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Topical IL-1-Ra for Treatment of Posterior Blepharitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00681109
Recruitment Status : Completed
First Posted : May 21, 2008
Results First Posted : November 27, 2012
Last Update Posted : January 19, 2018
Sponsor:
Information provided by (Responsible Party):
Reza Dana, MD, Massachusetts Eye and Ear Infirmary

Study Description
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Brief 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.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Study Start Date : January 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Anakinra

Arms and Interventions
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Arm Intervention/treatment
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%


Outcome Measures
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Primary Outcome Measures :
  1. Meibomian Gland Secretion Quality [ Time Frame: 12 Week Time Point ]
    Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality)

  2. Tear Breakup Time (TBUT) [ Time Frame: 12 Week Time Point ]
    TBUT measures the amount of time, in seconds, that the tear film completely coats the ocular surface after each blink. The longer the time the tear film completely coats the ocular surface is considered to be better than a shorter amount of time.

  3. Corneal Fluorescein Staining Score [ Time Frame: 12 Week Time Point ]
    Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy.

  4. Ocular Surface Disease Index (OSDI) [ Time Frame: Baseline and 12 Week Time Point data ]

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



Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00681109


Sponsors and Collaborators
Reza Dana, MD
Investigators
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Principal Investigator: Reza Dana, MD, MPH, MSc Massachusetts Eye and Ear Infirmary
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Reza Dana, MD, Principal Investigator, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT00681109    
Other Study ID Numbers: 07-07-047
First Posted: May 21, 2008    Key Record Dates
Results First Posted: November 27, 2012
Last Update Posted: January 19, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Blepharitis
Meibomian Gland Dysfunction
Eyelid Diseases
Eye Diseases
Interleukin 1 Receptor Antagonist Protein
 Lubricant Eye Drops
Antirheumatic Agents
Ophthalmic Solutions
Pharmaceutical Solutions