Topical IL-1-Ra for Treatment of Posterior Blepharitis

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts Eye and Ear Infirmary; Reza Dana, MD
• Treatments: Interleukin 1 Receptor Antagonist Protein; Lubricant Eye Drops

Criteria

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