Topical IL-1-Ra for Treatment of Posterior Blepharitis

This study is currently recruiting participants.

Verified by Massachusetts Eye and Ear Infirmary, December 2009

First Received: May 19, 2008 Last Updated: December 18, 2009 History of Changes

Sponsor:	Massachusetts Eye and Ear Infirmary
Information provided by:	Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier:	NCT00681109

Purpose

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

Condition	Intervention	Phase
Posterior Blepharitis	Drug: 2.5% IL-1Ra Drug: Placebo Drug: 5% IL-1Ra	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Safety and Efficacy of Topical Interleukin-1-Receptor Antagonist in the Treatment of Signs and Symptoms of Posterior Blepharitis

Further study details as provided by Massachusetts Eye and Ear Infirmary:

Primary Outcome Measures:

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

The secondary outcome measure will be meibomian gland occlusion and Schirmer with and without anesthesia. [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	75
Study Start Date:	January 2008
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment Arm 1: Active Comparator	Drug: 2.5% IL-1Ra 2.5% custom made topical IL-1Ra three times a day in both eyes for three months
Placebo: Placebo Comparator	Drug: Placebo custom eye drop to be applied three times a day in both eyes for three months
Treatment Arm 2: Active Comparator	Drug: 5% IL-1Ra 5% custom made topical IL-1Ra to both eyes 3 times a day for 3 months

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00681109

Contacts

Contact: Whitney Howe

(617) 391-5894

whitney_howe@meei.harvard.edu

Locations

United States, Massachusetts
Massachusetts Eye and Ear Infirmary	Recruiting
Boston, Massachusetts, United States, 02114
Contact: Whitney Howe 617-391-5894 whitney_howe@meei.harvard.edu
Principal Investigator: Reza Dana, MD, MPH, MSc

Sponsors and Collaborators

Massachusetts Eye and Ear Infirmary

More Information

No publications provided

Responsible Party:	Massachusetts Eye and Ear Infirmary ( Dr. Reza Dana )
Study ID Numbers:	07-07-047
Study First Received:	May 19, 2008
Last Updated:	December 18, 2009
ClinicalTrials.gov Identifier:	NCT00681109 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Therapeutic Uses
Eye Diseases
Eyelid Diseases
Blepharitis

Interleukin 1 Receptor Antagonist Protein
Antirheumatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010