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A Phase II Study of Bandage Lenses for Ocular Graft-versus-Host Disease After Allogeneic Hematopoietic Cell Transplantation


Phase 2
18 Years
N/A
Open (Enrolling by invite only)
Both
Graft Versus Host Disease, Ophthalmologic Complications

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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 ConsortiumSeattle, Washington  98109