Clinical Trial: A Multi-Center Study Subjects With Dry Eye Syndrome
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Multi-Center, Double Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of EBI-005 Ophthalmic Solution Versus Placebo in Subjects With Dry Eye Syndrome
Brief 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 Summary:
- 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.
Sponsor: Eleven Biotherapeutics
Current Primary Outcome: OSDI (Ocular Surface Disease Index) [ Time Frame: 2 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from baseline in total corneal fluorescein staining [ Time Frame: 2 months ]Corneal staining assessment will be performed using methods developed by the NEI Dry Eye Workshop.
- Symptom Assessment in Dry Eye (Modified SANDE) [ Time Frame: 2 months ]Patient Reported Outcome using a Visual Analog Scale for Modified SANDE.
Original Secondary Outcome: Same as current
Information By: Eleven Biotherapeutics
Dates:
Date Received: December 4, 2012
Date Started: November 2012
Date Completion:
Last Updated: August 13, 2013
Last Verified: August 2013