Clinical Trial Detail

Researchers are doing this study to see if eye graft-versus-host disease (GVHD) symptoms have improved after two weeks of therapy with bandage lenses. A bandage lens is a disposable soft contact lens used for a diseased or injured part of the eye, called a cornea, to protect or treat it. It is often used after corneal surgery in ophthalmology clinics. Researchers want to know if bandage lenses are helpful in relieving eye symptoms and damage caused by eye GVHD. In this study, researchers want to learn what effects, good or bad, bandage lenses have on people with eye GVHD. They will give the bandage lenses to patients and watch carefully for any side effects

Ages Eligible for Study: 18 Years and older

Genders Eligible for Study: Both

- 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

Other eligibility criteria may apply.

- 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.