A Multi-Center Study Subjects With Dry Eye Syndrome

Study Overview
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Brief Summary
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This is a Phase 1b, multi-center, double-masked, randomized, placebo-controlled, parallel-group study designed to evaluate the safety and biological activity of two doses of EBI-005 ophthalmic solution versus placebo in subjects with moderate to severe Dry Eye Syndrome. Approximately 72 subjects will be enrolled and randomized in this study at up to 9 centers located in the United States (US). Subjects will be enrolled in two groups or cohorts. The first enrollment group will consist of 33 subjects.

Detailed Description
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To investigate the safety and tolerability of EBI-005 ophthalmic solution compared to placebo in the treatment of patients with moderate to severe Dry Eye Syndrome (DES). To evaluate pharmacokinetic (PK) parameters and immunogenicity of two different doses of EBI-005 ophthalmic solution. To investigate the biological activity of multiple doses of EBI-005 ophthalmic solution compared to placebo as assessed by both objective and subjective assessments. To investigate the comparative dose response of two different doses of EBI-005 ophthalmic solution. To investigate the comparative tolerability of two different doses of EBI-005 ophthalmic solution. To identify key biomarkers in the diagnosis and management of subjects with DES.

Official Title
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A Multi-Center, Double Masked, Randomized, Placebo-Controlled, Dose-Ranging Study of EBI-005 Ophthalmic Solution Versus Placebo in Subjects With Dry Eye Syndrome

Conditions
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Dry Eye Syndrome

Intervention / Treatment
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* Drug: EBI-005-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide written informed consent prior to any study related procedures Are 18 years of age or older Are women of child bearing potential (WOCBP) who are non-pregnant, non-lactating and sexually inactive (abstinent) for 14 days 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 Have a history of Dry Eye Syndrome in both eyes supported by a previous clinical diagnosis Have ongoing Dry Eye Syndrome, in the same eye or both eyes, as defined by the following criteria: A score of ≥23 on OSDI A corneal fluorescein staining score of ≥6 (NEI scale) Have normal lid anatomy Are willing to withhold artificial tears for the duration of the study, with the exception of the study provided artificial tears: Refresh Plus®. Exclusion Criteria: Subjects may not: Have previously used an IL-1 blocker (e.g., Anakinra, Rilonacept or Ilaris). Have an OSDI score ≥90 Have a corneal fluorescein staining score of 15 (NEI scale). NOTE: If one of two eyes has a corneal fluorescein staining score of 15, the subject may be eligible. Within 30 days prior to the screening visit (Visit 1) have taken: Topical cyclosporine (Restasis®) Ocular corticosteroids Autologous serum Topical ocular antibiotics Topical ocular antihistamines or mast cell stabilizers Topical or nasal vasoconstrictors Within 30 days prior to the screening visit (Visit 1) have altered the dose of tetracycline compounds (tetracycline, doxycycline or minocycline).

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EBI-005-2 5mg/ml<br>Administration: 3 times per day | Drug: EBI-005-2<br>* The investigational drug EBI-005-2, is an intervention to three different study arms. One arm gets 5mg/ml, the other gets 20mg/ml and the last arm is Placebo.<br>|
| Active Comparator: EBI-005-2 20 mg/ml<br>Administration: 3 times per day | Drug: EBI-005-2<br>* The investigational drug EBI-005-2, is an intervention to three different study arms. One arm gets 5mg/ml, the other gets 20mg/ml and the last arm is Placebo.<br>|
| Placebo Comparator: EBI-005-2 Placebo<br>Administration: 3 times per day | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OSDI (Ocular Surface Disease Index) | OSDI is a subject assessment tool to determine subject Dry Eye Syndrome symptoms | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in total corneal fluorescein staining | Corneal staining assessment will be performed using methods developed by the NEI Dry Eye Workshop. | 2 months | 
| Symptom Assessment in Dry Eye (Modified SANDE) | Patient Reported Outcome using a Visual Analog Scale for Modified SANDE. | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dry Eye Syndrome, Interleukin 1 Receptor Inhibitor