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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01616056
First received: June 6, 2012
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

This phase II clinical trial studies how well bandage lenses work in treating patients with ocular graft versus host disease. Bandage lenses may be helpful in relieving eye symptoms and damage caused by eye graft versus host disease.


Condition Intervention Phase
Graft Versus Host Disease
Ophthalmologic Complications
Biological: graft versus host disease prophylaxis/therapy
Other: questionnaire administration
Procedure: 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 Single Center Phase II Study of Bandage Lenses for Ocular Graft-Versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Change in symptoms measured by the Lee eye subscale [ Time Frame: Baseline to 2 weeks ] [ Designated as safety issue: No ]
    Measures at baseline and at 2 weeks after the use of bandage lenses will be compared by paired t-tests. Two-sided P values less than 0.05 will be considered statistically significant. Changes in measures during the 2 weeks will be correlated with patient-perceived symptom changes using regression models.


Secondary Outcome Measures:
  • Change in patient-reported symptoms as measured by the Ocular Surface Disease Index [ Time Frame: Baseline to up to 3 months ] [ Designated as safety issue: No ]
    Measures at baseline and at 2 weeks after the use of bandage lenses will be compared by paired t-tests. Two-sided P values less than 0.05 will be considered statistically significant. Changes in measures during the 2 weeks will be correlated with patient-perceived symptom changes using regression models.

  • Change in patient-reported symptoms as measured by the 11-point eye rating scale [ Time Frame: Baseline to up to 3 months ] [ Designated as safety issue: No ]
    Measures at baseline and at 2 weeks after the use of bandage lenses will be compared by paired t-tests. Two-sided P values less than 0.05 will be considered statistically significant. Changes in measures during the 2 weeks will be correlated with patient-perceived symptom changes using regression models.

  • Perceived change in eye symptoms measure by the 8-level patient-perceived change [ Time Frame: Baseline to up to 3 months ] [ Designated as safety issue: No ]
    Measures at baseline and at 2 weeks after the use of bandage lenses will be compared by paired t-tests. Two-sided P values less than 0.05 will be considered statistically significant. Changes in measures during the 2 weeks will be correlated with patient-perceived symptom changes using regression models.

  • Change in comprehensive ophthalmologic evaluations [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    Measures at baseline and at 2 weeks after the use of bandage lenses will be compared by paired t-tests. Two-sided P values less than 0.05 will be considered statistically significant.

  • Change in optical coherence tomography [ Time Frame: Baseline and 2 weeks ] [ Designated as safety issue: No ]
    Measures at baseline and at 2 weeks after the use of bandage lenses will be compared by paired t-tests. Two-sided P values less than 0.05 will be considered statistically significant.


Estimated Enrollment: 20
Study Start Date: June 2012
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Supportive care (bandage lenses)
Patients wear bandage lenses continuously for at least 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
Procedure: optical coherence tomography
Optional 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 explore the use of 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 graft versus host disease (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: Stephanie Lee Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01616056     History of Changes
Other Study ID Numbers: 2617.00, NCI-2012-00862, 2617.00, P30CA015704
Study First Received: June 6, 2012
Last Updated: June 24, 2014
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 August 27, 2014