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

• ClinicalTrials.gov Identifier: NCT02492321
• Recruitment Status: Completed
• First Posted: July 8, 2015
• Last Update Posted: February 11, 2016
• Sponsor: Eleven Biotherapeutics
• Information provided by (Responsible Party): Eleven Biotherapeutics

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.

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

• Study Director: Michael Goldstein, MD; Eleven Biotherapeutics

More Information

• Responsible Party: Eleven Biotherapeutics
• ClinicalTrials.gov Identifier: NCT02492321
• Other Study ID Numbers: EBI-005-AC-2
• First Posted: July 8, 2015
• Last Update Posted: February 11, 2016
• Last Verified: February 2016

Additional relevant MeSH terms:

Conjunctivitis; Conjunctivitis, Allergic; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases