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

Allergic Conjunctivitis (AC) Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02492321
• Other study ID #: EBI-005-AC-2
• Status: Completed
• Phase: Phase 3
• First received: July 2, 2015
• Last updated: February 10, 2016
• Start date: July 2015
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Eleven Biotherapeutics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Conjunctivitis (AC)
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

Drug:
• EBI-005

• Placebo Comparator

Locations

Country	Name	City	State
United States	Investigational Site	Cincinnati	Ohio
United States	Investigational Site	Mason	Ohio
United States	Investigational Site	Philadelphia	Pennsylvania
United States	Investigational Site	Quincy	Massachusetts
United States	Investigational Site	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Eleven Biotherapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	14 days	No
Secondary	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	14 days	No