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

• Status: Unknown status
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eleven Biotherapeutics

Criteria

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