Topical IL-1-Ra for Treatment of Posterior Blepharitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00681109
First received: May 19, 2008
Last updated: December 7, 2012
Last verified: December 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Meibomian Gland Secretion Quality [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
  • Tear Breakup Time (TBUT) [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
  • Cornea Staining Score [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
  • Conjunctival Staining Score [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
  • Ocular Surface Disease Index (OSDI) [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
  • Schirmer Without Anesthesia [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]
  • Schirmer With Anesthesia [ Time Frame: 16 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of Adverse Events [ Time Frame: 16 Weeks ] [ Designated as safety issue: Yes ]

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%

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681109

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

No publications provided by Massachusetts Eye and Ear Infirmary

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov 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
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Blepharitis
Eyelid Diseases
Eye Diseases
Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 29, 2014