Phase 3 Study of EBI-005 in Dry Eye Disease
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.
Dry Eye Disease (DED)
Drug: Active Comparator EBI-005
Drug: Placebo Comparator
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||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|
- NEI score for Total Corneal Fluorescein Staining (TCFS) [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]To evaluate the efficacy of EBI-005 5 mg/mL topical ophthalmic solution given three times daily for 12 weeks as measured by the change in the NEI score for the Total Corneal Fluorescein Staining [sign] from baseline to Week 12 and a change in ocular pain as measured by the painful or sore eye question on the OSDI [symptom] of DED from baseline to Week 12 as compared to vehicle control.
- The key secondary endpoint is total OSDI score [ Time Frame: 3 months ] [ Designated as safety issue: No ]Change from baseline to week 12 in Total OSDI score.
|Study Start Date:||January 2014|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Active Comparator: EBI-005
Drug: EBI-005 The investigational drug EBI-005, is an intervention to one of two study arms: 5 mg/mL topical administered 3 times per day.
|Drug: Active Comparator EBI-005|
Placebo Comparator: Placebo Comparator
One of two study arms: placebo topical administered 3 times per day.
|Drug: Placebo Comparator|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01998802
|Contact: Jennifer Agahigian||5084797919||Jennifer.Agahigian@elevenbio.com|
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