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

Status:	Completed
Conditions:	Ocular
Therapuetic Areas:	Ophthalmology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	July 2015
End Date:	December 2015

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

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.

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

We found this trial at

sites

Clinical Trial Facility in Mason Ohio

Mason, Ohio 45040

737

from

Mason, OH