Topical IL-1-Ra for Treatment of Posterior Blepharitis

NCT00681109 | Completed Phase 1 Results

• 1 other identifier: 07-07-047
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Posterior Blepharitis

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (3)

Treatment Arm 1

ACTIVE COMPARATOR

2.5% IL-1Ra

Drug: 2.5% IL-1Ra

Placebo

PLACEBO COMPARATOR

Artificial Tear

Drug: Placebo

Treatment Arm 2

ACTIVE COMPARATOR

5% IL-1Ra

Drug: 5% IL-1Ra

Interventions

2.5% IL-1Ra DRUG

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

Also known as: Anakinra 2.5%, Kineret 2.5%

Treatment Arm 1

Placebo DRUG

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

Also known as: Artificial Tear

Placebo

5% IL-1Ra DRUG

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

Also known as: Anakinra 5%, Kineret 5%

Treatment Arm 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Reza Dana, MD: lead

Related Publications (1)

• 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.

  PMID: 23599118 DERIVED

MeSH Terms

Conditions

Meibomian Gland Dysfunction

Interventions

Interleukin 1 Receptor Antagonist Protein; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Results Point of Contact

• Title: Dr. Reza Dana
• Organization: Massachusetts Eye and Ear Infirmary

Reza_Dana@meei.harvard.edu

(617) 573-4331

Study Officials

• Reza Dana, MD, MPH, MSc

  Massachusetts Eye and Ear Infirmary

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2008
• First Posted: May 21, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: October 1, 2010
• Last Updated: January 19, 2018
• Results First Posted: November 27, 2012

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share