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CompletedNCT02082899Updated Jul 11, 2014

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

A Phase 2 interventional study of Active Comparator EBI-005 5 mg/mL and Placebo Comparator in Allergic Conjunctivitis, sponsored by Eleven Biotherapeutics. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-11.

Sponsored by Eleven Biotherapeutics · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Allergic Conjunctivitis

Keywords

  • Allergic Conjunctivitis
  • Interleukin 1 Receptor Inhibitor
  • Environmental Exposure Chamber
  • Conjunctival Allergen Provocation Test
03

In context

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

This study's enrollment of 150 is above the median of 100 across 299 interventional studies indexed under Conjunctivitis.

Browse Conjunctivitis studies →

Lead sponsor

Eleven Biotherapeutics is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
150 participants (actual)

Study arms

  • 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

Interventions

  • DrugActive Comparator EBI-005 5 mg/mL
  • DrugPlacebo Comparator
06

What researchers measure

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.

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

    Time frame: up to 45 days

  2. Evaluation of antibodies to EBI-005.

    Number and percent of subjects who develop drug antibodies over time

    Time frame: up to 45 days

  3. Evaluation of ocular changes

    Changes in ophthalmic examinations over time.

    Time frame: up to 45 days

07

Study locations

1 site
  • Investigation Site
    Mississauga, Ontario L4W 1A2, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 11, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02082899
Lead sponsor
Eleven Biotherapeutics
Responsible party
Sponsor
First posted
Mar 10, 2014
Start date
Feb 2014
Primary completion
Jun 2014
Completion
Jul 2014
Last update
Jul 11, 2014

Study contacts

Michael Goldstein, MD
study director · Eleven Biotherapeutics

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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