NCT01998802

Phase 3 Study of EBI-005 in Dry Eye Disease

A Multi-Center, Double-Masked, Randomized, Controlled, Efficacy and Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle Contraol In Subjects With Moderate to Severe Dry Eye Disease

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 670 (actual)
• Sponsor: Eleven Biotherapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase III double-masked, randomized, controlled study evaluating the efficacy of EBI-005 as compared to vehicle given as a topical ophthalmic solution in each eye to subjects with moderate to severe DED three times daily for 12 weeks. Approximately 730 subjects at up to approximately 50 centers in the United States will be screened, enrolled into the study.

Conditions

• Dry Eye Disease (DED)

Interventions

Type	Name	Description
DRUG	Active Comparator EBI-005
DRUG	Placebo Comparator

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-03-01
• Completion: 2015-04-01
• First posted: 2013-12-02
• Last updated: 2015-06-11

Locations

45 sites across 1 country: United States