Topical IL-1-Ra for Treatment of Posterior Blepharitis

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

Study Overview

• Status: Completed
• Conditions: Posterior Blepharitis
• Intervention / Treatment: Drug: 2.5% IL-1Ra; Drug: Placebo; Drug: 5% IL-1Ra

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Meibomian Gland Secretion Quality	Meibomian Gland Secretion Quality has a range of 0 (normal secretion quality) to 3 (abnormal secretion quality)	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.	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.	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.	Baseline and 12 Week Time Point data

Collaborators and Investigators

• Sponsor: Reza Dana, MD

Publications and helpful links

General Publications

• Amparo F, Dastjerdi MH, Okanobo A, Ferrari G, Smaga L, Hamrah P, Jurkunas U, Schaumberg DA, Dana R. Topical interleukin 1 receptor antagonist for treatment of dry eye disease: a randomized clinical trial. JAMA Ophthalmol. 2013 Jun;131(6):715-723. doi: 10.1001/jamaophthalmol.2013.195.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: May 19, 2008
• First Submitted That Met QC Criteria: May 20, 2008
• First Posted (Estimate): May 21, 2008

Study Record Updates

• Last Update Posted (Actual): January 19, 2018
• Last Update Submitted That Met QC Criteria: December 19, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Eyelid Diseases; Meibomian Gland Dysfunction; Blepharitis; Antirheumatic Agents; Pharmaceutical Solutions; Ophthalmic Solutions; Interleukin 1 Receptor Antagonist Protein; Lubricant Eye Drops
• Other Study ID Numbers: 07-07-047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No