A Phase II Study of Bandage Lenses for Ocular Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation
18 Years
N/A
Both
Graft Versus Host Disease, Ophthalmologic Complications
Trial Information
A Phase II Study of Bandage Lenses for Ocular Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation
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.
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Eye subscale of the Lee symptom scale
Outcome Time Frame:
After 2 weeks of bandage lenses use
Safety Issue:
No
Principal Investigator
Stephanie Lee
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Authority:
United States: Federal Government
Study ID:
2617.00
NCT ID:
NCT01616056
Start Date:
June 2012
Completion Date:
Related Keywords:
- Graft Versus Host Disease
- Ophthalmologic Complications
- Chronic graft versus host disease
- Eye
- Graft vs Host Disease
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
