Topical IL-1-Ra for Treatment of Posterior Blepharitis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-10-31

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.

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Detailed Description

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Conditions

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Posterior Blepharitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Treatment Arm 1

2.5% IL-1Ra

Group Type ACTIVE_COMPARATOR

2.5% IL-1Ra

Intervention Type DRUG

2.5% custom made topical IL-1Ra three times a day in both eyes for three months

Placebo

Artificial Tear

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

custom eye drop to be applied three times a day in both eyes for three months

Treatment Arm 2

5% IL-1Ra

Group Type ACTIVE_COMPARATOR

5% IL-1Ra

Intervention Type DRUG

5% custom made topical IL-1Ra to both eyes 3 times a day for 3 months

Interventions

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2.5% IL-1Ra

2.5% custom made topical IL-1Ra three times a day in both eyes for three months

Intervention Type DRUG

Placebo

custom eye drop to be applied three times a day in both eyes for three months

Intervention Type DRUG

5% IL-1Ra

5% custom made topical IL-1Ra to both eyes 3 times a day for 3 months

Intervention Type DRUG

Other Intervention Names

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Anakinra 2.5% Kineret 2.5% Artificial Tear Anakinra 5% Kineret 5%

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No