drugset / Trial / NCT01745887
A Multi-Center Study Subjects With Dry Eye Syndrome
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2012-11
- Primary completion
- 2012-11
- Completion
- 2012-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | EBI-005-2 | Unknown | 5 mg/ml | Other |
| Comparator | EBI-005-2 | Unknown | 20 mg/ml | Other |