A Multi-Center Environmental Study for the Treatment of Moderate to Severe Ocular Allergic Conjunctivitis (EBI-005-AC-2)

A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled Evaluation of the Efficacy, Safety, and Tolerability of EBI-005 in Subjects With Moderate to Severe Ocular Allergic Conjunctivitis

This is a Phase III multi-center, double-masked, vehicle-controlled, randomized, parallel group study evaluating the efficacy, safety and tolerability of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe allergic conjunctivitis (AC) three times daily for 4 weeks.

Approximately 250 subjects at approximately 8 centers in the US will be screened and enrolled into the study.

Study Overview

• Status: Completed
• Conditions: Allergic Conjunctivitis (AC)
• Intervention / Treatment: Drug: Placebo Comparator; Drug: EBI-005

• Study Type: Interventional
• Enrollment (Actual): 250
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Morrow, Georgia, United States, 30260
  • Kentucky
    • Louisville, Kentucky, United States, 40206
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
    • Quincy, Massachusetts, United States, 02169
      • Investigational Site
  • Missouri
    • St. Louis, Missouri, United States, 63131
      • Investigational Site
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
  • Ohio
    • Cincinnati, Ohio, United States, 45238
      • Investigational Site
    • Mason, Ohio, United States, 45040
      • Investigational Site
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19134
      • Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
  • Texas
    • San Antonio, Texas, United States, 78209

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Give written informed consent and any authorization required by local law (e.g., Protected Health Information waiver) prior to performing any study procedures;
• Are ≥18 years of age;
• Have a positive history of ocular allergies during ragweed pollen season;
• Have signs and symptoms of allergic conjunctivitis in both eyes;
• If female and of child-bearing potential, she must not be pregnant or lactating

Exclusion Criteria:

• Have signs of ocular infection;
• Have a known history of alcohol or drug abuse;
• Have been exposed to an investigational drug or device within 30 days of the study;
• Have planned surgery (ocular or systemic) during the trial period or within 30 days after

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: EBI-005; Drug: EBI-005 The investigational drug EBI-005, is an intervention to one of two study arms: 5 mg/mL topical administered 3 times per day	Drug: EBI-005
Placebo Comparator: Vehicle; Placebo Comparator: One of two study arms: placebo topical administered 3 times per day	Drug: Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morning ocular itching diary scores	To evaluate the efficacy of EBI-005 as compared to vehicle-control in the treatment of ocular itching associated with allergic conjunctivitis during ragweed pollen season.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Late afternoon ocular itching diary scores	The key secondary endpoints are to evaluate the efficacy of EBI-005 as compared to vehicle-control in the treatment of ocular itching associated with allergic conjunctivitis during ragweed pollen season	14 days
Evening ocular itching diary scores	The key secondary endpoints are to evaluate the efficacy of EBI-005 as compared to vehicle-control in the treatment of ocular itching associated with allergic conjunctivitis during ragweed pollen season	14 days

Collaborators and Investigators

• Sponsor: Eleven Biotherapeutics

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: July 2, 2015
• First Submitted That Met QC Criteria: July 6, 2015
• First Posted (Estimate): July 8, 2015

Study Record Updates

• Last Update Posted (Estimate): February 11, 2016
• Last Update Submitted That Met QC Criteria: February 10, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity, Immediate; Eye Diseases; Hypersensitivity; Conjunctival Diseases; Conjunctivitis; Conjunctivitis, Allergic
• Other Study ID Numbers: EBI-005-AC-2