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Completed

NCT Number: NCT00681109

Topical IL-1-Ra for Treatment of Posterior Blepharitis

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.

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Key information

Conditions

Posterior Blepharitis Eye Diseases Eyelid Diseases Meibomian Gland Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

2.5% IL-1Ra

Drug

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

Drug

custom eye drop to be applied three times a day in both eyes for three months

Other names: Artificial Tear

5% IL-1Ra

Drug

5% custom made topical IL-1Ra to both eyes 3 times a day for 3 months

Other names: Anakinra 5%, Kineret 5%

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Reza Dana, MD

Other

Registry information

Official study title

Safety and Efficacy of Topical Interleukin-1-Receptor Antagonist in the Treatment of Signs and Symptoms of Posterior Blepharitis

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 21, 2008
Registry last updated
Jan 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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