Topical IL-1-Ra for Treatment of Posterior Blepharitis

Reza Dana, MD

Status and phase: Completed; Phase 2; Phase 1

Conditions: Posterior Blepharitis

Treatments: Drug: 5% IL-1Ra; Drug: 2.5% IL-1Ra; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00681109

07-07-047

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 3 patient groups, including a placebo group

Treatment Arm 1

Active Comparator group

Description:

2.5% IL-1Ra

Treatment:

Drug: 2.5% IL-1Ra

Placebo

Placebo Comparator group

Description:

Artificial Tear

Treatment:

Drug: Placebo

Treatment Arm 2

Active Comparator group

Description:

5% IL-1Ra

Treatment:

Drug: 5% IL-1Ra