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Topical IL-1-Ra for Treatment of Posterior Blepharitis

Primary Purpose

Posterior Blepharitis

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
2.5% IL-1Ra
Placebo
5% IL-1Ra
Sponsored by
Reza Dana, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posterior Blepharitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Placebo Comparator

    Active Comparator

    Arm Label

    Treatment Arm 1

    Placebo

    Treatment Arm 2

    Arm Description

    2.5% IL-1Ra

    Artificial Tear

    5% IL-1Ra

    Outcomes

    Primary Outcome Measures

    Meibomian Gland Secretion Quality
    Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality)
    Tear Breakup Time (TBUT)
    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.
    Corneal Fluorescein Staining Score
    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.
    Ocular Surface Disease Index (OSDI)
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 19, 2008
    Last Updated
    December 19, 2017
    Sponsor
    Reza Dana, MD
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00681109
    Brief Title
    Topical IL-1-Ra for Treatment of Posterior Blepharitis
    Official Title
    Safety and Efficacy of Topical Interleukin-1-Receptor Antagonist in the Treatment of Signs and Symptoms of Posterior Blepharitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2008 (undefined)
    Primary Completion Date
    May 2010 (Actual)
    Study Completion Date
    October 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Reza Dana, MD

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Posterior Blepharitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    75 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment Arm 1
    Arm Type
    Active Comparator
    Arm Description
    2.5% IL-1Ra
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Artificial Tear
    Arm Title
    Treatment Arm 2
    Arm Type
    Active Comparator
    Arm Description
    5% IL-1Ra
    Intervention Type
    Drug
    Intervention Name(s)
    2.5% IL-1Ra
    Other Intervention Name(s)
    Anakinra 2.5%, Kineret 2.5%
    Intervention Description
    2.5% custom made topical IL-1Ra three times a day in both eyes for three months
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Artificial Tear
    Intervention Description
    custom eye drop to be applied three times a day in both eyes for three months
    Intervention Type
    Drug
    Intervention Name(s)
    5% IL-1Ra
    Other Intervention Name(s)
    Anakinra 5%, Kineret 5%
    Intervention Description
    5% custom made topical IL-1Ra to both eyes 3 times a day for 3 months
    Primary Outcome Measure Information:
    Title
    Meibomian Gland Secretion Quality
    Description
    Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality)
    Time Frame
    12 Week Time Point
    Title
    Tear Breakup Time (TBUT)
    Description
    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.
    Time Frame
    12 Week Time Point
    Title
    Corneal Fluorescein Staining Score
    Description
    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.
    Time Frame
    12 Week Time Point
    Title
    Ocular Surface Disease Index (OSDI)
    Description
    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.
    Time Frame
    Baseline and 12 Week Time Point data

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Reza Dana, MD, MPH, MSc
    Organizational Affiliation
    Massachusetts Eye and Ear Infirmary
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    23599118
    Citation
    Amparo F, Dastjerdi MH, Okanobo A, Ferrari G, Smaga L, Hamrah P, Jurkunas U, Schaumberg DA, Dana R. Topical interleukin 1 receptor antagonist for treatment of dry eye disease: a randomized clinical trial. JAMA Ophthalmol. 2013 Jun;131(6):715-723. doi: 10.1001/jamaophthalmol.2013.195.
    Results Reference
    derived

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    Topical IL-1-Ra for Treatment of Posterior Blepharitis

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