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.
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
7
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