search
Back to results

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

Primary Purpose

Allergic Conjunctivitis (AC)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
EBI-005
Placebo Comparator
Sponsored by
Eleven Biotherapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Conjunctivitis (AC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site
  • Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

EBI-005

Vehicle

Arm Description

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

Placebo Comparator: One of two study arms: placebo topical administered 3 times per day

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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

Full Information

First Posted
July 2, 2015
Last Updated
February 10, 2016
Sponsor
Eleven Biotherapeutics
search

1. Study Identification

Unique Protocol Identification Number
NCT02492321
Brief Title
A Multi-Center Environmental Study for the Treatment of Moderate to Severe Ocular Allergic Conjunctivitis
Acronym
EBI-005-AC-2
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
December 2015 (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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Conjunctivitis (AC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EBI-005
Arm Type
Active Comparator
Arm Description
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
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Placebo Comparator: One of two study arms: placebo topical administered 3 times per day
Intervention Type
Drug
Intervention Name(s)
EBI-005
Intervention Type
Drug
Intervention Name(s)
Placebo Comparator
Primary Outcome Measure Information:
Title
Morning ocular itching diary scores
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Late afternoon ocular itching diary scores
Description
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
Time Frame
14 days
Title
Evening ocular itching diary scores
Description
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
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Goldstein, MD
Organizational Affiliation
Eleven Biotherapeutics
Official's Role
Study Director
Facility Information:
City
Morrow
State/Province
Georgia
ZIP/Postal Code
30260
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
Investigational Site
City
Quincy
State/Province
Massachusetts
ZIP/Postal Code
02169
Country
United States
Facility Name
Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45238
Country
United States
Facility Name
Investigational Site
City
Mason
State/Province
Ohio
ZIP/Postal Code
45040
Country
United States
Facility Name
Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Multi-Center Environmental Study for the Treatment of Moderate to Severe Ocular Allergic Conjunctivitis

We'll reach out to this number within 24 hrs