of Adverse Events. [ Time Frame: up to 45 days ] [ Designated as safety issue: Yes ]
    Frequency, severity and relationship to study medication of all Adverse Events occurring during the study.

  • Evaluation of antibodies to EBI-005. [ Time Frame: up to 45 days ] [ Designated as safety issue: Yes ]
    Number and percent of subjects who develop drug antibodies over time

  • Evaluation of ocular changes [ Time Frame: up to 45 days ] [ Designated as safety issue: No ]
    Changes in ophthalmic examinations over time.


Enrollment: 150
Study Start Date: February 2014
Study Completion Date: July 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Active Comparator EBI-005 5 mg/mL
Administered 3 times per day
Drug: Active Comparator EBI-005 5 mg/mL
Placebo Comparator: Placebo Comparator
Administered 3 times per day
Drug: Placebo Comparator

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02082899

Locations
Canada, Ontario
Investigation Site
Mississauga, Ontario, Canada, L4W 1A2
Sponsors and Collaborators
Eleven Biotherapeutics
Investigators
Study Director: Michael Goldstein, MD Eleven Biotherapeutics
  More Information

No publications provided

Responsible Party: Eleven Biotherapeutics
ClinicalTrials.gov Identifier: NCT02082899     History of Changes
Other Study ID Numbers: EBI-005-AC-1
Study First Received: March 4, 2014
Last Updated: July 10, 2014
Health Authority: Canada: Health Canada

Keywords provided by Eleven Biotherapeutics:
Allergic Conjunctivitis
Interleukin 1 Receptor Inhibitor
Environmental Exposure Chamber
Conjunctival Allergen Provocation Test

Additional relevant MeSH terms:
Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014