Topical IL-1-Ra for Treatment of Posterior Blepharitis

Reza Dana, MD75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Posterior Blepharitis

Interventions

2.5% IL-1RaDRUG

2.5% custom made topical IL-1Ra three times a day in both eyes for three months

PlaceboDRUG

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

5% IL-1RaDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Meibomian Gland Secretion Quality

Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality)

Time frame: 12 Week Time Point

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.

Time frame: 12 Week Time Point

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.

Time frame: 12 Week Time Point

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.

Time frame: Baseline and 12 Week Time Point data

Data from ClinicalTrials.gov

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