Phase 2
N=75
Topical IL-1-Ra for Treatment of Posterior Blepharitis
Posterior Blepharitis
Bottom Line
View on ClinicalTrials.gov: NCT00681109 ↗Enrolled (actual)
75
Serious AEs
1.3%
Results posted
Nov 2012
Primary outcome: Primary: Meibomian Gland Secretion Quality — 1.7; 1.7; 1.8 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 2.5% IL-1Ra (Drug); Placebo (Drug); 5% IL-1Ra (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Reza Dana, MD
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Meibomian Gland Secretion Quality |
1.7; 1.7; 1.8 | — |
| PRIMARY Tear Breakup Time (TBUT) |
4.5; 4.4; 3.9 | — |
| PRIMARY Corneal Fluorescein Staining Score |
0.9; 1.4; 1.4 | — |
| PRIMARY Ocular Surface Disease Index (OSDI) |
31.8; 41.8; 31.7 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00681109). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.