NCT02405039

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

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)

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 188 (estimated)
• Sponsor: Eleven Biotherapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye

Interventions

Type	Name	Description
DRUG	EBI-005	EBI-005 is an intervention into one of two (2) study arms; 5 mg/mL topical administered 3 times per day
DRUG	Placebo	Placebo or Vehicle control comparator is an intervention into one of two (2) study arms; vehicle topical administered 3 times per day

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-06-01
• Completion: 2016-07-01
• First posted: 2015-04-01
• Last updated: 2015-06-04

Locations

12 sites across 1 country: United States