Study of EBI-005 in Dry Eye Disease (DED)

Study Overview
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Brief Summary
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This is a randomized, double masked study designed to evaluate the safety of EBI-005 5 mg/mL topical ophthalmic solution given three times daily (TID) compared to vehicle-control over a one year period in subjects with dry eye disease (DED). Approximately 188 subjects will be enrolled to either EBI-005 or vehicle at up to 15 centers in the United States (US) and Canada.

Official Title
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A Multi-Center, Double-Masked, Randomized, One-Year Safety Study of EBI-005 5 mg/mL Topical Ophthalmic Solution Versus Vehicle-Control in Subjects With Dry Eye Disease (DED)

Conditions
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Dry Eye

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


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Have a history of dry eye disease (DED) in both eyes supported by a previous clinical diagnosis or have a self-reported history of subjective complaints for at least 6 months prior to Visit 1 Are willing and able to follow instructions and can be present for the required study visits for the duration of the study Key Exclusion Criteria: Have an ocular condition that could confound study assessments (ocular infection, herpetic or neurotrophic keratitis, Steven-Johnson Syndrome, etc) Have had penetrating intraocular surgery within 12 months prior to Visit 1 Be unwilling to comply with the study requirements

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

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: EBI-005<br>* EBI-005 is an intervention into one of two (2) study arms; 5 mg/mL topical administered 3 times per day<br>|
| Placebo Comparator: Placebo or Vehicle control Comparator<br>One of two study arms: placebo or vehicle control topical administered 3 times per day | Drug: Placebo<br>* Placebo or Vehicle control comparator is an intervention into one of two (2) study arms; vehicle topical administered 3 times per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of EBI-005 (vital signs) | Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time. | 1 year | 
| tolerability of EBI-005 (adverse events) | Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time. | 1 year | 
| Immunogenicity of EBI-005 (assessment of antibody development (immunogenicity) over time) | Safety will be assessed by vital signs, laboratory changes over time, adverse events, and assessment of antibody development (immunogenicity) over time. | 1 year | 
| Safety of EBI-005 (laboratory changes over time) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological effect of EBI-005 (Changes over time in the OSDI) | Changes over time in the OSDI. | 1 year | 
| Biological effect of EBI-005 (Total corneal fluorescein staining) |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DED, Disease