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Bandage Lenses in Treating Patients With Ocular Graft-Versus-Host Disease

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01616056
First received: June 6, 2012
Last updated: June 20, 2012
Last verified: June 2012
History of Changes
  Purpose

Researchers are doing this study to see if eye graft-versus-host disease (GVHD) symptoms have improved after two weeks of therapy with bandage lenses. A bandage lens is a disposable soft contact lens used for a diseased or injured part of the eye, called a cornea, to protect or treat it. It is often used after corneal surgery in ophthalmology clinics. Researchers want to know if bandage lenses are helpful in relieving eye symptoms and damage caused by eye GVHD. In this study, researchers want to learn what effects, good or bad, bandage lenses have on people with eye GVHD. They will give the bandage lenses to patients and watch carefully for any side effects


Condition Intervention Phase
Graft Versus Host Disease
Ophthalmologic Complications
 Biological: graft versus host disease prophylaxis/therapy
Other: questionnaire administration
Other: optical coherence tomography
 Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Phase II Study of Bandage Lenses for Ocular Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Eye subscale of the Lee symptom scale [ Time Frame: After 2 weeks of bandage lenses use ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement in patient-reported symptoms [ Time Frame: Assessed up to 3 months ] [ Designated as safety issue: No ]
  • Improvement in comprehensive ophthalmologic evaluations [ Time Frame: Assessed up to 2 - 4 weeks ] [ Designated as safety issue: No ]
    Vision, intraocular pressure, slit amp exam, Schirmer test, tear break-up time, corneal staining

  • Optical coherence tomography [ Time Frame: Assessed up to 2 - 4 weeks ] [ Designated as safety issue: No ]
    Thickness and roughness of the cornea


Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (bandage lenses)
Patients wear bandage lenses continuously for 3 months in the absence of disease progression or unacceptable toxicity.
 Biological: graft versus host disease prophylaxis/therapy
Wear bandage lenses
Other Names:
  • prophylaxis/therapy, graft versus host disease
  • prophylaxis/therapy, GVHD
Other: questionnaire administration
Ancillary studies
Other: optical coherence tomography
Ancillary studies

Detailed Description:

PRIMARY OBJECTIVES:

I. To determine the symptom improvement after 2 weeks of therapy with bandage lenses.

SECONDARY OBJECTIVES:

I. To confirm short-term safety within 1 month after bandage lenses. II. To determine improvement in ophthalmologic examinations after bandage lenses.

III. To test optical coherence tomography as an objective measure of corneal inflammation.

OUTLINE:

Patients wear bandage lenses continuously for at least 3 months in the absence of disease progression or unacceptable toxicity.

  Eligibility

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

Inclusion Criteria:

  • Diagnosis of chronic GVHD as defined by the National Institutes of Health (NIH) criteria

  • Ocular symptoms of NIH eye score 2 or greater:

    • Score 2: Moderate dry eye symptoms partially affecting activities of daily living (ADL) (requiring drops > 3 x per day or punctal plugs), WITHOUT vision impairment
    • Score 3: Severe dry eye symptoms significantly affecting ADL (special eyewear to relieve pain) OR unable to work because of ocular symptoms OR loss of vision caused by keratoconjunctivitis
  • No new systemic immunosuppressive medications within 1 month prior to enrollment
  • Subject has the ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

  • Absolute neutrophil count < 1000/ul
  • Known hypersensitivity or allergy to contact lenses
  • Evidence of any active viral, bacterial, or fungal infection in the eyes that is progressive despite appropriate treatment
  • Treatment with contact lenses within the previous 3 months for any indication
  • Active psychiatric disorder, substance abuse or any other reason that would interfere with compliance with the study protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01616056

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
National Cancer Institute (NCI)
Investigators
Principal Investigator: Stephanie Lee Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: Lee, Stephanie, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
ClinicalTrials.gov Identifier: NCT01616056     History of Changes
Other Study ID Numbers: 2617.00, NCI-2012-00862
Study First Received: June 6, 2012
Last Updated: June 20, 2012
Health Authority: United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:
Chronic graft versus host disease
Eye

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013