Study of EBI-005 in Dry Eye Disease (DED)

Status:	Recruiting
Conditions:	Ocular, Ocular
Therapuetic Areas:	Ophthalmology
Healthy:	No
Age Range:	18 - Any
Updated:	7/11/2015
Start Date:	April 2015
End Date:	July 2016
Contact:	Eleven Biotherapeutics
Email:	info@elevenbio.com

A Multi-Center, Double-Masked, Randomized, One-Year Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle-Control in Subjects With Dry Eye Disease (DED)

This is a randomized, double masked study designed to evaluate the safety of EBI-005 5 mg/mL
topical ophthalmic solution given three times daily (TID) compared to vehicle-control over a
one year period in subjects with dry eye disease (DED). Approximately 188 subjects will be
enrolled to either EBI-005 or vehicle at up to 15 centers in the United States (US) and
Canada.

Key Inclusion Criteria:

1. Have a history of dry eye disease (DED) in both eyes supported by a previous clinical
diagnosis or have a self-reported history of subjective complaints for at least 6
months prior to Visit 1

2. Are willing and able to follow instructions and can be present for the required study
visits for the duration of the study

Key Exclusion Criteria:

1. Have an ocular condition that could confound study assessments (ocular infection,
herpetic or neurotrophic keratitis, Steven-Johnson Syndrome, etc)

2. Have had penetrating intraocular surgery within 12 months prior to Visit 1

3. Be unwilling to comply with the study requirements

We found this trial at

sites

Clinical Trial Facility in Memphis Tennessee

Memphis, Tennessee

from

Memphis, TN