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
Sponsor study identifier
interventional
250
1 country
11
Study Start
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2015
Actual (reported)Study Completion
December 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
July 2, 2015
Actual (reported)July 8, 2015
Actual (reported)November 2015
Actual (reported)December 2015
Actual (reported)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
Late afternoon ocular itching diary scores
14 days
Evening ocular itching diary scores
14 days
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Morrow, Georgia, 30260, United States
Louisville, Kentucky, 40206, United States
Andover, Massachusetts, 01810, United States
Investigational Site
Quincy, Massachusetts, 02169, United States
Investigational Site
St Louis, Missouri, 63131, United States
Charlotte, North Carolina, 28204, United States
Investigational Site
Cincinnati, Ohio, 45238, United States
Michael Goldstein, MD
Eleven Biotherapeutics
250 participants (actual enrollment reported by the registry).
First Submitted
July 2, 2015
First Posted
July 8, 2015
Study Start
July 2015
Date type not reportedThis date has not been verified as actual or estimated.
A Single-Center,Evaluation of the Onset and Duration of Action of AC-170 0.24% Compared to Vehicle
Contact the study team to confirm eligibility.
Investigational Site
Mason, Ohio, 45040, United States
Investigational Site
Philadelphia, Pennsylvania, 19134, United States
Memphis, Tennessee, 38119, United States
San Antonio, Texas, 78209, United States
Primary Completion
November 2015
Actual (reported)Study Completion
December 2015
Actual (reported)Last Updated
February 11, 2016
Record last verified: 2016-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: