Phase 3 Study of EBI-005 in Dry Eye Disease (EBI-005)
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01998802
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