Phase 3 Study of EBI-005 in Dry Eye Disease (EBI-005)
|ClinicalTrials.gov Identifier: NCT01998802|
Recruitment Status : Completed
First Posted : December 2, 2013
Last Update Posted : June 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Dry Eye Disease (DED)||Drug: Active Comparator EBI-005 Drug: Placebo Comparator||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||670 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Study Start Date :||January 2014|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||April 2015|
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|
- NEI score for Total Corneal Fluorescein Staining (TCFS) [ Time Frame: 3 months ]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 ]Change from baseline to week 12 in Total OSDI score.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998802
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