Topical IL-1-Ra for Treatment of Posterior Blepharitis

Phase 1

Completed

Conditions: Posterior Blepharitis

Interventions: Drug: 2.5% IL-1Ra
Drug: Placebo
Drug: 5% IL-1Ra

Registration Number: NCT00681109

Lead Sponsor: Reza Dana, MD

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 Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 75

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment Arm 1	2.5% IL-1Ra	2.5% IL-1Ra
Placebo	Placebo	Artificial Tear
Treatment Arm 2	5% IL-1Ra	5% IL-1Ra

Primary Outcome Measures

Name	Time	Method
Meibomian Gland Secretion Quality	12 Week Time Point	Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality)
Tear Breakup Time (TBUT)	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.
Corneal Fluorescein Staining Score	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.
Ocular Surface Disease Index (OSDI)	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.