Topical IL-1-Ra for Treatment of Posterior Blepharitis

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness and safety of Topical Interleukin-1-Receptor Antagonist in treatment of signs and symptoms of posterior blepharitis.

Official Title
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Safety and Efficacy of Topical Interleukin-1-Receptor Antagonist in the Treatment of Signs and Symptoms of Posterior Blepharitis

Conditions
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Posterior Blepharitis

Intervention / Treatment
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* Drug: 2.5% IL-1Ra
* Drug: Placebo
* Drug: 5% IL-1Ra


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A diagnosis of posterior blepharitis A negative urine pregnancy test result for women of childbearing potential Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation Normal lid position and closure Ability to understand and provide informed consent to participate in this study Willingness to follow study instructions and likely to complete all required visits. Exclusion Criteria: History of Stevens-Johnson syndrome or ocular pemphigoid History of eyelid surgery Intra-ocular surgery or ocular laser surgery within 3 months History of microbial keratitis, including herpes Active ocular allergies Corneal epithelial defect > 1mm2 Use of topical steroids or Restasis within the past 2 weeks Use of tetracycline compounds (tetracycline, doxycycline, and minocycline) within the last month Use of isotretinoin (Accutane) within the past 6 months Have had any previous treatment with Anakinra (Kineret®) or any therapeutic agent targeted at IL-1 blockade Pregnant or lactating women Signs of current infection, including fever and current treatment with antibiotics Liver, renal, or hematologic disease The use of any other investigational drug

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment Arm 1<br>2.5% IL-1Ra | Drug: 2.5% IL-1Ra<br>* 2.5% custom made topical IL-1Ra three times a day in both eyes for three months<br>* Other names: Kineret 2.5%;|
| Placebo Comparator: Placebo<br>Artificial Tear | Drug: Placebo<br>* custom eye drop to be applied three times a day in both eyes for three months<br>* Other names: Artificial Tear;|
| Active Comparator: Treatment Arm 2<br>5% IL-1Ra | Drug: 5% IL-1Ra<br>* 5% custom made topical IL-1Ra to both eyes 3 times a day for 3 months<br>* Other names: Kineret 5%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Meibomian Gland Secretion Quality | Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality) | 12 Week Time Point | 
| Tear Breakup Time (TBUT) | TBUT measures the amount of time, in seconds, that the tear film completely coats the ocular surface after each blink. The longer the time the tear film completely coats the ocular surface is considered to be better than a shorter amount of time. | 12 Week Time Point | 
| Corneal Fluorescein Staining Score | Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy. | 12 Week Time Point | 
| Ocular Surface Disease Index (OSDI) | The Ocular Surface Disease Index (OSDI) is a 12-item questionnaire designed to provide a rapid assessment of the symptoms of ocular irritation consistent with dry eye disease and their impact on vision-related functioning. The 12 items of the OSDI questionnaire are graded on a scale of 0 to 4, where 0 indicates none of the time; 1, some of the time; 2, half of the time; 3, most of the time; and 4, all of the time. The total OSDI score is then calculated on the basis of the following formula: OSDI=[(sum of scores for all questions answered) x 100]/[(total number of questions answered) x 4]. Thus, the OSDI is scored on a scale of 0 to 100, with higher scores representing greater disability. A negative change from baseline indicated an improvement in vision-related functioning. OSDI was assessed on the Baseline Visit, Week 2, Week 6, Week 12, Week 16. Change indicated represents change from Baseline to Week 12. | Baseline and 12 Week Time Point data |