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

Allergic Conjunctivitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02082899
• Other study ID #: EBI-005-AC-1
• 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

Related Conditions & MeSH terms

• Allergic Conjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

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