Phase 3 Study of EBI-005 in Dry Eye Disease

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Dry Eye Disease (DED)

Intervention / Treatment
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* Drug: Active Comparator EBI-005
* Drug: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Give written informed consent and any authorizations required by local law (e.g., Protected Health Information waiver) prior to performing any study procedures; Are ≥ 18 years of age; Are willing and able to follow instructions and can be present for the required study visits for the duration of the study; Have a history of dry eye disease (DED) in both eyes supported by a previous clinical diagnosis Have normal lid anatomy. If female and of child bearing potential, she must not be not pregnant or lactating and not sexually active (abstinent) within 14 days prior to Visit 1 Exclusion Criteria: Have signs of infection (i.e., fever or current treatment with antibiotics) Have been exposed to an investigational drug/device within the preceding 30 days Be an employee of the site that is directly involved in the management, administration, or support of the study, or be an immediate family member of the same Be unwilling to or unable to comply with the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Comparator: EBI-005<br>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<br> <br> |
| Placebo Comparator: Placebo Comparator<br>One of two study arms: placebo topical administered 3 times per day. | Drug: Placebo Comparator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NEI score for Total Corneal Fluorescein Staining (TCFS) | 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The key secondary endpoint is total OSDI score | Change from baseline to week 12 in Total OSDI score. | 3 months |