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

Complete title: A Single-Center Phase II Study of Bandage Lenses for Ocular Graft-versus- Host Disease after Allergenic Hematopoietic Cell Transplantation.

Research Study Number       2617.00
Principal Investigator       Stephanie Lee, MD, MPH
Phase       II

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Research Study Description

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.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- 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

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- 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

Other exclusion criteria may apply.

Research Study Number       2617.00
Contact       Seattle Cancer Care Alliance Intake Office
Telephone       800-804-8824 / 206-288-1024

Chronic Graft Versus Host Disease (cGVHD)

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