Back to resultsA Single Center Study for the Treatment of Moderate to Severe Allergic Conjunctivitis (EBI-005-AC-1)
Primary Purpose
Allergic Conjunctivitis
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Active Comparator EBI-005 5 mg/mL
Placebo Comparator
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Conjunctivitis focused on measuring Allergic Conjunctivitis, Interleukin 1 Receptor Inhibitor, Environmental Exposure Chamber, Conjunctival Allergen Provocation Test
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
Sites / Locations
- Investigation Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Active Comparator EBI-005 5 mg/mL
Placebo Comparator
Arm Description
Administered 3 times per day
Administered 3 times per day
Outcomes
Primary Outcome Measures
Ocular itching in EEC arm at a specific visit comparing EBI-005 vs vehicle
Secondary Outcome Measures
Evaluation of Adverse Events.
Frequency, severity and relationship to study medication of all Adverse Events occurring during the study.
Evaluation of antibodies to EBI-005.
Number and percent of subjects who develop drug antibodies over time
Evaluation of ocular changes
Changes in ophthalmic examinations over time.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02082899
Brief Title
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
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eleven Biotherapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis
Keywords
Allergic Conjunctivitis, Interleukin 1 Receptor Inhibitor, Environmental Exposure Chamber, Conjunctival Allergen Provocation Test
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Comparator EBI-005 5 mg/mL
Arm Type
Active Comparator
Arm Description
Administered 3 times per day
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Administered 3 times per day
Intervention Type
Drug
Intervention Name(s)
Active Comparator EBI-005 5 mg/mL
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Primary Outcome Measure Information:
Title
Ocular itching in EEC arm at a specific visit comparing EBI-005 vs vehicle
Time Frame
17 days
Secondary Outcome Measure Information:
Title
Evaluation of Adverse Events.
Description
Frequency, severity and relationship to study medication of all Adverse Events occurring during the study.
Time Frame
up to 45 days
Title
Evaluation of antibodies to EBI-005.
Description
Number and percent of subjects who develop drug antibodies over time
Time Frame
up to 45 days
Title
Evaluation of ocular changes
Description
Changes in ophthalmic examinations over time.
Time Frame
up to 45 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Goldstein, MD
Organizational Affiliation
Eleven Biotherapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Investigation Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1A2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
A Single Center Study for the Treatment of Moderate to Severe Allergic Conjunctivitis (EBI-005-AC-1)
We'll reach out to this number within 24 hrs