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A Multi-Center Study Subjects With Dry Eye Syndrome

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Contents

clinicaltrials.gov/study/NCT01745887
Is a
‌
Clinical study
0

Clinical Study attributes

NCT Number
NCT017458870
Health Conditions in Trial
Dry eye syndrome
Dry eye syndrome
0
Trial Recruitment Size
740
Trial Sponsor
Eleven Biotherapeutics
Eleven Biotherapeutics
0
Clinical Trial Start Date
2012
0
Primary Completion Date
2012
0
Study Completion Date
2012
0
Clinical Trial Study Type
Interventional0
Interventional Trial Purpose
Treatment0
Intervention Type
Drug0
Interventional Trial Phase
Phase 10
Official Name
A Multi-Center, Double Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of EBI-005 Ophthalmic Solution Versus Placebo in Subjects With Dry Eye Syndrome0
Last Updated
August 14, 2013
0
Allocation Type
Randomized0
Intervention Model
Parallel Assignment0
Masking Type
Quadruple0
Masked Party
Outcomes Assessor0
Investigator0
Care Provider0
Participant0

Other attributes

Intervention Treatment
EBI-005-20
Study 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.

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