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Topical IL-1-Ra for Treatment of Posterior Blepharitis

This study has been completed.
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary Identifier:
First received: May 19, 2008
Last updated: December 7, 2012
Last verified: December 2012
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.

Condition Intervention Phase
Posterior Blepharitis
Drug: 2.5% IL-1Ra
Drug: Placebo
Drug: 5% IL-1Ra
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Topical Interleukin-1-Receptor Antagonist in the Treatment of Signs and Symptoms of Posterior Blepharitis

Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:
  • Meibomian Gland Secretion Quality [ Time Frame: 16 Weeks ]
  • Tear Breakup Time (TBUT) [ Time Frame: 16 Weeks ]
  • Cornea Staining Score [ Time Frame: 16 Weeks ]
  • Conjunctival Staining Score [ Time Frame: 16 Weeks ]
  • Ocular Surface Disease Index (OSDI) [ Time Frame: 16 Weeks ]

    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 Screening Visit, Week 2, Week 6, Week 12, Week 16. Change indicated represents change from Screening to Week 12.

  • Meibomian Gland Occlusion [ Time Frame: 16 Weeks ]
  • Schirmer Without Anesthesia [ Time Frame: 16 Weeks ]
  • Schirmer With Anesthesia [ Time Frame: 16 Weeks ]

Secondary Outcome Measures:
  • Occurrence of Adverse Events [ Time Frame: 16 Weeks ]

Enrollment: 75
Study Start Date: January 2008
Study Completion Date: October 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Treatment Arm 1
2.5% IL-1Ra
Drug: 2.5% IL-1Ra
2.5% custom made topical IL-1Ra three times a day in both eyes for three months
Other Names:
  • Anakinra 2.5%
  • Kineret 2.5%
Placebo Comparator: Placebo
Artificial Tear
Drug: Placebo
custom eye drop to be applied three times a day in both eyes for three months
Other Name: Artificial Tear
Active Comparator: Treatment Arm 2
5% IL-1Ra
Drug: 5% IL-1Ra
5% custom made topical IL-1Ra to both eyes 3 times a day for 3 months
Other Names:
  • Anakinra 5%
  • Kineret 5%


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00681109

Sponsors and Collaborators
Massachusetts Eye and Ear Infirmary
Principal Investigator: Reza Dana, MD, MPH, MSc Massachusetts Eye and Ear Infirmary
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Massachusetts Eye and Ear Infirmary Identifier: NCT00681109     History of Changes
Other Study ID Numbers: 07-07-047
Study First Received: May 19, 2008
Results First Received: December 19, 2011
Last Updated: December 7, 2012

Additional relevant MeSH terms:
Eyelid Diseases
Eye Diseases
Interleukin 1 Receptor Antagonist Protein
Lubricant Eye Drops
Antirheumatic Agents
Ophthalmic Solutions
Pharmaceutical Solutions processed this record on April 27, 2017