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
1 other identifier
interventional
250
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2015
Shorter than P25 for phase_3
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2015
CompletedFirst Submitted
Initial submission to the registry
July 2, 2015
CompletedFirst Posted
Study publicly available on registry
July 8, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 11, 2016
February 1, 2016
4 months
July 2, 2015
February 10, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Late afternoon ocular itching diary scores
14 days
Evening ocular itching diary scores
14 days
Study Arms (2)
EBI-005
ACTIVE COMPARATORDrug: 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
Vehicle
PLACEBO COMPARATORPlacebo Comparator: One of two study arms: placebo topical administered 3 times per day
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Unknown Facility
Morrow, Georgia, 30260, United States
Unknown Facility
Louisville, Kentucky, 40206, United States
Unknown Facility
Andover, Massachusetts, 01810, United States
Investigational Site
Quincy, Massachusetts, 02169, United States
Investigational Site
St Louis, Missouri, 63131, United States
Unknown Facility
Charlotte, North Carolina, 28204, United States
Investigational Site
Cincinnati, Ohio, 45238, United States
Investigational Site
Mason, Ohio, 45040, United States
Investigational Site
Philadelphia, Pennsylvania, 19134, United States
Unknown Facility
Memphis, Tennessee, 38119, United States
Unknown Facility
San Antonio, Texas, 78209, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Michael Goldstein, MD
Eleven Biotherapeutics
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2015
First Posted
July 8, 2015
Study Start
July 1, 2015
Primary Completion
November 1, 2015
Study Completion
December 1, 2015
Last Updated
February 11, 2016
Record last verified: 2016-02