NCT01745887

A Multi-Center Study Subjects With Dry Eye Syndrome

A Multi-Center, Double Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of EBI-005 Ophthalmic Solution Versus Placebo in Subjects With Dry Eye Syndrome

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Eleven Biotherapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1b, multi-center, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the safety and biological activity of two doses of EBI-005 ophthalmic solution versus placebo in subjects with moderate to severe Dry Eye Syndrome. Approximately 72 subjects will be enrolled and randomized in this study at up to 9 centers located in the United States (US). Subjects will be enrolled in two groups or cohorts. The first enrollment group will consist of 33 subjects.

Detailed description

* To investigate the safety and tolerability of EBI-005 ophthalmic solution compared to placebo in the treatment of patients with moderate to severe Dry Eye Syndrome (DES). * To evaluate pharmacokinetic (PK) parameters and immunogenicity of two different doses of EBI-005 ophthalmic solution. * To investigate the biological activity of multiple doses of EBI-005 ophthalmic solution compared to placebo as assessed by both objective and subjective assessments. * To investigate the comparative dose response of two different doses of EBI-005 ophthalmic solution. * To investigate the comparative tolerability of two different doses of EBI-005 ophthalmic solution. * To identify key biomarkers in the diagnosis and management of subjects with DES.

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
DRUG	EBI-005-2	The investigational drug EBI-005-2, is an intervention to three different study arms. One arm gets 5mg/ml, the other gets 20mg/ml and the last arm is Placebo.

Timeline

• Start date: 2012-11-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2012-12-10
• Last updated: 2013-08-14

Locations

8 sites across 1 country: United States