Clinical Trial: Topical IL-1-Ra for Treatment of Posterior Blepharitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Reza Dana, MD

Current Primary Outcome:

• Meibomian Gland Secretion Quality [ Time Frame: 16 Weeks ]
• Tear Breakup Time (TBUT) [ Time Frame: 16 Weeks ]
• Cornea Staining Score [ Time Frame: 16 Weeks ]
• Conjunctival Staining Score [ Time Frame: 16 Weeks ]
• Ocular Surface Disease Index (OSDI) [ Time Frame: 16 Weeks ]

  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 ]
• Schirmer Without Anesthesia [ Time Frame: 16 Weeks ]
• Schirmer With Anesthesia [ Time Frame:&n
  
  

  Original Primary Outcome: The primary efficacy measures will be meibomian gland secretion quality, tear break-up time, cornea and conjunctival staining score and OSDI questionnaire score [ Time Frame: 12 Weeks ]
  
  

  Current Secondary Outcome: Occurrence of Adverse Events [ Time Frame: 16 Weeks ]
  
  

  Original Secondary Outcome: The secondary outcome measure will be meibomian gland occlusion and Schirmer with and without anesthesia. [ Time Frame: 12 Weeks ]
  
  Information By: Massachusetts Eye and Ear Infirmary
  

  Dates:
  Date Received: May 19, 2008
  Date Started: January 2008
  Date Completion:
  Last Updated: April 6, 2017
  Last Verified: April 2017