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
About this trial
This is an interventional treatment trial for 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
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
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
Learn more about this trial
Topical IL-1-Ra for Treatment of Posterior Blepharitis
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