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

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

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.

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.

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