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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02492321
Recruitment Status : Completed
First Posted : July 8, 2015
Last Update Posted : February 11, 2016
Sponsor:
Information provided by (Responsible Party):
Eleven Biotherapeutics

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.


Condition or disease Intervention/treatment Phase
Allergic Conjunctivitis (AC) Drug: EBI-005 Drug: Placebo Comparator Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pink Eye

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



Primary Outcome Measures :
  1. Morning ocular itching diary scores [ Time Frame: 14 days ]
    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 :
  1. Late afternoon ocular itching diary scores [ Time Frame: 14 days ]
    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

  2. Evening ocular itching diary scores [ Time Frame: 14 days ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02492321


Locations
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United States, Georgia
Morrow, Georgia, United States, 30260
United States, Kentucky
Louisville, Kentucky, United States, 40206
United States, Massachusetts
Andover, Massachusetts, United States, 01810
Investigational Site
Quincy, Massachusetts, United States, 02169
United States, Missouri
Investigational Site
St. Louis, Missouri, United States, 63131
United States, North Carolina
Charlotte, North Carolina, United States, 28204
United States, Ohio
Investigational Site
Cincinnati, Ohio, United States, 45238
Investigational Site
Mason, Ohio, United States, 45040
United States, Pennsylvania
Investigational Site
Philadelphia, Pennsylvania, United States, 19134
United States, Tennessee
Memphis, Tennessee, United States, 38119
United States, Texas
San Antonio, Texas, United States, 78209
Sponsors and Collaborators
Eleven Biotherapeutics
Investigators
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Study Director: Michael Goldstein, MD Eleven Biotherapeutics
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Responsible Party: Eleven Biotherapeutics
ClinicalTrials.gov Identifier: NCT02492321    
Other Study ID Numbers: EBI-005-AC-2
First Posted: July 8, 2015    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016
Additional relevant MeSH terms:
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Conjunctivitis
Conjunctivitis, Allergic
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases